Author Archives: Tapan Ray

Public Healthcare Space: Evaluating Three Fresh Edicts

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Medicines constitute a significant cost component of modern healthcare systems across the world. However, in India the situation is even worse, where as per recent studies, drugs contribute as high as around 70 percent of the total treatment cost. This is mainly because overall healthcare system in the country is fundamentally different not just from the developed world, but also from many other developing countries like, China, Brazil, South Africa and Thailand, to name a few.

In most of those countries significant expenses towards healthcare including medicines are reimbursed either by the Governments or through health insurance or similar mechanisms. However, the Indian situation is just the reverse, where around 72 percent of overall healthcare costs, including medicines, are private or Out of Pocket (OoP), incurred by the individuals/families.

According to a recent report, ‘about 38 million people in India (which is more than Canada’s population) fall below the poverty line every year due to healthcare expenses, of which 70% is on purchase of drugs’, as stated above.

In this context, it is worth noting that for patented drugs, the Drug Policy of December 2012 clearly articulates that Government of India will follow the approach of price negotiation with the respective companies. Unfortunately, work done in this so important area by the concerned authority, so far, has been rather superficial, if not shoddy. Most of the patented products, which are prohibitively expensive, continue to remain out of reach of a vast majority of patients in india.

Expenditure towards healthcare – a fundamental need:

Expenditure towards healthcare in India, which is largely private, highly exploitative and thus expensive, is absolutely essential for all, either to be able to earn a living for a family or for maintaining a reasonable quality of life.

According to an ‘Access Survey’ conducted by IMS Consulting Group in 2012, ‘Out Patient (OP)’ treatment costs in private care is ~2-3 times that of public and in case of ‘In-Patient (IP)’ care it is ~4-8 times the cost of Public care.

Focus has not been just enough:

Since 1970, the Government of India and various States have been adopting  measures including, National Health Mission (NHM), Rashtriya Swasthya Bima Yojana (RSBY), Drug Price Control Order (DPCO), besides others, to make healthcare in general and medicines in particular affordable and accessible to the common man. However, these measures though essential, have not delivered quite well when measured against the set objectives. This keeps on happening, due to lack of accountability and inefficient Government control over the processes involved together with fast increasing exploitative mindset in the private healthcare space, over the last several decades.

Health being a State subject inequity in access:

Health being a State subject in India, there has been large variations in public healthcare spend within various States of the country. Some of the poorer States have low  per capita public healthcare expenditure and some of the richer states incur significantly more, leading to huge inequity of access, especially among the poorer sections of the society. (Source: IMS Consulting 2012)

Three fresh edicts:

In the above backdrop, the decision of the Government of India to increase the National Health Expenditure Budget from 1.2% to 2.5% of GDP in the 12th Five Year Plan of India in 2012 has the potential to be a game changer in the public healthcare space of India.

It is envisaged that this decent increase in the budgetary allocation will help initiating the process of Universal Health Care (UHC) to ensure free access to essential health services for every citizen of the country, including cashless in-patient and out-patient treatment for primary, secondary and tertiary care.

Probably as a precursor to UHC, the Government of India has announced three fresh edicts:

1. Budgetary clearance for ‘Free distribution of essential medicines’ by the States

2. Notification for operationalizing the new ‘Central Medical Services Society (CMSS)’ to streamline the drug procurement system 

3. Announcement for implementation of ‘Standard Treatment Guidelines (STGs)’ 

The above edicts are indeed laudatory, as these measures, if taken effectively in tandem would also help maximizing overall productivity of the public healthcare delivery systems, immensely.  This is expected mainly because, the process would require avoidance of unnecessary medicines and diagnostics tests, chain of multiple doctor visits starting from GPs, specialists to super specialists, besides simultaneous re-engineering of below par public healthcare delivery systems of the country.

1. Budgetary clearance for free distribution of essential medicines by the States:

Late 2012, the Union Government made its first major move by formally clearing Rs. 13,000 Crore  (around US$ 2.2 billion) towards providing free medicines for all through government hospitals and health centers. The State Governments under National Health Mission to utilize this fund for purchase and free distribution of essential medicines. Some State Governments are already in the process of implementing this scheme, though effective implementation of the same, across the country, still remains a challenge.

This new scheme, I reckon, has also the potential to hasten the overall growth of the pharmaceutical industry, as poor patients who could not afford will now have access to essential medicines. On the other hand, rapidly growing middle class population will continue to favor branded generic drugs prescribed by the doctors at the private hospitals and clinics.

Some people are apprehending that generic drug makers will have brighter days as the project starts rolling on. This apprehension is based on the assumption that large branded generic players will be unable to take part in this big ticket drug procurement process of the Government, which seems to be imaginary at this stage.

However, in my view, it could well be a win-win situation for all types of players in the industry, where both the generic-generic and branded-generic businesses could continue to grow simultaneously.

That said procedural delays and drug quality issues, while procuring cheaper generics, might pose to be a great challenge for the Government to ensure speedier implementation of this project. Drug regulatory and law enforcing authorities will require to be extremely vigilant to ensure that while sourcing cheaper generic drugs, “Public health and safety” due to quality issues do not get compromised in any way.

POTENTIALITY: Significant increase in access to medicines and simultaneous sharp reduction on OoP expenses.

2. Operationalization of CMSS for drug procurement:

Recently this year, the Union Health Ministry issuing the final notification reportedly has made the drug procurement system through Central Medical Services Society (CMSS) formally operational.

The drug procurement for different flagship program, of the Government like National Health Mission, will now be done through the CMSS.

The notification says:

  • The CMSS will be responsible for procuring health sector goods in a transparent and cost-effective manner and distributing them to the States/UTs by setting up an IT enabled supply chain infrastructure including warehouses in 50 locations.
  • The main objective of CMSS is to ensure uninterrupted supply of health-sector goods to the state Government, which will then maintain the flow to the govt. health facilities such as district hospitals, primary health centers and community health centers.
  • All decisions on procurement will be taken by the CMSS without any reference to the Ministry of Health and Family Welfare.
  • The Ministry will be responsible only for policy decisions concerning procurement and for monitoring its performance.
  • The CMSS will also assist the state governments to set up similar organizations in states to reform their procurement.
  • The Government has appointed the Director General and other key persons to run the organization, which will look to eliminate deficiencies in the existing system of purchasing medicines, vaccines, contraceptives and medical equipment for all government’s flagship program.
  • At present, the ministry procures drugs departmentally and through agents, drawing flaks and raking controversies at regular intervals.

This seemingly transparent drug procurement process for public use, would prompt tough price negotiations with the manufacturers for purchase of medicines leading to significant reduction in drug prices, as evidenced already in the States like, Tamil Nadu and Rajasthan.

POTENTIALITY: Significant reduction in public healthcare costs, especially for medicines.

3. Announcement for implementation of Standard Treatment Guidelines (STGs):

Another recent news that Standard Treatment Guidelines (STGs) for 20 disciplines will soon be put in place in India is indeed a breath of fresh air. The centers of excellence for healthcare, both public and private, for around 1.2 billion population of the country, are still rather limited.

STG is usually defined as a systematically developed statement designed to assist practitioners and patients in making decisions about appropriate cost-effective treatment for specific disease areas.

For each disease area, the treatment should include “the name, dosage form, strength, average dose (pediatric and adult), number of doses per day, and number of days of treatment. STG also includes specific referral criteria from a lower to a higher level of the diagnostic and treatment requirements.

For an emerging economy, like India, formulation of STGs would ensure cost-effective healthcare benefits to a vast majority of its population.

STGs, therefore, will provide:

- Standardized guidance to practitioners

- Cost-effective ‘health outcomes’ based services

The Ministry of Health is now reportedly mulling to streamline in a phased manner the disease treatment procedures and protocols by introducing STGs in 20 disciplines under the ‘Clinical Establishments Act’ of the country. These disciplines are Cardiovascular, Endocrinology, ENT, Gastroenterology, General Surgery, Interventional Radiology, Laboratory Medicine, Obstetrics and Gynecology, Organ Transplant, Pediatrics, Oncology, Urology, Nephrology, GI Surgery, Medicine Respiratory, Medicine Non-Respiratory, Critical Care, Ophthalmology, Neurology and Orthopedics.

The National Council for Clinical Establishments (NCCE) is the apex body under the Clinical Establishments Act. STGs, therefore, will be binding on all hospitals and establishments registered under the Clinical Establishments Act 2010.

The Council has already deliberated on the draft STGs prepared by the experts in the respective disciplines of medicines. Surgical intervention in cardiovascular diseases reportedly will assume priority while implementing the STGs.

It is expected that the first of the STGs will be announced soon.

Currently only Uttar Pradesh, Mizoram, Sikkim, Rajasthan, Arunachal Pradesh, Himachal Pradesh and Jharkhand, apart from all Union Territories, have adopted the Act. Again, health being a State subject in India, all the States of the country will need to enforce this Act to make the initiative successful. However, states like West Bengal have their own Clinical Establishment Act, while Tamil Nadu has its own STGs.

Incidentally, putting STGs in place has been one of the long-standing demands of many, including the medical insurance companies. This is mainly because, laid-down protocols will make the hospitals avoiding unnecessary procedures on insured patients, thereby reducing the cost of treatment significantly.

POTENTIALITY: Huge reduction in healthcare cost, avoiding wastage in every step of any disease treatment. This could also help the medical insurance companies containing hospitalization costs, hopefully leading to reduced insurance premium.

Conclusions: 



All these three edicts of the Government, do promise a huge potential to help containing the overall cost of treatment in general and the costs of medicines in particular.

Effective implementation of these important initiatives would call for a significant change in mindset of all concerned. Doctors, hopefully, would also avoid using those expensive drugs having no significant improvement in ‘health outcomes’ over the cheaper alternatives.

STGs would initially need to be encouraged not just through self-regulation of the medical profession, but by the pharmaceutical industry and other allied interested parties in this area, as well. If ‘self-regulation’ does not work, stringent regulatory measures must be enforced by the Government to protect patients’ health interest.

No doubt both the Union and the State Governments of India would still have lot to chew in pursuit of ensuring affordable healthcare in general and medicines in particular, to all.

That said, would expectations of crafty implementation of these edicts, at least, flicker a ray of hope in an otherwise gloomy and exploitative overall healthcare environment of the country?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

‘Big Pharma’ Prowls Falter: Triggers Off Yet Another Critical Debate

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The ‘Big Pharma’ prowls faltered yet again exposing the ‘fault line’ to all, when the GSK global head honcho, a pharma icon in his own right, Sir Andrew Witty supported the pharmaceutical policy of India, while in the country earlier this month. This support is quite in contrary to arrogant displeasure being expressed by his MNC counterparts against the pharma regime in India up until now.

Sir Andrew reportedly spoke against the usual pharma MNC practices of charging very high prices for patented medicines during an interview and said that multinationals need to look at things from India’s perspective. 

The above comment, when analyzed especially in context of one of the recent actions of Big Pharma MNCs complaining in writing to President Obama against India’s prevailing pharmaceutical regime, the fault line gets clearly visible.

In this context, a recent report captured the anger and desperation of Big Pharma. This hostility vindicates the general apprehensions in India that MNCs are once again pushing for a stringent patent regime in the country, against the general health interest of Indian patients for access to affordable newer medicines.

Quoting US Chamber of Commerce’s Global Intellectual Property Center another report reconfirmed the impatient prowl of the mighty lobby group in the corridors of power. This piece states, “Recent policy and judicial decisions (Glivec judgment and Nexavar) that invalidate intellectual property rights, which have been increasing in India, cast a daunting shadow over its otherwise promising business climate.” 

The ‘fault line’, thus surfaced, triggers off yet another critical debate, especially related to the slugfest on a stringent pharmaceutical product patent regime in India, as follows:

“Does Stricter IPR Regime Spur Pharma Innovation?”

Global innovator companies strongly argue that stringent Intellectual Property Rights (IPR) and stricter enforcement of IP laws have strong link with fostering innovation leading to a robust economic growth for any nation.

However, another group of thought leaders opine just the opposite. They argue that strong IPR and IP laws have little, if any, to do with fostering innovation and economic growth, as there are no robust research findings to drive home the above point.

It has been noticed that the MNC lobby groups quite often very cleverly use their magic word ‘innovation’ on a slightest pretext with an underlying desire of having a ‘very strict patent regime’ in India. Thus they seem to be trying to mislead the common man, as if India is against innovation.

Comment of the Chairman of National Innovation Council of India:

On September 15, 2012, while delivering his keynote address in a pharmaceutical industry function, Dr. Sam Pitroda, the Chicago based Indian, creator of the telecom revolution in India, Chairman of the National innovation Council and the Advisor to the Prime Minister on Public Information, Infrastructure & Innovations, made a profound comment for all concerned to ponder, as follows:

“Everyone wants to copy the American model of development.  I feel that this model is not scalable, sustainable, desirable and workable.  We have to find an Indian Model of development which focuses on affordability, scalability and sustainability.”

Recent Indian stand:

On March 5, 2013, the Government of India made a profound statement on the subject of ‘Innovation and Small and Medium Enterprises (SMEs)’ at the TRIPS Council meeting covering the following points:

  • There is no direct correlation between IP and Innovation even for the Small and Medium Industries.
  • The technological progress even in the developed world had been achieved not through IP protection but through focused governmental interventions.
  • The proponents of this Agenda Item have reached the present stage of technological development by focusing solely on the development of their own domestic industry without caring for the IPRs of the foreigners or the right holders.
  • After achieving a high level of development, they are now attempting to perpetuate their hold on their technologies by making a push towards a ‘TRIPS plus’ regime.
  • Their agenda is not to create an environment where developing countries progress technologically, but to block their progress through stringent IP regime.
  • It is essential that the flexibilities provided by the TRIPS Agreement need to be secured at any cost, if the people in the developing countries are to enjoy the benefits of innovations.

A Wharton Professor’s view:

As the Wharton professor of Healthcare Management Mark V. Pauly has been quoted saying that the link between patent protection and innovation has never been definitely proven.

However, Pauly reportedly is aware that the innovator global pharma companies do say, ‘If you don’t allow us to reap the benefits of our R&D expenditure, we won’t put as much into it, and we won’t invent as many great things’.

However, the Wharton Professor counters it by saying, “The problem is that nobody really knows how much less innovation there would be if there were less patent protection. We just don’t know what the numbers are.”

The above report says, according to Pauly, the onus to prove that patent protection matters should be on the drug industry itself.

He argues, “Rather than always just insisting you should never limit intellectual property protection, they really ought to develop some evidence to show that without that protection, there would be an impact on the rate of adoption of new products. Everybody has an opinion, but nobody knows the facts.“

A French Professor’s view:

In another WIPO seminar held on June 18, 2013, Margaret Kyle, a Professor at the Toulouse School of Economics and the Université de Toulouse I in France, reportedly presented preliminary findings of a study.

This paper explored in detail the impact of World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in various areas related to the speed of launch, price, and volume of sales of drugs across countries and across different drug products.

In this study, as the above report states, Kyle analyzed the trade-off between the dynamic and static effects of Intellectual Property Rights (IPRs).

The dynamic effect of IPRs was considered as an incentive for innovation based on the general belief that patent protection, through granting market exclusivity, incentivizes companies to invest in the research and development (R&D) to develop new drugs.

On the other hand, the static effect of IPRs in the short term is that granting market exclusivity often leads to innovator companies pricing their products at levels, which will be unaffordable by a large number of patients, especially in lower-income countries.

Kyle explained that the results implied as follows:

  • IPRs are neither necessary nor sufficient to launch new pharmaceutical products.
  • The existence of a product patent does not always inhibit generic imitation, nor does the lack of such a patent necessarily deter an originator from making a product available in a given market.

Other eminent voices:

While highlighting that TRIPS-Plus intellectual property protection is passed by some developing countries in order to implement FTA obligations, another recent paper presents the following examples in support of the argument that there no correlation between strong IP laws and fostering innovation:

  • UK Commission on Intellectual Property Rights. Integrating Intellectual Property Rights and Development Policy. 2002. (Link)

“…Strong IP rights alone provide neither the necessary nor sufficient incentives for firms to invest in particular countries… The evidence that foreign investment is positively associated with IP protection in most developing countries is lacking.”

  • Robert L. Ostergard., Jr. “Policy Beyond Assumptions: Intellectual Property Rights and Economic Growth.” Chapter 2 of The Development Dilemma: The Political Economy of Intellectual Property Rights in the International System.  LFB Scholarly Publishing, New York. 2003

“…No consistent evidence emerged to show that IPR contributed significantly to economic growth cross-nationally.  Furthermore, when the nations are split into developed and developing countries, results to suggest otherwise did not emerge.”

  • Carsten Fink and Keith Maskus. “Why We Study Intellectual Property and What We Have Learned.” Chapter one of Intellectual Property and Development: Lessons from Economic Research. 2005. (Link)

“Existing research suggests that countries that strengthen their IPR are unlikely to experience a sudden boost in inflows of FDI.  At the same time, the empirical evidence does point to a positive role for IPRs in stimulating formal technology transfer.”

“Developing countries should carefully assess whether the economic benefits of such rules outweigh their costs. They also need to take into account the costs of administering and enforcing a reformed IPR system”

“We still know relatively little about the way technology diffuses internationally.”

  • Keith Mascus. “Incorporating a Globalized Intellectual Property Rights Regime Into an Economic Development Strategy.”  Ch. 15 of Intellectual Property, Growth and Trade. (ed. Mascus). Elsevier.  2008.

“Middle income countries must strike a complicated balance between promoting domestic learning and diffusion, through limited IP protection, and gaining greater access to international technologies through a strong regime… it makes little sense for these nations to adopt the strongly protectionist IP standards that exist in the U.S., the EU and other developed economies.  Rather, they should take advantage of the remaining policy space provided by the TRIPS Agreement.”

“It is questionable whether the poorest countries should devote significant development resources to legal reforms and enforcement of IPR.”

  • Kamal Saggi. “Intellectual Property Rights and International Technology Transfer via Trade and Foreign Direct Investment. Ch. 13 of Intellectual Property, Growth and Trade. (ed. Mascus). Elsevier.  2008.

“Overall, it is fair to say that the existing empirical evidence regarding the overall technology-transfer impacts of increased IPR protection in developing countries is inconclusive at this stage.  What is not yet clear is whether sufficient information flows will be induced to procure significant dynamic gains in those countries through more learning and local innovation.”

  • Alexander Koff, Laura Baughman, Joseph Francois and Christine McDaniel. “Study on the Economic Impact of ‘TRIPS-Plus’ Free Trade Agreements.”  International Intellectual Property Institute and the U.S. Patent and Trademark Office. August 2011.

“TRIPS-Plus IPRs viewed as ‘important, but not essential’ for attracting investment. Many other factors matter like, taxes, human capital, clustering, etc.”

Patients versus Patents:

Another recent  article on this subject states as follows:

“Compulsory licensing and stricter patentability standards allow domestic manufacturers to produce lower-cost versions of patented NCD medications and break into lucrative therapeutic areas, such as oncology, in which multinational drug firms are heavily invested.”

The paper clearly highlights, “If patients are pitted against patents, international support for IP protection—upon which drug firms and many other developed country industries now heavily rely—will again diminish.”

Yet another article published in The New England Journal of Medicine, July 17, 2013 states:

“Patents are government-granted monopolies. As monopolies, they can drive the prices of drugs up dramatically. For example, in 2000, when only patented antiretroviral drugs for Human Immunodeficiency Virus (HIV) infection were widely available, they cost approximately $10,000 per person per year, even in very poor countries. Today, these same medicines cost $150 or less if they are purchased from Indian generics companies…. patents cause especially acute problems for access to medicines in developing countries – not only because of low incomes but also because insurance and price-control systems are often absent or inadequate.” 

A WHO Report:

To chart the way forward at the backdrop of ongoing global debate elated to the relationship between intellectual property rights, innovation and public health, the World Health Assembly decided in May 2003 to give an independent Commission the task of analyzing this key issue. Accordingly, the Director-General of WHO established the Commission in February 2004. This report titled, “Public health, innovation and intellectual property rights” was published in 2006 and articulated that neither innovation nor access depend on just intellectual property rights and highlighted, among others, the following:

  • Intellectual property rights have an important role to play in stimulating innovation in health-care products in countries where financial and technological capacities exist, and in relation to products for which profitable markets exist.
  • In developing countries, the fact that a patent can be obtained may contribute nothing or little to innovation if the market is too small or scientific and technological capability inadequate.
  • In the absence of effective differential and discounted prices, patents may contribute to increasing the price of medicines needed by poor people in those countries.
  • Although the balance of costs and benefits of patents will vary between countries, according to their level of development and scientific and technological infrastructure, the flexibility built into the TRIPS agreement allows countries to find a balance more appropriate to the circumstances of each country.

India – now the most attractive global investment destination:

Trashing the anger and displeasure of pharma MNCs, as per the latest international survey, India reportedly has emerged as the most attractive global investment destination followed by Brazil and China. It is worth noting that even recently, during April- June period of 2013, with a capital inflow of around US$ 1 billion, the pharma sector became the brightest star in the FDI landscape of India.

Conclusion:

In the Indian context, a 2013 paper titled, “Intellectual Property Protection and Health Innovation: Concerns for India” published by Center for WTO Studies highlights that the regime change in the patent system has not been very supportive for improving access to medicines in India. It reiterates, it has not been established yet that a stricter patent regime in the developing countries like India, has helped health innovation and access to medicines at economically viable prices.

The paper recommends, although India is trying to incorporate all the flexibilities under TRIPS in its Patents Act, the ‘Indian Policy Makers’ should not give in to the pressure of western powers to make IPR more stringent in the country.

In the backdrop of arrogance exhibited by Big Pharma MNCs, in general, against Indian policies and judicial verdicts on this subject, the comments made by Sir Andrew on the issue, as deliberated above, are indeed profound and far reaching. However, it clearly exposes the fault line in the collective mindset of pharma MNCs, without any ambiguity.

I shall not be surprised either, if clever attempts are made now by the MNC lobby groups to negate or trivialize the profoundness of this visionary statement not just in India, but beyond its shores, as well.

Further, as stated above recent emergence of India as the most attractive global investment destination with pharma leading the deck is a point worth noting, more in the context of policy and statutes that India has decided to follow.

Be that as it may, it is beyond the scope of any doubt that innovation or for that matter encouraging innovation still remains the wheel of progress of any nation.

However, have we garnered enough evidence yet, to establish that stringent IPR regime with absolute pricing freedom would lead to fostering more innovation leading to well-being of people of the developing countries, like India?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

 

 

Pharma FDI Debate: Highly Opinionated, Sans Assessment of Tangible Outcomes?

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In 2001, the Government of India (GoI) allowed 100 percent Foreign Direct Investments (FDI) in the pharmaceutical sector through automatic route to attract more investments for new asset creation, boost R&D, new job creation and ultimately to help aligning Indian pharma with the modern pharma world in terms of capacity, capability, wherewithal, reach and value creation.

Thereafter, several major FDI followed, such as:

No. Company Acquirer Value US$M Year
1. Ranbaxy Daiichi Sankyo 4600 2008
2. Shantha Biotechnics Sanofi Pasteur 781 2009
3. Piramal Healthcare Abbott 3700 2010
4. Orchid Chemicals Hospira 200 2012
5. Agila Specialties Mylan 1850 2013

FDI started coming: 

Even recently, in April- June period of 2013, with a capital inflow of around US$ 1 billion, the pharma sector became the brightest star in otherwise gloomy FDI scenario of India.

However, out of 67 FDI investments till September 2011, only one was in the Greenfield area. It is now clear that the liberal pharma FDI policy is being predominantly used for taking overs the domestic pharma companies, as indicated earlier.

The Reserve Bank of India (RBI) data reveals that between April 2012 and April 2013, US$ 989 million FDI was received in brownfield investments, and just US$ 87.3 million in Greenfield investments.

As a result, in 2010 pharma Multi-National Corporations (MNCs) captured over 25 percent of the domestic Indian market, as against just around 15 percent in 2005.

An assessment thus far: 

While assessing the outcomes of liberal pharma FDI regime, especially at a time when India is seeking foreign investments in many other sectors, following facts surface:

New asset creation:

Most of the FDIs in pharma, during this period, have been substitution of domestic capital by foreign capital, rather than any significant new asset creation.

Investment in fixed assets (1994-95 to (2009-10):

Companies Rs. Crore Contribution %
Indian 54,010 94.7
MNC 3,022 5.3
Total 57,032 100

(Source: IPA)

Thus contrary to the expectations of GoI, there has been no significant increase in contribution in fixed assets by the pharma MNCs, despite liberalization of FDI.

Similarly, the available facts indicate that 100 percent FDI through automatic route in the pharma sector has not contributed in terms of creation of new modern production facilities, nor has it strengthened the R&D space of the country. The liberalized policy has not contributed to significantly increase in the employment generation by the pharma MNCs in those important areas, either.

The following figures would vindicate this point:

R&D Spend:

Companies 1994-95(Rs. Crore) Contribution % 2009-10(Rs. Crore) Contribution %
Indian 80.61 55.7 3,342.22 78.1
MNC 64.13 44.3 934.40 21.9
Total 144.74 100 4,276.32 100

(Source: IPA)

The above table vindicates that post liberalization of FDI regime, MNC contribution % in R&D instead of showing any increase, has significantly gone down.

Wage Bill/ Job Creation:

Companies 1994-95(Rs. Crore) Contribution % 2009-10(Rs. Crore) Contribution %
Indian 664 65.5 8,172 87.1
MNC 350 34.5 1,215 12.9
Total 1,014 100 9,387 100

(Source: CMIE)

In the area of job creation/wage bills, as well, liberalized FDI has not shown any increasing trend in terms of contribution % in favor of the MNCs.

Delay in launch of cheaper generics:

There are instances that the acquired entity was not allowed to use flexibilities such as patent challenges to introduce new affordable generic medicines.

The withdrawal of all patent challenges by Ranbaxy on Pfizer’s blockbuster medicine Lipitor filed in more than eight countries immediately after its acquisition by Daiichi-Sankyo, is a case in point.

Key concerns expressed:

Brownfield acquisitions seem to have affected the entire pharma spectrum, spanning across manufacturing/ marketing of oral formulations; injectibles; specialized oncology verticals; vaccines; consumables and devices, with no tangible perceptible benefits noted just yet.

Concerns have been expressed about some sectors, which are very sensitive, such as, cancer injectibles and vaccines.

Moreover, domestic Indian pharma exports generic medicines worth around US$ 13 billion every year establishing itself as a major pharmaceutical exporter of the world and is currently the net foreign exchange earner for the country. If the Government allows the domestic manufacturing facilities of strategic importance to be taken over by the MNCs, some experts feel, it would adversely impact the pharmaceutical export turnover of the country, besides compromising with the domestic capacity while facing epidemics, if any or other health exigencies. It would also have a negative fall out on the supply of affordable generic medicines to other developing nations across the world.

Countries such as Brazil and Thailand have a robust public sector in the pharma space. Therefore, their concerns are less. Since India doesn’t have a robust public sector to fall back on, many experts feel that unrestrained acquisitions in the brownfield sector could be a serious public health concern.

Some conditions proposed:

The DIPP proposal reportedly wants to make certain conditions mandatory for the company attracting FDI, such as:

  • If a company manufactures any of the 348 essential drugs featuring in the National List of Essential Medicines (NLEM), the highest level of production of that drug in the last three years should be maintained for the next five years
  • The acquirer foreign company would not be allowed to close down the existing R&D centres and would require to mandatorily invest upto 25 per cent of the FDI in the new unit or R&D facility. The total investment as per the proposed condition would have to be incurred within 3 years of the acquisition.
  • Reduction of FDI cap to 49 per cent in rare or critical pharma verticals, as discussed above.
  • If there is any transfer of technology it must be immediately communicated to the administrative ministries and FIPB

Vaccines and cancer injectibles, which have a limited number of suppliers, could fall under the purview of even greater scrutiny.

Conclusion: 

The Ministries of Health and Commerce & Industries, which are in favor of restricting FDI in pharma stricter, are now facing stiff opposition from the Finance Ministry and the Planning Commission.

The Department of Industrial Policy and Promotion (DIPP) has now repotedly prepared a draft Cabinet Note after consulting the ministries of Finance, Pharma and Health, besides others. However, as comments from some ministries came rather late, the DIPP is reportedly moving a supplementary note on this subject.

The matter is likely to come up before the cabinet by end November/December 2013.

While FDI in pharma is much desirable, it is equally important to ensure that a right balance is maintained in India, where majority of the populations face a humongous challenge concerning access to affordable healthcare in general and affordable medicines in particular.

There is, therefore, an urgent need for critical assessment of tangible outcomes of all pharma FDIs in India as on date, based on meaningful parameters. This would help the Government while taking the final decision, either in favor of continuing with the liberalized FDI policy or modifying it as required, for the best interest of country.

Otherwise, without putting the hard facts, generated from India, on the table, is it not becoming yet another highly opinionated debate in its ilk, between  the mighty MNC pharma lobby groups either directly or indirectly, the Government albeit in discordant voices and other members of the society?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Are We Taking Safe and Effective Medicines?

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The above headline is in no way intended to mean that this discussion is on spurious or counterfeit drugs.

Today’s deliberation is on the licensed drugs, which are manufactured in India, for the patients of the country, by the manufacturers holding valid drug licenses from the Indian regulators.

Close on the heels of my article titled, “USFDA ‘Import Bans’: The Malady Calls For Strong Bitter Pills “, another equally serious incident related to drug safety, came to the fore.

Fabricated data from the Contract Manufacturer of large companies:

On November 12, 2013, the Drug Controller General of India (DCGI) was quoted saying that the investigative team of the drug regulator concluded that all the data submitted by Puducherry-based contract drug manufacturer GuruFcure, while seeking approval for manufacturing seven fixed dose combination drugs, are ‘fabricated’ and not ‘authentic’.

GuruFcure, which started operations in 2007 and calls itself “one of the leading pharmaceutical formulation manufacturers in India”, reportedly manufacture drugs for the leading pharma MNC and Indian companies and Indian companies such as:

  • Abbott
  • Alkem
  • Glenmark
  • Wockhardt
  • Unichem
  • Intas Pharma, among others.

Though, as per media report, Wockhardt and Glenmark said that these two companies are not currently associated with GuruFcure, the fact remains that they did market drugs produced by this contract manufacture in the past and the patients consumed those drugs against doctors’ precriptions.

 Large players need to set examples:

The largest pharmaceutical company in India with highest share of the Indian Pharmaceutical Market – Abbott, has also been reported to get some of their drugs manufactured by this contract manufacturer.

 Not a solitary example:

Just prior to this incident, in November 8, 2013, the DCGI reportedly ordered the Indian pharma major Sun Pharmaceuticals to suspend clinical research activities at its Mumbai based bio-analytical laboratory, after discovering that the company does not have the requisite approval from the central government for operating the laboratory. The DCGI has decided not to accept future applications and will not process existing new drug filings that Sun Pharma has made from the Mumbai laboratory until the company gets an approval.

Tardy regulatory system fuels apprehensions:

In India, many large, medium and small units get their products from the contract drug manufacturers. As compared to the USFDA inspection data, there are virtually no public data available on the details of inspections carried out at these plants by the drug regulators indicating the level of cGMP compliance.

Health being a state subject in India, State Drug Controllers should play a critical role in ensuring drug safety for patients through regular inspection of these manufacturing facilities on cGMP compliance.

Conclusion:

If cGMP violations can take place for drug exports, despite rigorous compliance checks by the foreign drug regulators, what could possibly happen when the same system is so tardy in India?

While the MNCs boast on their highest drug regulatory compliance standards, even for contract manufacturers, why do they keep relationships with those getting caught for fraudulent practices, is equally difficult to fathom.

One may possibly describe such incidents as just aberrations. However, that conclusion can only be drawn, when we have Drug Controllers’ cGMP inspection data for a large number of drug manufacturing units in India with details. Unfortunately, that is not the case, in any way.

In such an environment in India, the moot question that comes at the top of mind, “Are we taking safe and effective drugs, whenever required?”

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

USFDA ‘Import Bans’: The Malady Calls For Strong Bitter Pills

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It is a matter of pride that Indian pharmaceutical industry is the second largest exporter of drugs and pharmaceuticals globally, generating revenue of around US$ 13 billion in 2012 with a growth of 30 percent (Source: Pharmexcil).

Though sounds awkward, it is a reality that India is a country where ‘export quality’ attracts a premium. Unintentionally though, with this attitude, we indirectly accept that Indian product quality for domestic consumption is not as good.

‘Export quality’ being questioned seriously:

Unfortunately today, increasing number of even ‘export quality’ drug manufacturing units in India are being seriously questioned by the regulators of mainly United States (US) and the United Kingdom (UK) on the current Good Manufacturing Practices (cGMP) being followed by these companies. In many instances their inspections are culminating into ‘Import Bans’ by the respective countries to ensure dug safety for the patients.

Are drugs for domestic consumption safe?

Despite intense local and global furore on this subject, Indian drug regulators at the Central Drugs Standard Control Organization (CDSCO), very strangely, do not seem to be much concerned on this critical issue, at least, not just yet. Our drug regulators seem to act only when they are specifically directed by the Supreme Court of the country.

A recent major incident is yet another example to vindicate the point. In this case, according to media reports of November 2013, the Drug Controller General of India (DCGI) has ordered the Indian pharma major Sun Pharmaceuticals to suspend clinical research activities at its Mumbai based bio-analytical laboratory, after discovering that the company does not have the requisite approval from the central government for operating the laboratory. The DCGI has decided not to accept future applications and will not process existing new drug filings that Sun Pharma has made from the Mumbai laboratory until the company gets an approval.

Considering the blatant violations of cGMP standards that are increasingly coming to the fore related to ‘export quality’ of drugs in India, after inspections by the foreign drug regulators, one perhaps would shudder to think, what could possibly be the level of conformance to cGMP for the drugs manufactured in India solely for the local patients.

This question comes up as the record of scrutiny on adherence to cGMP by the Indian drug regulators is rather lackadaisical. The fact that no such warnings, as are being issued by the foreign regulators, came from their local counterpart, reinforces this doubt.

USFDA ‘Import Bans’:

Be that as it may, in this article let me deliberate on this particular drug regulatory issue as is being raised by the USFDA and others.

It is important to note that in 2013 till date, USFDA issued ‘Import Alerts/Bans’ against 20 manufacturing facilities of the Indian pharmaceutical exporters, sowing seeds of serious doubts about the overall drug manufacturing standards in India.

The sequence of events post USFDA inspection: 

Let us now very briefly deliberate on the different steps that are usually followed by the USFDA before the outcomes of the inspections culminate into ‘Import Alerts’ or bans.

After inspections, depending on the nature of findings, following steps are usually taken by the USFDA:

  • Issue of ‘Form 483’
  • The ‘Warning letter’
  • ‘Import Alert’

Revisiting the steps: 

Let me now quickly re-visit each of the above action steps of the USFDA.

‘Form 483’: 

At the conclusion of any USFDA inspection, if the inspecting team observes any conditions that in their judgment may constitute violations of the Food, Drug and Cosmetic (FD&C) and other related Acts, a Form 483 is issued to the concerned company, notifying the firm management of objectionable conditions found during inspection.

Companies are encouraged to respond to the Form 483 in writing with their corrective action plan and then implement those corrective measures expeditiously. USFDA considers all these information appropriately and then determines what further action, if any, is appropriate to protect public health in their country.

The ‘Warning Letter’:

The ‘Warning Letter’ is a document usually originating from the Form 483 observations and results from multiple lacking responses to Form 483 requiring quick attention and action. It may be noted that higher-level USFDA agency officials and not the investigator issue the ‘Warning Letters’.

‘Import Alert/ Ban’:

‘Import Alerts’ are issued whenever USFDA determines that it already has sufficient evidence to conclude that concerned products appear to be adulterated, misbranded, or unapproved. As a result, USFDA automatically detains these products at the border, costing the related companies a lot of money. The concerned company’s manufacturing unit remains on the import alert till it complies with USFDA cGMP.

What happens normally?

Most of the USFDA plant inspections are restricted to issue of Form 483 observations and the concerned company’s taking appropriate measures accordingly. However, at times, ‘Warning Letters’ are issued,  which are also mostly addressed by companies to the regulator’s satisfaction.

Import Bans are avoidable: 

Considering the above steps, it is worth noting that there is a significant window of opportunity available to any manufacturing facility to conform to the USFDA requirements by taking appropriate steps, as necessary, unless otherwise the practices are basically fraudulent in nature.

The concern:

Currently, there is a great concern in the country due to increasing frequency of ‘Import Alerts’.  As per USFDA data, in 2013 to date, about 20 drug manufacturing facilities across India attracted ‘Import Alerts’ as against seven from China, two each from Australian, Canadian and Japanese units and one each from South African and German facilities.

The matter assumes greater significance, as India is the second-largest supplier of pharmaceuticals to the United States. In 2012, pharmaceutical exports from India to the US reportedly rose 32 percent to US$ 4.2 billion. Today, India accounts for about 40 percent of generic and Over-The-Counter (OTC) drugs and 10 percent of finished dosages used in the US.

Ranbaxy cases: ‘Lying’ and ‘fraud’ allegations: 

In September 2013, after the latest USFDA action on the Mohali manufacturing facility of Ranbaxy, all three plants in India of the company that are dedicated to the US market have been barred from shipping drugs to the United States. The magnitude of this import ban reportedly impacts more than 40 percent of the company’s sales. However, Ranbaxy has a total of eight production facilities across India.

This ‘Import Alert’ was prompted by the inspection findings of the USFDA that the Mohali factory of Ranbaxy had not met with the cGMP.

Other two plants of Ranbaxy’s located at Dewas and Paonta Sahib faced the same import alerts in 2008, and are still barred from making drug shipments to the US.

The import ban on he Mohali manufacturing facility of Ranbaxy comes after the company pleaded guilty in May 2013 to the felony (criminal) charges in the US related to drug safety and agreed to pay a record US$ 500 million in fines.

In addition, the company also faced federal criminal charges that it sold batches of drugs that were improperly manufactured, stored and tested. Ranbaxy also admitted to lying to the USFDA about how it tested drugs at the above two Indian manufacturing facilities.

Heavy consequential damages with delayed launch of generic Diovan:

The ‘Import Alert’ of the USFDA against Mohali plant of Ranbaxy, has resulted in delayed introduction of a cheaper generic version of Diovan, the blockbuster antihypertensive drug of Novartis AG, after it went off patent.

It is worth noting that Ranbaxy had the exclusive right to sell a generic version of Diovan from September 21, 2012. 

Gain of Novartis:

This delay will help Novartis AG to generate an extra one-year’s sales for Diovan. This is expected to be around US$ 1 billion, only in the US. This development prompted Novartis in July this year to raise its profit and sales forecasts accordingly.

Wockhardt cases: Non-compliance of cGMP

Following Ranbaxy saga, USFDA inspection of Chikalthana plant of Wockhardt in Maharashtra detected major quality violations. Second time this year USFDA noted 16 violations of cGMP in the company’s facility. Earlier, in July 2013, the Agency issued a ‘Warning Letter’ and ‘Import Alert’ banning the products manufactured at the company’s Waluj pharmaceutical production facility.

Moreover, in September 2013, Medicines and Healthcare Products Regulatory Agency (MHRA) had pulled the GMP certificate of the company’s unit based in Nani Daman, after an inspection conducted by the UK regulator showed poor manufacturing standards. 

Again, in October 2013, the MHRA withdrew its cGMP certificate for the Chikalthana plant of Wockhardt. This move would ban import of drugs into the UK, manufactured in this particular plant of the company.

However, MHRA has now decided to issue a restricted certificate, meaning Wockhardt will be able to supply only “critical” products from these facilities. This was reportedly done, as the UK health regulator wants to avert shortage of certain drugs essential for maintaining public health. The impact of the withdrawal of cGMP certificate on existing business of the company can only be ascertained once Wockhardt receives further communications from the MHRA.

Earlier in July 2013, MHRA had reportedly also imposed an import alert on the company’s plant at Waluj in Maharashtra and issued a precautionary recall for sixteen medicines made in this unit.

RPG Life Sciences cases: allegedly ‘Adulterated’ products: 

In June 2013, USFDA reportedly issued a ‘Warning Letter’ to RPG Life Sciences for serious violation of cGMP in their manufacturing plants located at Ankleshwar and Navi Mumbai.

USFDA investigators had mentioned that “These violations cause your Active Pharmaceutical Ingredients (APIs) and drug products to be adulterated …the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with cGMP.”

Strides Arcolab case: Non Compliance of cGMP

In September 2013, Strides Arcolab announced that its sterile injectable drug unit – Agila Specialties (now with Mylan) had received a warning letter from the USFDA after its inspection by the regulator in June 2013. However, Strides Arcolab management said, “the company was committed to work collaboratively and expeditiously with the USFDA to resolve concerns cited in the warning letter in the shortest possible time.”

USV case: allegation of ‘data fudging’: 

Recently, USFDA reportedly accused Mumbai-based drug major USV of fudging the data.

After an inspection of USV’s Mumbai laboratory in June 2013, the US drug regulator said the company’s “drug product test method validation data is falsified”. The USFDA has also reprimanded USV for not training its staff in cGMP.

Probable consequences: 

USFDA import bans and a similar measure by the UKMHRA would lead to the following consequences:

  • Significant revenue losses by the companies involved, till the concerned regulators accept their remedial actions related to cGMP.
  • Increasing global apprehensions about the quality of Indian drugs.
  • Possibility of other foreign drug regulators tightening their belts to be absolutely sure about cGMP followed by the Indian drug manufacturers, making drug exports from India more difficult.
  • Huge opportunity cost for not being able to take advantage from ‘first to launch’ generic versions of off patent blockbuster drugs, such as from Diovan of Novartis AG.
  • Indian patients, including doctors and hospitals, may also become apprehensive about the general quality of drugs made by Indian Pharma Industry, as has already happened in a smaller dimension in the past.
  • Opposition groups of Indian Pharma may use this opportunity to further their vested interests and try to marginalize the Indian drug exporters. 
  • MNCs operating in India could indirectly campaign on such drug quality issues to reap a rich harvest out of the prevailing situation.
  • Unfounded ‘foreign conspiracy theory’ may start gaining ground, prompting the Indian companies moaning much, rather than taking tangible remedial measures on the ground to effectively come out of this self created mess.

Conclusion: 

Repeated cGMP violations made by the Indian drug exporters, as enunciated by the USFDA, have now become a malady, as it were. This can be corrected, only if the reality is accepted without attempting for justifications and then swallowing strong bitter pills, sooner.

Thereafter, the domestic pharma industry, which has globally demonstrated its proven capability of manufacturing quality medicines at affordable prices for a large number of patients around the world and for a long time, will require to tighten belts for strict conformance to cGMP norms, as prescribed by the regulators. This will require great tenacity and unrelenting mindset of the Indian Pharma to tide over the crisis.

Any attempt to trivialize the situation, as indicated above, could meet with grave consequences, jeopardizing the thriving pharma exports business of India.

That said, any fraud or negligence in the drug quality standards, for whatever reasons or wherever these may take place, should be considered as fraud on patients and the perpetrators must be brought to justice forthwith by the DCGI, with exemplary punitive measures.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

In VUCA World: Changing Dynamics of Prescription Generation Process

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The acronym VUCA is often being used to emphasize upon the Volatility, Uncertainty, Complexity and Ambiguity in various situations. The term has been derived from military vocabulary and is being used since 1990s in the business management parlance. VUCA is also considered as a practical code for awareness and readiness.

I find all the elements of VUCA playing an active role in the prescription demand generation space too, as it is based on various assumptions of what will work and what won’t in a fast changing pharmaceuticals business environment. 

The interplay:

Primary interplay in the sustainable prescription demand generation process of today’s digitally empowered VUCA environment, I reckon, could be as follows:

  • Volatility: Fast changing dynamics of medical communication with interfaces made of emerging modern technological tools carrying high risks of rapid obsolescence.
  • Uncertainty: Lack of predictability in assessing outcomes of increasingly expensive product detailing inputs, coupled with too many surprise elements popping-up in the environment almost from nowhere and more frequently.
  • Complexity: Multi-factorial Doctor-Medical Representative (MR) interactions, which get even more complicated with increasing time constraints for effective product detailing to take place.
  • Ambiguity: Difficult to fathom changing needs of the doctors/payors, leading to increasing cause-and-effect confusion by the pharma marketing strategy planners.

Keeping these in view, today I shall deliberate on the ‘Criticality of Optimal Mix of Human and State of Art Digital Interfaces’ for sustainable prescription demand generation in a VUCA environment.

The key influencer – a new study:

A research study published in June 2013, in the ‘American Heart Journal (AHJ)’ establishes that the interaction between physicians and MRs, though essential for  improvement of medical care, is indeed complex. This is mainly because of the apprehension that conflict of interests may affect the doctors’ prescription decision-making process. 

However, the fact comes out, the doctors tend to prescribe more of expensive medical products after interacting with MRs from the concerned manufacturing companies, which, in turn, raises the treatment costs for patients.

Study established MRs influence prescription decision:

This particular AHJ study compared the use of Bare-Metal Stents, Drug-Eluting Stents (DES), and Balloon Catheters according to company presence in the hospital. It concluded that MR presence was associated with increased use of the concerned company’s stents during percutaneous coronary interventions. The effect was more pronounced on the use of DES, and resulted in higher procedural cost of US$ 250 per patient.

In this particular study, it was found that DESs were used in about 56 percent of the cases, when the MRs concerned were at the hospital, against 51 percent when they weren’t there.

Interestingly on such interactions between the MRs and the drug/devices industry two opposite viewpoints emerge.

‘MR-Doctor interaction important‘ – Industry:

Quoting the Associate General Counsel and Director of Legal and Medical Affairs at the Advanced Medical Technology Association, a medical technology trade association, Reuters reported, “interactions between sales representatives and doctors benefit patients and are supported by professional medical organizations.”

‘MR interaction should not influence prescription decision’ – Doctors:

In the same report, the study’s lead author was quoted saying, “We need to evaluate carefully any interactions with medical industry to ensure that we minimize an effect on our decision making process.”

The bottom-line, though the debate continues:

This debate will keep continuing even in the years ahead. Be that as it may, the key fact that emerges out of the above study is, MRs do play a critical role in the prescription decision-making process of the doctors, especially for expensive medical products . Consequently, the pharmaceutical companies will prefer maintaining such ‘influencing’ roles of MRs to boost revenues of their respective brands.

This process assumes even greater importance in a VUCA world, as situation specific more frequent human interventions, strongly backed by state of art technological supports, would need to be effectively deployed for generation of sustainable prescription demand to excel in business.

The X-Factor:

However, one of the most challenging issues even in a VUCA situation is that pharma players continue and will continue to target the same sets of prolific prescribers for any given class of products in pursuit of success. As a result, time being so limited, very often even after waiting for hours MRs may not be able to meet the key prescribers.

Moreover, as and when the meeting takes place, it may well get restricted to just a very brief discussion due to the X Factor – paucity of the doctors’ time. Thus, delivering an effective product message in such a short time becomes increasingly challenging. Further, the difficulty in arresting un-interrupted attention of the busy practitioners due to X-Factor when they are with patients, compounds the problem.

Pivotal role of state of art technological tools:

The effectiveness of connection between respective brands of different drug makers and the doctors can be greatly facilitated with the application of state of art technology and modern internet based tools in varying proportions, as the sales and marketing communication strategy would dictate.

This area is emerging as a crafty game, which calls for wide-scale application of analytics.

Traditional strategies not enough:

In a VUCA world, while traditional face-to-face product detailing to doctors may continue to be the primary means for prescription demand generation, experimentation with a good number of new Internet based initiatives has already been started, as I discussed in my earlier article.

Hence, the concepts of digital marketing and e-detailing are gaining ground fast. Such initiatives of augmented digital communication of key marketing messages to doctors, would also help driving the key customers’ traffic to respective product Websites of the concerned companies for more detailed and convincing medical treatment solutions, as and when required by the busy doctors.

Types of digital interventions:

These digital interventions may include:

  • Highly targeted brand specific e-mailing responding to pre-identified needs of individual doctors
  • Sample ordering as per requirements of doctors
  • Live online product presentations at a time convenient to individual doctors
  • Quick and need-based problem solution centric online chats 24×7
  • Strategic usage of social media, backed by a robust pre-decided key output measuring matrix

However, the mix of each of these digital applications will need to be carefully worked out as robust supporting measures to key prescription demand generation activities, spearheaded by the MRs. 

MRs to remain as ‘Spearheads’:

In my view, MRs would still remain the frontline force in the emerging world (dis)order, may be lesser in number, for sustainable prescription demand generation process. Therefore, there is an urgent need to take them on board upfront and train suitably to make the modern digital interfaces successful as powerful differentiating support tools.

Technology based training on digital marketing and e-detailing as empowering initiatives, demonstrating tangible benefits that such high tech-interventions can offer in the overall sales performance of MRs, would play a critical role. Such efforts would, in turn, immensely help making digital augmentation strategies for pharma detailing successful, in the long run.

MR involvement is critical:

In my view, to be successful in a VUCA environment with all these endeavors, however tech-intensives those may be, there will be a critical need to make the MRs understand and learn the process. In tandem, it is equally important to actively engage them in the execution of the integrated medical communication strategy of the concerned companies.

Keeping this perspective in mind, I guess, it will be quite apt to quote Ben Franklyn, one of the Founding Fathers of the United States and a leading author, printer, political theorist, politician, scientist, musician, inventor and economist, all in one, who once wrote:

“Tell me and I forget, 

 Teach me and I remember,

 Involve me and I learn”

Thus, MRs would continue to have a critical role to play in the demand generation process for prescription medicines. However, they must be properly trained to be able to provide the types of knowledge and information that the doctors may not have ready access from elsewhere.

The entire process would, at the same time, require massive technological interventions, not incremental in nature but radical in scope and dimensions, and at a much wider scale than what we have been attempting today.

Challenges in India:

The very concept of VUCA in the changing dynamics of sustainable prescription demand generation, brings to the fore the issue of quality of MRs in India.

Currently there is a wide, both inter and intra company, variation in the educational qualifications, relevant product and disease area knowledge, professional conduct and ethical standards between MRs in our country.

Employability of MR in a VUCA world:

Just when we talk about augmented digital interfaces in medical communications, there exists a huge challenge in the country to strike a right balance between the level/quality of sales pitch generated by the MRs for a brand.

At times, many of them may not be properly armed with requisite scientific knowledge, and the basic norms of professional conduct/ ethical standards, while rendering their services.

They may not also be able to handle the sophisticated technological tools with quick application of minds. Hence, the subject of employability of MR in a VUCA world needs to be addressed afresh in India.

‘One size fits all’ strategies:

To make it happen, the pharmaceutical players would require to jettison, ‘one size fits all’ types of strategies in a VUCA world.

In tandem, pharma marketing strategists will need to be intimately conversant with a relatively difficult process of cerebral gymnastics to help formulating individual key prescriber-centric communication strategies, where MRs can play a key role with optimal digital interventions.

This is possible, if supported by the respective employers creating an environment of empowerment, backed by requisite product training, technological tools, modern behavioral inputs and above all by making investments to create of a large sustainable emotional capital for longer term  business excellence.

Conclusion:

All the elements of VUCA would keep playing very critical roles in sustainable prescription demand generation process in the years to come, more than ever before.

There is a critical need to understand the interplay between each of these dynamics on an ongoing basis to make strategic modifications quickly, whenever required. This is important, as the prowess to introduce right changes at right times will differentiate men from the boys in this ultimate ball game of the pharma industry. 

To succeed in a VUCA environment, pharmaceutical companies may choose to predominantly focus on harnessing their technological expertise. 

However, to face the waves of virtually unpredictable continuous change, only technology based efforts, I reckon, are less likely to fructify. Unless, these high- tech interventions are spearheaded by time-specific fast enough and intelligent skilled human responses in form of MRs. 

Having said that, it would be foolhardy to even think of completely taming VUCA with whatever human and technological wherewithal that any pharma player may be able to garner to achieve its goals. It is, in fact, a matter of relativity in managing VUCA in a given situation at a given time. 

Thus I believe, there is, on the contrary, a need to leverage a VUCA environment, for creation of an ‘Optimal Mix of Human and State of Art Digital Interfaces’ in the product detailing process with a high sense of urgency. This would be critical to gain cutting edge advantages for generation of increased prescription demand in a sustainable way.

For the pharmaceutical marketing strategists, this new ball game would obviously not be a piece of cake either, as the key success factors would involve the right mindset of first unlearning and then relearning the process on an ongoing basis, virtually in all time to come

With this perspective, I conclude by quoting the famous American writer and futurist Alvin Toffler, who once said,

“The illiterate of the 21st century will not be those who cannot read and write, but those who cannot learn, unlearn, and relearn.”

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Big Pharma Demands Transparency, Keeping their ‘Black-Boxes’ Tight and Safe?

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Pharmaceutical Industry across the globe wants absolute transparency in all government laws, policies, guidelines, transactions and overall governance. They also expect the trade environment should be predictable, non-manipulative and business-friendly. These expectations are indeed well justified and deserve whole-hearted support from all concerned.

However, when similar expectations of transparency are voiced by stakeholders in the Big Pharma business operations, that will have direct or indirect impact on public health interests, one would mostly encounter a well guarded, mammoth and impregnable ‘Black Box’, wearing a ‘Top Secret’ label, with all relevant information kept inside.

Such areas of stakeholders’ interests on Big Pharma could well be related to details, like for example:

  • Actual break-up of R&D expense details,
  • Transparency in all clinical trials data for experts review,
  • Patented products’ pricing rationale,
  • Enormous total costs of lobbying and related expenses at the global level,
  • Marketing spend on doctors and other decision makers, directly or indirectly, just to name a few.

Mounting curiosity:

Continuation of such opaque practices for a long time, in turn, sparks the curiosity of the intelligentsia to know more in details, especially, about the areas as stated above.

Various research studies are now coming up, with huge revelations and strong findings in these areas. All of these together indicate, it is about time for the global pharma to also demonstrate transparency in their respective business practices and corporate governances, without further delay.

If it does not happen, probably respective governments in various countries will start acting on these areas of opaque self-serving pharma business practices, with the enactment and more importantly, stricter enforcement of requisite laws and policies. President Obama Administration in the United States has already initiated some important actions in these areas with proposals and laws, like for example,  the “Physicians Payment Sunshine Act’ .

The ‘Power Game’:

An interesting article of May 3, 2013 highlighted that the global pharmaceutical industry exerts incredible influence over the prescription medicines across the globe. This power, as many will know, flows from robust political contacts and influences over various important government agencies administrating the entire healthcare system, executed immaculately by expensive lobbying and PR campaigns by their globally integrated trade bodies.

Similar powerful influences also get extended to doctors and the people who matter to further their interests. These well crafted plans are reportedly executed through sponsored or paid opinion-modifying articles, ‘advertorials’, DTC advertisements (wherever legally permitted) and well-organized, seemingly third party, speeches to push the envelopes further.

Most probably, keeping such ongoing practices in mind and coming under intense media pressure, the Medical Council of India (MCI) on December 10, 2009 amended the “Indian Medical Council (Professional Conduct, Etiquette and Ethics), Regulations 2002″ for the doctors in India. Unfortunately, its implementation on the ground is rather tardy.

The above article also stated, “In fact, in the United States the industry contributes heavily to the annual budget of the U.S. Food and Drug Administration (FDA), which is charged with regulating drugs and devices made by those same companies.”

Avoidable Expenditures:

The paper indicates that in the United States alone the industry associations:

  • Have 1,100-plus paid lobbyists on Capitol Hill,
  • Allocated US$ 188 million annual lobbying budget
  • Doles out around US$ 14 million to political candidates every year

The report also comments, ‘Drug companies spend substantially more on marketing than they do on research and development.’

Influencing opinion against patients’ interest?

The article in the ‘drugwatch’ also states:

“Doctors are persuaded by the pharma companies to attach their names (ghost writing), against financial considerations, to favorable article on a particular drug ensuring that it is published in a well reputable medical journal.”

The author continues that ‘Ghost writings’ are being used to promote numerous drugs to influence concerned stakeholders.

In 1998, a study of the prestigious New England Journal of Medicine found that ‘out of 75 published articles, nearly half were written by authors with financial conflicts. And, worse than this, only two of the articles disclosed interests.’

Richard Smith, former editor of the British Medical Journal, was quoted saying, “All journals are bought – or at least cleverly used – by the pharmaceutical industry.”

Striking facts:

Following are some striking facts as reported in the article, as mentioned above:

“Advertising instead of research: For every US$ 1 spent on “basic research,” Big Pharma spends US$ 19 on promotions and advertising.

Distribution of free drug samples: The United States has 1 pharmaceutical sales representative for every 5 office-based physicians.

Sponsorship of symposiums and medical conventions: Drug and medical device makers spend lavishly on doctors, including covering meals, travel, seminars and conventions that may look more like vacations.”

Pressure on publications:

The paper highlights that large global pharma majors may even pull its advertisements out, if the concerned medical journal will question the accuracy of an ad. Such types of threats have very serious effects on these journals in running their businesses without getting lucrative advertisement dollars from the drug manufacturers.

Making drugs looking good:

The same article highlights:

“Quite often the academics and scientists are hired hands who supply human subjects and collect data according to the instructions from their corporate employers. Sponsors keep the data, analyze, write the papers and decide whether and when and where to submit them for publication. Drug companies have discovered ways to stage-manage trials to produce predetermined outcomes that will put their products in the best light.”

With this strategy even a bad drug can allegedly be made looking good by doing many things, like for example:

  • Comparing them to a placebo
  • Comparing them to a competitor’s medication in the wrong strength
  • Pairing them with a drug that is known to work well
  • Shortening a trial before any bad results surface
  • Testing in groups too small to provide valid evidence

Pay-for-delay deals:

A recent report titled, “Top twenty pay-for-delay drugs: How Industry pay-off delay generics” highlights that ‘Pay-for-delay deals’ have forced patients in the United States to pay an average of 10 times more than necessary for at least 20 blockbuster drugs.

Key findings of the analysis on the impact of pay-for-delay deals are as follows:

  • This practice has held back generic medicines used by patients with a wide range of serious or chronic conditions, ranging from cancer and heart disease, to depression and bacterial infection.
  • These payoffs have delayed generic drugs for five years, on average, and as long as nine years.
  • These brand-name drugs cost 10 times more than their generic equivalents, on average, and as much as 33 times more.
  • These patented drug companies have made an estimated US$ 98 billion in total sales of these drugs while the generic versions were delayed.

Citing example, the paper says, a pay-for-delay deal kept a generic version of the breast cancer drug Tamoxifen off the US market for nine years, while Pfizer made $7.4 billion in sales of its cholesterol-lowering drug Lipitor (atorvastatin) in 2012 alone.

The point to ponder yet again is, why such practices are being surreptitiously carried out for years sacrificing patients’ interest and without the regulators’ strong interventions, in general?

French Government has initiated a probe:

The French Competition Authority is reportedly expected to publish a report on the findings of its inquiry, initiated in February 2013, into the costs and pricing of medicines in France. The report will also look at whether industry practices are interfering with the market entry of generic drugs, including distribution arrangements between drug manufacturers, wholesalers and pharmacists.

An appreciable initiative in America, but why not in India?

There is still a simmering hope. As indicated above, President Obama’s Affordable Care Act reportedly requires that from September 2013, pharmaceutical companies will need to collect data and openly report information on payments, investment interests, ownership and items of value given to doctors and hospitals. Very unfortunately, the Department of Pharmaceuticals of the Government of India has not taken any such steps, as yet, despite the situation turning grave in the country.

The power of pharma lobby in the US:

According to a recent NYT report, in the United States, government health programs are forbidden from rejecting new drugs on cost grounds.

When the issue of drug prices came up as part of President Obama’s ‘Affordable Care Act’ debate, it was summarily rejected in Congress. Simultaneously, a move toward comparative-effectiveness studies, putting rival drugs or treatments through trials to determine which work better, was also decried.

The report highlights, the mere suggestion of the US government throwing its weight around on drug prices stirs up talk of ‘socialism’. The pharma lobby doesn’t have to look far for support in fighting that idea. In the US, the so-called ‘free market’ is trusted to regulate drug prices, despite the reality that the healthcare market is far from transparent, ‘with byzantine pricing mechanisms and costs that vary wildly region-by-region, pharmacy by pharmacy and even patient-by-patient’.

The usual supply/demand/pricing relationships do not apply to drug prices at the consumer level in the US too, just as it has been proved in India. 

A large part of creation of this environment is attributed to pharmaceutical and other health-products firms, who reportedly spent a total of US$ 250 million on lobbying last year. 

Big Pharma keeps failing credibility tests:

This happened very recently, when The Guardian in July 2013 reported, the pharmaceutical industry has “mobilized” an army of patient groups to lobby against plans to force companies to publish secret documents on drug trials. This is related to the news that the European Medicines Agency (EMA) could force drug companies to publish all Clinical Trial (CT) results in a public database.

The above report says, while some pharma players agreed to share data, important global pharma industry associations have resisted this plan of the EMA. The report continues, a leaked letter from two large pharma trade associations, the Pharmaceutical Research and Manufacturers of America (PhRMA) of the United States and the European Federation of Pharmaceutical Industries and Associations (EFPIA), have drawn out a strategy to combat calls by drug regulators to force companies to publish all CT results.

The strategy reportedly shows how patient groups, many of which receive some or all of their funding from drugs companies, have been drawn into this battle by these Big Pharma lobby groups.

The e-mail reportedly seen by ‘The Guardian’ was from Richard Bergström, Director General of EFPIA, addressed to directors and legal counsel at Roche, Merck, Pfizer, GSK, AstraZeneca, Eli Lilly, Novartis and many smaller companies.

The e-mail leaked by an employee of a pharma company describes a four-pronged campaign that starts with “mobilizing patient groups to express concern about the risk to public health by non-scientific re-use of data”.

Translated, as ‘The Guardian’ reported, “that means patient groups go into bat for the industry by raising fears that if full results from drug trials are published, the information might be misinterpreted and cause a health scare.”

This appears to be another classic case of vested interests working against patients’ interests.

Global lobbying started taking the center stage in India too:

With the above back-drop and lobbying scandals reportedly being surfaced in many other countries, it is about time that India puts its acts together with India-specific stricter disclosure policies, including R&D, Clinical Trials (CTs), Patented Products Pricing, Marketing Practices and Trade Lobbying.

Interestingly, to influence Government policies India’s top lobbying spenders in 2012 (US$ million) were reported as follows:

1 US Chamber of Commerce

136.3
2 National Association of Realtors

41.5
3 Blue Cross / Blue Shield

22.5
4 General Electric

21.1
5 American Hospital Association

19.2
6 National Cable & Telecom. Association

18.9
7 Pharmaceutical Research & Mfrs. of America (PhRMA)

18.5
8 Google

18.2
9 Northrop Grumman

17.5
10 AT&T

17.4
11 American Medical Association

16.5
12 Boeing

15.6

Source: The Center for Responsive Politics (Economic Times, June 4, 2013)

According to the latest lobbying disclosure reports filed with the US Senate and the House of Representatives, at least two dozen American companies and industry associations are reportedly lobbying hard with the US lawmakers on issues in India, which include:

  • Intellectual Property (IP)
  • Patent
  • Market access

Another recent report comments as follows:

“The US Chamber of Commerce has become a portal for dubious reports that claim India’s intellectual property regime is worse than China’s. Such “research” by paid lobbyists and disseminated through the halls of US Congress…”

Hefty fines for illegal practices, yet Black Box remains tight and safe: 

In December 2010, Healthcare advocacy group Public Citizen published a report that, for the first time, documented all major financial settlements and court judgments between pharmaceutical manufacturers and the federal and state governments of the United States since 1991.

It says, almost US$ 20 billion was paid out by the pharmaceutical industry to settle allegations of numerous violations, including illegal, off-label marketing and the deliberate overcharging of taxpayer-funded health programs, such as Medicare and Medicaid.

Three-fourths of the settlements and accompanying financial penalties had occurred in just the five-year period prior to 2010. There has been no indication that this upward trend is subsiding.

10 Largest Settlements and Judgments on Big Pharma mis governance:
(Period: Nov. 2, 1010 – July 18, 2012)

Company Amount    US$ Million Year Reasons
1. GlaxoSmithKline 3, 000 2012 Unlawful promotion, kickbacks, concealing study data, overcharging government health programs
2. Abbott  1,500 2012 Unlawful promotion, kickbacks
3. Johnson & Johnson 1,200 2012 Unlawful promotion
4.  Merck 950 2011 Unlawful promotion
5. Ranbaxy 500 2012 Poor manufacturing practices, falsifying data on FDA applications.
6. Johnson & Johnson 327 2011 Unlawful promotion
7. Boehringer Ingelheim 280 2011 Overcharging government health programs
8. Mylan’s Dey Pharma unit 280 2010 Overcharging government health programs
9. Elan 203 2010 Unlawful promotion, kickbacks
10. Johnson & Johnson 158 2012 Unlawful promotion

Conclusion:

All such expenditures, including expensive lobbying and court settlement charges for illegal business practices, as mentioned above, I reckon, are wasteful and avoidable. These are mostly outcomes of self serving measures, shorn of public health interest, 

If all these costs are eliminated and actual R&D expenses are reflected, in a transparent manner, there could be significant reduction in the costs of newer innovative drugs, extending their access to billions of patients, across the world.

Thus to help evaluating the innovative drugs with greater transparency, there is an urgent need for the Big Pharma to set examples by voluntarily disclosing the secrets hidden within the ‘Black Boxes’, as deliberated above. These disclosures should be made to the independent experts and the respective Governments under appropriate statutes.

Expectations of transparency in Governance should not, therefore, be restricted just to Government laws, policies and decisions, the industry should reciprocate it too, in equal measures.

To be patient-centric, transparency in governance needs to be a two-way traffic, where pharma industry should volunteer to be an integral part, sooner than later. Otherwise it may be too late for them to avoid harsh interventions of the respective regulators, as the intense pressure from intelligentsia, civil society and media, keep mounting.

That said, the question lingers:

When the ‘Big Pharma is rightly demanding transparency in all areas of public discourse, why are they so reluctant in making their intriguing ‘Black Boxes’ transparent, that too only in areas of public health interest, for fair experts review?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Drug, Patent and Hype: Quo Vadis Pharma Innovation?

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A recent research report reveals, though the pharmaceutical companies in the United States since mid 2000 have spent over US$ 50 billion every year to discover new drugs, they have very rarely been able to invent something, which can be called significant improvement over already existing ones.

As per available reports, from the year 2000  to 2010, the US-FDA, on an average, approved just 24 new drugs per year. This number is a sharp decline from the same of 1990, when on an average 31 new drugs were approved per year.

These studies throw open some important questions to ponder:

  • What is then the real issue with pharma innovation? 
  • Is it declining quality or quantity (number)?
  • What impacts the patients more?

Quantity vs quality of innovation:

A recent paper explored whether declining numbers of New Molecular Entities (NMEs), approved in the United States (US) each year, is the best measure of pharmaceutical “innovation.”

Thus, studying in detail the NME approvals in the US during 1987 to 2011, the authors proposed the following three distinct subcategories of NMEs:

  • First-in-class
  • Advance-in-class
  • Addition-to-class

This classification was aimed at providing more nuanced and informative insights into underlying trends.

The paper established that trends in NME approvals were largely driven by ‘Addition-to-class’, or “Me too,” drug approvals. However, the good news is that ‘First-in-class’ approvals remained fairly steady over the study period.

Thus I reckon, there should be much greater focus with higher resource deployments for  more of ‘First-in-class’ drugs research and development.

To achieve this objective with requisite wherewithal, there will be a need to drastically cut down massive R&D expenditures on “Me-too” types of so called ‘innovative’ drugs. Such drugs, carrying exorbitant price tags,  creating a financial burden to the payers, could perhaps help increasing the number of innovations, but certainly not the quality of innovations to meet important unmet needs of patients in a cost effective manner.

Some facts: 

In 2010, the healthcare journal Prescire rated 97 new drugs or new indications. Only 4 of these provided any therapeutic advantage over the available existing drugs. Interestingly, 19 others (1 in 5) were approved despite having more harms than benefits.

According to another analysis, “About 1 in 6 new products had more harms than benefits, while more than half of all new products provided no advantages over existing options.”

Further, a different article published in Nature Reviews indicated, “doctors were more likely to rate drugs more than a decade old as transformative.”

Decline in the quality of innovation:

In this context, Dr Mark Olfson of Columbia University and statistician Steven Marcus of the University of Pennsylvania have reportedly established as follows:

“By the 1980s new drugs were less than four times better; by the 1990s, twice as good, and by the 2000s just 36 percent better than a placebo. Since older drugs were much superior to placebo and newer ones only slightly so, that means older drugs were generally more effective than newer ones.”

While even in earlier years, newer patented drugs on an average used to be 4.5 times more effective, as compared to placebo.

The winds of change?

As a result, under the new ‘Affordable Care Act’ of President Obama, “comparative effectiveness research” by an independent research institute could well conclude that older drugs or even cheaper generic equivalents are better than the high priced patented ones, which create fortunes for the innovator pharmaceutical companies at the cost of patients and payers.    

The above initiate in ‘Obamacare’, if and when fructifies, will indeed hit the ‘Me-too’ type of drug innovators, especially in the United States, very hard. Nevertheless, is a music to the ear for the private health insurance companies and the patients at large.

A ray of hope?

‘Comparative drug effectiveness analysis’, as stated above, could eventually lead to replacement of newer high priced ‘me-too’ patented drugs by older relatively low priced generic equivalents, at least, for reimbursements.

This will, no doubt, lead to huge profit erosion of the big pharmaceutical players. Hence, extensive lobbying by industry groups in top gear, against this ‘patient-centric’ proposal, is currently on, .

As the new federal healthcare law will find its roots in America, despite strong opposition  from the powerful and influential pharma lobby groups, a ray of hope is now  faintly seen in otherwise blatantly exploitative and rather cruel drug pricing environment.

Where hype is the key driver:

Despite enormous hype, being created and spearheaded by the Big pharma, on the ‘essentiality’ of most stringent Intellectual Property Rights (IPR) regime in a country with patent laws blatantly in favor of commercial considerations, to enjoy a monopolistic marketing climate with pricing freedom, breakthrough pharma innovations are now indeed rather difficult to come by, as we shall deliberate below.

Reasons for decline:

Many experts believe that the following reasons, among many others, have attributed to the decline in the quality of pharmaceutical R&D output:

  • Most important drug discoveries for mankind have already been made or in other words, the low hanging fruits of pharma R&D have already been plucked. Now not so easy and rather difficult drug targets are remaining.
  • In the last decade, most of pharma R&D efforts were reportedly concentrated mainly in four major disease areas: central nervous system, cancer, cardiovascular and infectious diseases.
  • There is a need now to focus more on poorly understood and more complex therapeutic areas such as, autoimmune diseases or complex diseases related  immune system of the body, to meet greater unmet needs of patients.
  • Clinical trial volunteers are now more difficult to recruit and treat.
  • More stringent regulatory requirements for clinical trials with studies using much larger number of patients, making the clinical drug development process very expensive.

Could it be worse for Big Pharma?

The evolving situation, though very early in the day now, has the potential to turn much worse for the big pharma and good for the patients, if some key changes take place.

Many industry analysts, across the world, feel that ‘liberal’ patent laws are responsible for acceptance of minor advances over the existing products as patentable with 20 years of market exclusivity.

Thereafter, another ‘liberal’ minded drug regulatory framework allows the pharma players to market such ‘not-so-innovative patented medicines’ aggressively, enabling them to amass astronomical profits in no time at the cost of patients’ interests and payors’ financial burden , as happened in the United States and many other countries recently.

To avoid such trivial innovations the law and policy makers in the industrialized countries may well ponder as follows:

1. Align the country’s ‘Patents Act’ with similar to what Indian law makers had formulated in 2005 to avoid minor and ‘evergreening’ types of patents under section 3(d) of the Act.

2. The clinical research data must establish that the new drugs offer significantly more tangible benefits to the patients than the existing ones.

Denial of patentability for ‘me-too’ innovations and their subsequent regulatory approvals would significantly reduce the drug treatment cost with virtually no adverse impacts on patients, across the world.

If such measures are taken by the developed countries of the world and also the emerging markets, the Big Pharma would be compelled to change their respective business models, making ailing patients of varying financial status, color and creed central to their respective strategic ideation processes.

Otherwise, it is highly unlikely that anything will change for the patients from what we are all experiencing today, at least in the near to medium term.

A possible pathway:

Highly conflicting interests of Big pharma and the patients, should get resolved sooner than later and that again for the interest of both. 

Thus, to find a meaningful and generally acceptable solution to this issue, there is a dire need for a much wider global debate. The deliberations, at the same time, should include possibilities of finding ways to avoid huge wasteful expenditures on pharmaceutical R&D for developing new products that offer no significant benefits to the patients over the existing ones. On the contrary, such products burden them with exorbitant incremental drug treatment costs, 

The motions of the debate could well be in the following lines:

1.  ‘Should United States amend its patent laws by categorically stating that a mere “discovery” of a “new form” of a “known substance” that does not have properties resulting in significant improvement in clinical efficacy, will not be patentable?

2. Shouldn’t the clinical research data must always establish that the new drugs offer significantly more tangible benefits to the patients than already available cheaper equivalents?

The positive outcome of this global debate, if fructifies, will indeed be considered as a paradigm shift in the new world order for all, hopefully.

Unfathomable reluctance: 

Despite all these developments, a recent report indicated that the heads of seventeen industry associations of the United States wrote a letter to President Obama complaining, among others, India’s patents regime. This includes the most powerful, yet equally controversial, pharmaceutical lobby group of America.

The letter alleged that the recent policy decisions in India undermine internationally recognized Intellectual Property (IP) standards, which are “jeopardizing domestic jobs” in America and are unacceptable to them.

Though the details of issues were not highlighted in the letter, One concern it specifically expressed that the defeat of Novartis on the Glivec case that challenged Section 3(d) of the Patents Act of India has raised the bar on what can be considered a true innovation for the grant of patent in India.

Though this judgment of the apex court of India was widely acclaimed even globally, American Trade Association Lobby Groups seem to project exactly the opposite, reportedly, driven solely by profit motives of their members and shorn of patients’ interests

Interestingly, an article published in The New England Journal of Medicine, July 17, 2013 also states as follows:

“A patent law that treats incremental innovation and significant innovation in the same way, encourages companies to prioritize less important research over more important research.”

A diametrically opposite viewpoint:

Another school of thought leaders opine, ‘me too’ innovations will continue to remain alive and well. This will happen, even if such new products are starved of oxygen by ‘the tightening purse strings of the eventual customers’. These innovations are sustained by the stronger imperative to avoid clinical failures and to play relatively safe in the space of expensive R&D investments.

They feel that pharma players will continue to focus on to leaner drug discovery and development models to have healthier late-stage product pipelines of such types.  In tandem, by cutting costs even more aggressively, as we witness today, they will find space to keep the level of risk optimal for delivering real innovation, when the time comes.

This type of business model, the experts feel is based on the belief that it is far better to acquire a product with very little innovation ensuring that it can hardly fail to be approved by the regulator. Thereafter, the concerned players may figure out ways of how payors will actually pay for it, rather than focusing primarily on acquiring a genuinely innovative ‘First-in-class’ product and then discover it has ‘feet of clay’.

For example, AstraZeneca reportedly invested a little over US$1 billion in two such products in one month: another LABA combination from Pearl Therapeutics and a prescription ‘Fish Oil’ capsule from Omthera Pharmaceuticals.

Conclusion:

Be that as it may, a large number of experts do opine, especially in the light of the above letter of the American Trade Associations that the verdict of the Honorable Supreme Court of India on the Glivec case, though does not serve the business interests of pharma MNCs, definitely signals the triumph of justice over ruthless patient exploitations. It also vindicates that this particular rule of law, as enacted by the Indian Parliament, is indeed for the best interest of the patients of India at large.

This verdict could well be construed as a huge lesson to learn and implement by other like minded countries, across the world.

Having a glimpse at the pharmaceutical innovations, which are often laced by crafty hypes created by expensive PR Agencies of the pharma lobby groups, the global thought leaders do tend to believe, rather strongly, that Section 3(d) of the Patents Act of India would encourage more ‘First-in-class’ innovations, in the long run, benefiting all.

Such a provision, if implemented by many countries, could also help saving significant wasteful expenditures towards ‘Me-too’ type pharma R&D, favorably impacting billions of lives, across the world.

That said, the question keeps haunting – ‘Sans Hype, Quo Vadis Pharma Innovation?

By: Tapan J. Ray 

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.