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Regulatory Data Protection (RDP) and its need in India: The Myth versus Reality

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THE MYTH:

An attempt to delay the launch of Indian generics:

Some in India feel that Regulatory Data Protection (RDP), is a deliberate attempt by the innovator companies to delay the launch of the generic equivalent of patented products in India, as long as they possibly can.

Thus they feel that why should one re-invent the wheel? Why should the generic pharmaceutical companies be not allowed to continue with the current requirement by the Drug Controller General of India (DCGI) to establish only the ‘bio-equivalence of an innovator drug to get the marketing approval of the generic equivalent in India?

RDP will effect export in non-regulated markets:
They further argue that India currently exports its pharmaceutical products to around 50 non-regulated markets of the world. Thus the enforcement of RDP would jeopardize Indian Pharmaceutical exports in those countries affecting the economy of the country.

RDP is a non-binding clause in TRIPS:

Regarding Article 39(3) of TRIPS, which indicates protection of regulatory data against “disclosure” and “unfair-commercial use”, this group opines that this is a non-binding Article of TRIPS, neither does it specify any timeline to protect such data. Moreover, they feel, that only the “undisclosed data” may be protected and the data already “disclosed” ‘need not to be protected’.

RDP is an attempt towards “evergreening” the patent:

The proponents of this interpretation believe that RDP is just an attempt to “evergreen” a patent, extending the patent life of a New Chemical Entity (NCE) or (NME) beyond 20 years.

THE REALITY:

Just Like Patents, Regulatory Data need to be protected to encourage innovation in India:

This group feels that generation of exhaustive regulatory data entails very significant investment in terms of money, energy and time. These are very high risk investments as approximately one in 5000 molecules researched will eventually see the light of the day in the market place. It is worth noting that clinical development of an NCE/NME costs around 70%, while the cost of discovery of the same NCE/NME is around 30% of the total costs. It is estimated that the entire process of drug development from discovery to market takes an average of 10 years and costs on an average U.S.$ 1.7 Billion in the developed markets of the world.

Since such voluminous regulatory data are not only costly and time consuming but also proprietary in nature, these need to be protected by the regulators. Regulatory Data Protection (RDP), therefore, has been widely recognized as an integral part of the Intellectual Property Rights (IPR).

The agreement on Trade Related aspects of Intellectual Property Rights (TRIPs) also recognizes the “protection of undisclosed information” as being an Intellectual Property, which needs to be protected.

Article 39.3 of TRIPs Agreement clearly articulates the following:

“Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”

Intellectual Property Rights (IPRs) mentioned in Article 39.3 of TRIPS are commonly referred to as “Data Exclusivity” in the U.S. and “Data Protection” or “Regulatory Data Protection” in the European Union (EU). These are all the very same.

RDP is an independent IPR; and should not be confused with other IPRs, such as patents:

Bringing an NCE/NME to the market involves two critical steps:

1. Discovery of NCE/NME:

The drug discovery right of the originator is protected in the form of a patent.

2. Drug development:

The innovator will require generating intensive, time consuming and expensive pre-clinical and
clinical data to meet the regulatory needs for bringing the new drug to the market. Such data
needs to be protected by the drug regulators.

It is understood that both the above steps are absolutely necessary to meet the unmet needs of the patients. The civil society gets the benefits of the new drugs only after these two steps are successfully completed.

The rationale for Regulatory Data Protection (RDP):

Irrespective of what has been indicated in Article 39.3 of TRIPS, RDP is clearly justifiable on the following grounds:

Generation of Data by the originator consists of “considerable efforts”. Submission of clinical data is a statutory regulatory requirement. Were it not for the obligation to provide these data to the Government, such data would have remained completely under control of the originator. It is, therefore, a reasonable obligation on the part of the Government as a ‘gate keeper’ to respect confidentiality of the data in terms of non-reliance and non-disclosure. Any failure by the Government to provide required protection to the data could lead to “unfair commercial use”.

Since such data are collected through various phases of clinical evaluation, involving considerable costs, time and energy, these are immensely valuable to the originator and need to be adequately protected by the drug regulators.

As these data are proprietary in nature, any access or permissibility for use of such data by the second applicant without concurrence of the originator is unfair on grounds of propriety and business ethics.

Given the imbalance between the costs to the originator of getting marketing approval for its product and the costs of the ‘copy cat’ coming to the market, the research based industry will not have adequate incentive without RDP to continue to get engaged in important R&D activities. In that scenario, newer and better drugs, particularly for untreated and under-treated medical conditions will not be available to the patients.

Without RDP, the originator of the innovative drugs would be placed at an unfair, commercial disadvantage when compared to their generic competitors, who do not incur similar costs of meeting the mandatory requirements of drug regulatory authorities for marketing approval of the drug.

The distinctiveness of the two incentives, namely, Patent Protection and Data Protection is recognized in countries which are leading in research and development in pharmaceuticals.

RDP will not affect exports of Indian pharmaceutical products to the non-regulated markets:

This is because RDP deals with marketing of products patented in India within the territory of India. RDP will in no way affect the ability of any generic manufacturer either to produce the bulk drug active or to formulate its dosage forms for exports in the non-regulated markets, as long as the product is not sold within the territory of India for which both the patent and RDP will be valid.

Disadvantages of not having RDP in India:

According to the U.S. National Institute of Health (NIH), lack of RDP in India is the primary reason why India ranks only 9th (compared to China which ranks 2nd), in funding given by NIH outside U.S.A.

An Expert Committee under the Chairmanship of Dr. R.A. Mashelkar, an eminent scientist, also highlighted significance of Regulatory Data Protection, as below:

“In order to ensure enabling environment, the regulatory division dealing with the applications concerning new drugs and clinical trials would be required to develop suitable mechanisms to ensure confidentiality of the submissions.”

RDP – The International Scenario:

A review of National Laws relating to the protection of Registration Data in the major WTO Member-States reveals that most of the countries have recognized and appreciated the role of RDP.

Although there is no uniform standard that is followed by the countries while enacting and implementing the laws related to RDP, there is however a common principle that is followed. The laws generally specify the conditions under which Regulatory Data Protection can be sought and the period for which the “originator” can enjoy the exclusivity after the marketing approval is granted in the country. The period of RDP is typically between 5 – 10 years.

As per an article titled “Complying with Article 39.3 of TRIPs… A Myth or Evolving Reality” by Dr. Prabuddha Ganguli, around sixty nations around the world including China follow RDP in their respective countries.

RDP and the generics:

Regarding the arguments that RDP provisions will act as a barrier to the development of generics, resulting in the erosion of generics market. This argument is based on invalid assumptions. The following facts will prove the irrelevance of these arguments propounded by the domestic generic lobby:

1. Data Protection refers only to new products registered/patented in India. It will not affect the generic drugs already in the market.

2. U.S.A. is an outstanding example which shows that research based industry and generic industry can co-exist, giving dual benefits of innovative medicines and cheaper copies of off-patent medicines to the general public.

3. More the patented medicines, more will be generic drugs after expiry of their patents.

4. In the U.S.A. which has a long standing Data Protection (Exclusivity) regime, the market penetration of generics is amongst the highest in the world and stands at nearly half of all the prescriptions.

5. After introduction of Hatch Waxman Act in 1984, which provided for a 5 year period of Data Protection, there has been a spurt of development of new drugs as also entry of off-patent generics into the US market.

RDP is not ‘evergreening’ :

In most of the cases, the period of patent protection and RDP will run concurrently. The ground reality will be that innovator companies will launch their products in India within as short a time gap as possible from the launch of those products anywhere in the world. The period between introduction of new drugs elsewhere and their introduction in India has been continuously shrinking. The range of such period between 1965 and 1988 was 4 years to 13 years. The period during 1990 to 1999 ranges between 0.25 year and less than 2 years.

During the debate on Data Protection it is asserted in some quarters that RDP and patents offer “double protection”. They do not, by any means. Fundamentally, the two forms of Intellectual Property are like different elements of a house which needs both a strong foundation and a roof to protect its inhabitants. RDP cannot extend the length of a patent which is a totally separate legal instrument. While patent protects the invention underlying the product, RDP protects invaluable clinical dossier submitted to the drugs regulatory authority, from unfair commercial use and disclosure. The duration of RDP, as stated above, is typically half or less of the product patent life.

Conclusions:

In my view RDP will benefit the pharmaceutical innovation eco system India, as it has done to many other countries. Hence India should implement RDP without further delay. It will be reasonable to have a provision of at least 5 years of RDP from the date of marketing approval in India, on the same lines as China.

RDP should be provided by making an appropriate amendment in Schedule Y of the Drugs & Cosmetics Act to bring India into conformity with its international legal obligations and with the practices of other members of the WTO from both the developed and developing nations of the world.

These provisions, in my view, will go a long way in sending a very positive signal to the international community as well as to our own research based pharmaceutical companies to accelerate investment in this vital sector making India emerge as a global powerhouse in pharmaceuticals, sooner than later.

By Tapan 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.

Open Source Drug Discovery (OSDD) initiative for the tropical diseases by CSIR and cancer by GlaxoSmithKline deserves a big applaud and support from all concerned.

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As the name suggest the ‘Open Source Drug Discovery (OSDD)’ is an open source code model of discovering a New Chemical Entity (NCE) or a New Molecular Entity (NME). In this model all data generated related to the discovery research will be available in the open for collaborative research inputs. The licensing arrangement of OSDD where both invention and copyrights will be involved, are quite different from any ‘Open Source’ license for a software development.

In OSDD, the key component is the supportive pathway of its information network, which is driven by three key parameters of open development, open access and open source.

The Objectives of OSDD:

The key objective of OSDD is to encourage drug discovery initiatives, especially for the neglected diseases of the world to make these drugs affordable to the marginalized people, especially of the developing world.

International initiative:

In June 2008, GlaxoSmithKline (GSK) announced in Philadelphia, “It was donating an important slice of its research on cancer cells to the cancer research community to boost the collaborative battle against this disease.”

With this announcement genomic profiling data for over 300 sets of cancer cell lines was released by GSK to the National Cancer Institute’s bioinformatics grid. It has been reported that around 1000 researchers actively contribute to this grid from across the industry, research institutes, academia and NGOs.

Many believe that the OSDD initiative will gain momentum to encourage many more academic institutions, researchers and even smaller companies to add speed to the drug discovery process and at the same time make the NCEs/NMEs coming through such process much less expensive and affordable to a large section of the society.

On an average it takes about 8 to 10 years to bring an NCE/NME to market with a cost of around U.S$ 1.7 billion.

OSDD in India:

In India, Dr. Samir Brahmachari, the Director General of the Council of Scientific and Industrial Research (CSIR) is the champion of the OSDD movement. CSIR believes that for a developing country like India, OSDD will help the common man to meet his unmet medical needs in the areas of neglected tropical diseases.

OSDD in India is a global platform to address the neglected tropical diseases like, tuberculosis, malaria, leishmaniasis by the best research brains of the world, together.

To fund the OSDD initiative of the CSIR the Government of India has allocated around U.S $40 million and an equivalent amount of funding would be raised from international agencies and philanthropists.

It has been reported that current priority of CSIR in its OSDD program is the tuberculosis disease area.

Why tuberculosis?

The published reports indicate, in every 1.5 minutes one person in India dies of tuberculosis and about 33 percent of the global population is infected primarily with Mycobacterium tuberculosis. The world is still quite far from having an effective vaccine or drug, which can offer long term protection against this dreaded disease.

Partnerships of Industry with belief in Open Source systems and models with CSIR in its OSDD project for tuberculosis, could help finding out a suitable answer to this long standing problem, sooner than later.

Success of OSDD initiative of CSIR:

Late November 2009, I received a communication from the CSIR informing that their OSDD project, since its launch in September 2009, has crossed 2000 registered users. The pace of increase in the number of registered users indeed reflects the confidence this initiative has generated among the interested researchers, the world over.

OSDD community of CSIR has several credits to be proud of including open peer review, open funding review, large number of real time data on open lab notebook.

CSIR has also indicated that the next big leap planned by them is to completely re-annotate the MTb genome for which OSDD has launched ‘Connect to Decode’ 2010 (http://crdd.osdd.net). They initially expected about 150 participants to join, but within a week, they got about 450 participants. That is really the strength of collaboration on OSDD!

Congratulations CSIR and its leader Dr. Samir Brahmachari.

By Tapan 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.

India urgently needs a total overhaul and reform of its public healthcare system with a holistic approach – NRHM and RSBY are laudable initiatives.

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Over a period of time India had made significant improvement in various critical health indicators despite frugal public health spending by the government, which is just around 1 percent of GDP of the country. Such a low government spend towards public health takes India to the bottom 20 percent of countries of the world, in this respect.Overall progress of the country’s public healthcare system is, consequently, commensurate to the nation’s spending towards this vital sector. Only 35 percent of country’s population has now access to affordable modern medicines. Even many ASEAN countries are far ahead of India in their achievements towards public healthcare services. Such a grim scenario prompts us to understand the infrastructural and financial dimensions of the public healthcare system of the country to enable us to suggest appropriate reform measures for this sector to the policy makers.Very recently, the Prime Minister of the country Dr. Manmohan Singh indicated the intent of his government to raise the government spending towards public health to around 3 percent of the GDP. Health being a state subject in India, both the State and Central Governments will need to take their best foot forward towards this direction.

Fund Allocation towards public healthcare:

In the Eleventh Five Year Plan, the fund allocated by the government towards public healthcare shows a significant increase. The launch of ‘National Rural Health Mission (NRHM)’, which emphasizes community based monitoring along with decentralized planning and implementation augers well for the nation and vindicate, at least, the resolve of the government towards this direction.

Impediments to make NRHM a great success:

There are some serious infrastructural requirements to scale-up NRHM and make it successful. These are as follows:

1. More number of specialists, doctors, nurses and paramedics

2. More medical colleges and nursing schools

3. Less developed states should be financially and technologically helped to create public healthcare infrastructure

4. The student teacher ratio to be enhanced in specialties and super specialties from the current level of 1:1 to 2:1

5. Capacity building at the Medical colleges of the State Governments needs to be considered without further delay

6. The number of post-graduate medical seats needs to be increased, all over the country.

It is envisaged that all these critical steps, if taken with missionary zeal, will help increasing the number of post-graduate specialists from the existing level of 13000 to 18000, in the next five years.

Healthcare delivery:

Even if all these are achieved public healthcare delivery will still remain a key issue to achieve the country’s objective to provide affordable healthcare to all. The poor and marginalized people of our society must be covered adequately by the public healthcare system to the best extent possible.

Improving access:

To improve access to public healthcare services for the common man, India very badly needs structural reform of its public healthcare system, with a clear focus on preventive healthcare. This will in turn help the country reduce the burden of disease.

Healthcare financing:

In 2001 The Journal of Health Management in a study using National Health Accounts (NHA) as a tool of analysis reported:

“76 per cent of health sector revenues come from private sources, of which almost 50 per cent go to private providers and 21 per cent are spent on drugs. Further, 7 per cent of household out-of-pocket expenditure is used as non-drug expenditure for using government facilities for out-patient and in-patient treatment. This has important policy implications for the government.”

Along with increasing healthcare needs across all sections of the society, especially in the low income and the backward states, a very high percentage of out-of-pocket household expenditure towards healthcare, low public budgetary allocations and sluggish health outcomes, are calling for a robust healthcare financing model for the country.

Why is healthcare financing so important in a developing country like, India?

The largest number of poor population of the world resides in India. It has been reported that around three-fourth of over one billion population of the country earns less than two dollars a day. Coupled with poor hygienic condition this section of population is more prone to various illnesses, especially tropical diseases. India is one of those very few emerging economic super powers where around 90 percent of its population is not covered by any form of health care financing.

Under such circumstances, it has been widely reported that the poor very often will need to borrow money at a very high rate of interest or sell whatever small assets they own, further eroding their capability to come above the poverty line, in the longer term.

Thus to provide adequate health insurance cover to the marginalized section of the society including a large number of the rural population, the country is in a dire need to develop a workable and tailor-made healthcare financing model instead of pushing hard the existing ones. This tailor-made model should also include the domiciliary treatment, besides costs of hospitalization.

New healthcare reform process in India should include the healthcare system in its entirety with a holistic approach, starting from access to healthcare to its management and delivery, strengthened by a robust micro-healthcare financing system.

Rashtriya Swasthya Bima Yojna (RSBY): A good initiative by the government:

To partly address the above issue, on October 1, 2007 the Government of India announced a health insurance scheme for the Below Poverty Line (BPL) families in the unorganized sector called Rashtriya Swasthaya Bima Yojna (RSBY).

In RSBY, BPL families are entitled to more than 700 in-patient medical procedures with a cost of up to 30,000 rupees per annum for a nominal registration fee of 30 rupees. Pre-existing medical conditions are covered and there is no age limit. Coverage extends to the head of household, spouse and up to three dependents.

RSBY appears to benefit those people who need it the most. However, how effective will be the implementation of this scheme, still remains a key question. If implemented exactly the way the scheme was conceived, it has the potential to address the healthcare financing issue of around 28 percent of the population currently living below poverty line.

The initial response of RSBY has been reported to be good, with more than 46 lakh BPL families in eighteen States and Union Territories having been issued biometric smart cards, so far.

Conclusion:

To provide affordable healthcare services to all, India urgently needs a total overhaul and reform of its public healthcare system with a holistic approach. The steps so far taken by the government with the launch of NRHM and RSBY are laudable, but are these enough?

By Tapan 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.

Innovation, IPR and Altruism in Public Health

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The ongoing debate on innovation, Intellectual Property Rights (IPR) and public health is gaining momentum.Even in India, the experts and various stakeholders of the pharmaceutical industry got involved in an interactive discussion with the Director General of the World Intellectual Property Organization (WIPO), Dr. Francis Gurry on November 12, 2009 at New Delhi, on this subject among many other issues.During the discussion it appeared that there is a need to communicate more on how innovation and IPR help rather than hinder public health. At the same time there is an urgent need to consider by all the stakeholders of the pharmaceutical industry how the diseases of the developing countries may be addressed, the best possible way. Some initiatives have already been taken in this respect with the pioneering ‘patent pool’ initiative of GlaxoSmithKline (GSK) and ‘Open Source Drug Discovery (OSDD)’ by the Council of Scientific and Industrial Research (CSIR) of the Government of India.Innovation, IPR, Access to medicines and the neglected people of India:

In India, the key issue is lack of access to modern medicines by over 650 million people of its population. Have we, by now, been able to effectively address the issue of access to existing affordable generic medicines to these people, which are mainly due to lack of adequate healthcare infrastructure, healthcare delivery system and healthcare financing models? Thus IPR does not seem to be a key reason for such poor access to medicines in India; at least for now. Neither, is the reason due to inadequate availability of affordable essential medicines for the neglected tropical diseases. The reason, as is widely believed, is inadequate focus on the neglected people to address their public health issues.

How can medicines be made more affordable without addressing the basic issue of general poverty?

It is a known fact that the price of medicines is one of the key determinants to improve access to medicines. However, the moot question is how does one make a medicine more affordable without addressing the basic issue of general poverty of people? Without appropriately addressing the issue of poverty in India, affordability of medicines will always remain as a vexing problem and a public health issue.

The positive effect of the debate on innovation, IPR and public health:

One positive effect of this global debate is that many global pharmaceutical companies like Novartis, GSK, and Astra Zeneca etc. have initiated their R&D activities for the neglected tropical diseases of the world.

Many charitable organizations like Bill and Melinda Gates Foundation, Clinton Foundation etc. are allocating huge amount of funds for this purpose. The Government of India is also gradually increasing its resource allocation to address the issue of public health, which is still less than adequate though.

These developments are definitely bringing in a change, slow and gradual – a change for the better. However, all these are still grossly inadequate and insufficient to effectively address the public health issues of India for the suffering majority.

Still much is needed to be done:

Still much is needed to be done for the developing countries like, India in the space of public health, though since last decades significant progress has been made in this area through various initiatives as mentioned above. Additional efforts are warranted for the sustainability of these initiatives, which have not yet gained the status of robust and sustainable work models. However, the government in power should shoulder the key responsibility to garner all resources, develop and implement the new healthcare financing models through appropriate healthcare reform measures, to achieve its long cherished goal of providing affordable public healthcare to all.

Conclusion:

Innovation, as is widely acknowledged, is the wheel of progress of any nation. This wheel should move on, on and on with the fuel of IPR, which is an economic necessity of the innovator to make the innovation sustainable.

Altruism, especially in the area of public health, may be desirable by many. Unfortunately, that is not how the economic model of innovation and IPR works globally. Accepting this global reality, the civil society should deliberate on how innovation and IPR can best be used, in a sustainable manner, for public health, more so, for the marginalized population of a country.

By Tapan 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.

IPR, Climate Change and addressing the issue of transfer of Carbon abatement technology in the developing world.

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To address all pervasive global challenge of climate change, access to efficient and cost effective carbon abatement technology to reduce the greenhouse effect has become a very important issue, especially for an emerging economy like, India. This issue perhaps will gain even more importance after the forthcoming Copenhagen Summit on climate change.
Various schools of thoughts:
Many experts argue that patents on various efficient carbon abatement technology developed by the western countries are making it increasingly difficult for the emerging economies of the world to address this issue, in a cost effective manner.

Another group of experts argue with equal zest that all patented technologies do not cost very high for efficient carbon abatement. Out of various types of such patented technologies, which are available globally to reduce the greenhouse effect, some may cost high, but many of them are also available at quite a low cost.

The third group says that many other efficient technologies are available to reduce carbon emission, which are not covered by any Intellectual Property Right (IPR), at all. Developing or emerging economies should consider these technologies to address this global issue, effectively.

An encouraging trend:

An encouraging trend is now emerging where the developing countries are also applying for patent on such technology with an increasing number. A recent report by the COPENHAGEN ECONOMICS highlights that during last four years, while the number of global patent on the carbon abatement technology increased by 120 per cent over the corresponding period of previous four years, the number of such patents from the developing or emerging economies increased by around 550 per cent. This is indeed a very interesting trend.

Difference in the number of patented technologies within the developing countries:

The same report also indicates that there is a striking difference in the number of patent protected carbon abatement technologies even within the developing and emerging economies. As per this report, around 99 percent of all patent protected technologies are from a small group of emerging economies, whereas just a meagre 0.6 percent of these patented technologies are from a large number of lower-income developing economies. This anomaly is believed to be mainly due to commercial reasons, as the owners of these patents are from the developed economies of the world.

A comparison between India and China:

The report highlights that 40 percent of the carbon abatement technology patents in China are locally owned against around just 14 percent in India.

Conclusion:

Be that as it may, such studies perhaps will go in favour of the argument that patent protected carbon abatement technologies should not be considered as a barrier to technology transfer for reducing carbon emission by the low-income developing countries of the world. Also the IPR by itself perhaps will not be an impediment in the transfer of carbon abatement technology from the developed economies.

Many believe that rather than technological reasons, economic reasons are coming in the way in reducing carbon emission in the low income developing countries. The factors like, lack of adequate expertise to develop carbon abatement technologies locally, small market size to warrant a local manufacturing facility, low purchasing power etc. all put together play a significant role in appropriately addressing the greenhouse effect by these countries.

The local government of the respective developing countries should take all these factors into consideration and come out with appropriate and robust policy measures, which also should include lucrative fiscal incentives for using cheaper and efficient carbon abatement technology, to contain the greenhouse effect, efficiently and effectively.

By Tapan 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.

To prevent ‘counterfeit medicines’ from reaching the patients is the nation’s public health responsibility: Are we still in a denial mode to even accept the existence of this public health menace?

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In November 7, 2009, Financial Express reported with a headline,”Generic drug companies see a bitter pill in counterfeit“, because some believe that it has an in-built intellectual property right connotation.
The dictionary definition:

The word ‘counterfeit’ may be defined as follows:

1. To make a copy of, usually with the intent to defraud

2. To carry on a deception; dissemble

4. To make fraudulent copies of something valuable

5. A fraudulent imitation.

What does Indian Drugs and Cosmetics Act say?

May be for this reason the Drugs and cosmetics Act of India has specified that manufacturing or selling of the following types of drugs are punishable offence:

Section 17: Misbranded drugs

Section 17-A: Adulterated drugs

Section 17-B: Spurious drugs

No one has asked, so far, that as misbranding could involve trademark and design, why should it fall under Drugs and Cosmetics Act?

This was done in the past by the law makers because they believed that any attempt to deliberately and fraudulently pass off any drug as something, which it really is not, could create a serious public health issue, leading to even death.

Be that as it may, the pharmaceutical industry all over the world sincerely believes that counterfeit drugs involve heinous crime against humanity.

Definition of counterfeit drugs should cover the all types of medicines, which are not genuine:

Definition of counterfeit drugs should, therefore, cover the entire gamut of medicines, which are not genuine. Such medicines could be a fraudulent version of patented, generic or even traditional medicines and have nothing to do with patents or patent infringements.

At the same time it sounds very reasonable that a medicine that is authorized for marketing by the regulatory authority of one country but not by another country, should not be regarded as counterfeit on this particular ground in the other country, if it is not made available fraudulently.

The recent survey on ‘spurious’ and ‘sub-standard’ drugs by the Government of India:

To assess the magnitude of the menace of counterfeit drugs, Financial Express dated November 12, 2009 reported that much hyped “world’s largest study on counterfeit drugs” conducted by the Ministry of Health of the Government of India with the help of the Drug Controller General of India’s office, has come to the following two key conclusions:

1. Only 0.0046% of the drugs in the market were spurious

2. Quantum of sub-standard drugs in India is just 0.001%

From this report, it appears that India, at this stage, has nothing to worry about this public health hazard!!!
It is indeed quite baffling to understand, why did the government keep ‘misbranded drugs’, as specified in the Drugs and Cosmetics Act of India, outside the purview of this study.

Be that as it may, it appears that this survey has raised more questions than what it had attempted to answer. Such questions are expected to be raised not only by the pharmaceutical industry of India, its stakeholders and the civil society at large, but by the global experts, as well.

The problem of counterfeit is more prevalent in countries where regulatory enforcement is weak:

The menace of counterfeit medicines is not restricted to the developing countries like, India. It is seen in the developed countries, as well, but at a much smaller scale. Thus it is generally believed that the issue of counterfeit drugs is more common in those countries, where the regulatory enforcement mechanism is weak.

A study done by IMPACT in 2006 indicates that in countries like, the USA, EU, Japan, Australia, Canada and New Zealand, the problem is less than 1%. On the other hand, in the developing nations like parts of Asia, Latin America and Africa more than 30% of the medicines are counterfeits.

The role of ‘The World health Organization (WHO):

To effectively root out this global menace, the leadership role of the WHO is extremely important. Across the world, patients’ need protection from the growing menace of counterfeit medicines. As a premier organization to address the needs of the global public health issues and especially for the developing world, the WHO needs to play a key and much more proactive role in this matter.

Conclusion:

All stakeholders of the pharmaceutical industry must be made aware more effectively, without further delay, of the health threats posed by counterfeit medicines. Authorities and organizations like the Drug Controller General of India (DCGI) and its regulatory and enforcement agencies, healthcare professionals, patients, all pharmaceutical manufacturers, drug distributors, wholesalers and retailers should collaborate to play a very active and meaningful role in curbing the counterfeit drugs from reaching the innocent patients.

By Tapan 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

For greater transparency in the relationship between physicians and the pharmaceutical companies, does India need an Act like, proposed ‘The Physician Payment Sunshine Act’ of the USA?

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As we discussed earlier, to make the pharmaceutical companies disclose and report various types of payments made to the physicians, two Senators of the United States of America, Chuck Grassley and Herb Kohl introduced a bill called ‘The Physician Payment Sunshine Act’ in January, 2009.If this bill is passed in 2010, the government will make available to the public by 2011 all types of payments made to the physicians by the pharmaceutical companies over a cumulative value of US $ 100.Items of disclosure:

Among various other heads, the following items related to the “payment made to the physicians’’ will require to be reported:

• Consulting Fees

• Compensation for services other than consulting

• Honoraria

• Gifts

• Entertainment

• Food

• Travel

• Education

• Research

• Charitable Contributions

• Royalties or licenses

• Current or prospective ownership or investment interests

• Compensation for serving as a faculty member or as a speaker for a continuing medical education program

• Grant

• Reporting will be required for compensation towards serving as faculty, or as a speaker for a CME program, and grants.

• Any other nature of the payment or other transfer of value as defined by the government

Research payments:

Pharmaceutical companies will also require reporting aggregate amounts of research payments in a specified manner.

Items exempt from disclosure:

There will be items, as mentioned below, which will be exempted from such reporting:

• Product samples

• Payments in the aggregate of less than $100

• The loan of a device for less than 90 days

• Patient education materials

• Warranty replacements (devices)

• Items for use as a patient

• Discounts and rebates

• In-kind items used in charity care

• Dividends from a publicly-traded company

Penalties for default from disclosure:

Proposed penalties have been categorized as follows:

• For unintentional failure to report: fines from US $1,000 – US $10,000 for each payment not reported with a cap of US $150,000/year

• For intentional failure to report: fines from US $10,000 – US $100,000 for each payment not reported with a cap of US $1 million/year.

World Medical Association (WMA) Statement Concerning the Relationship Between Physicians and Commercial Enterprises:

Meanwhile, WMA is also trying to address this vexing issue and coming closer to some sort of voluntary disclosure at their end, as well.

Such type of statement was first adopted by the WMA in its General Assembly at Tokyo, Japan in October 2004. Recently in its General Assembly held at New Delhi in October 2009, the statement was further amended coming closer to the disclosure of payments.
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The preamble of the amended statement articulates the following:

“In the treatment of their patients, physicians use drugs, instruments, diagnostic tools, equipment and materials developed and produced by commercial enterprises. Industry possesses resources to finance expensive research and development programmes, for which the knowledge and experience of physicians are essential. Moreover, industry support enables the furtherance of medical research, scientific conferences and continuing medical education that can be of benefit to patients and the entire health care system. The combination of financial resources and product knowledge contributed by industry and the medical knowledge possessed by physicians enables the development of new diagnostic procedures, drugs, therapies, and treatments and can lead to great advances in medicine.

However, conflicts of interest between commercial enterprises and physicians occur that can affect the care of patients and the reputation of the medical profession. The duty of the physician is to objectively evaluate what is best for the patient, while commercial enterprises are expected to bring profit to owners by selling their own products and competing for customers. Commercial considerations can affect the physician’s objectivity, especially if the physician is in any way dependent on the enterprise.

Rather than forbidding any relationships between physicians and industry, it is preferable to establish guidelines for such relationships. These guidelines must incorporate the key principles of disclosure, avoidance of obvious conflicts of interest and the physician’s clinical autonomy to act in the best interests of patients.
These guidelines should serve as the basis for the review of existing guidelines and the development of any future guidelines.”

This new statement of the WMA, having a remarkable similarity with the ‘Codes of marketing Practices’ of the pharmaceutical industry associations in India, like Organization of pharmaceutical Producers of India (OPPI) and Indian Drug Manufacturers’ Association (IDMA) is indeed a welcome step in the right direction.

Conclusion:

Along with the self regulation initiatives by both the industry and WMA, this bill, if passed, will surely and significantly improve the transparency related to the transaction between the pharmaceutical companies and the physicians to the public at large in the US to start with. However, bringing research within the ambit of this bill could possibly be a contentious issue.

Be that as it may, in India a large section of the civil society still feels that it is now high time for the Government of India to decide whether the nation needs an Act like the proposed ‘Physician Payment Sunshine Act’ of the US to bring in greater transparency in the process of various financial transactions between the pharmaceutical industry in India and the physicians, along with the continuing initiatives of self-regulations by both the industry and the physicians.

By Tapan 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.

Will mandatory disclosure of ‘payments to physicians’ by the pharmaceutical companies be an overall part of “Healthcare reform process” in the US and what about India?

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The brief Scenario in India:
In India over 20, 000 pharmaceutical companies of varying size and scale of operations are currently operating. It is alleged that lack of regulatory scrutiny is prompting many of these companies to adapt to ‘free-for-all’ types of aggressive sales promotion and cut-throat marketing warfare involving significant ‘wasteful’ expenditures. Such practices involve almost all types of their customer groups, excepting perhaps the ultimate consumer, the patients.

Unfortunately in India there is no single regulatory agency, which is accountable to take care of the healthcare needs of the patients and their well being.

The pharmaceutical industry of India, in general, has expressed the need to self-regulate itself effectively, in the absence of any regulatory compulsion. However, many activists groups and NGOs feel that the bottom-line in this scenario is the demonstrable transparency by the pharmaceutical companies in their dealings with various customer groups, especially the physicians.

The brief scenario in the US:

Like in India, a public debate has started since quite some time in the US, as well, on allegedly huge sum of money being paid by the pharmaceutical companies to the physicians on various items including free drug samples, professional advice, speaking in seminars, reimbursement of their traveling and entertainment expenses etc. All these, many believe, are done to adversely influence their rational prescription decisions for the patients.

As the financial relationship between the pharmaceutical companies and the physicians are getting increasingly dragged into a raging public debate, it appears that there is a good possibility of making disclosure of all such payments made to the physicians by the pharmaceutical companies mandatory by the Obama administration, as a part of the new US healthcare reform process.

As I said in my earlier article, Eli Lilly, the first pharmaceutical company to announce such disclosure voluntarily around September 2008 has already uploaded its physician payment details on its website.

US pharma major Merck has also followed suit and so are Pfizer and GSK. However, the effective date of their first disclosure details is not yet known.

In the meantime, Cleveland Clinic and the medical school of the University of Pennsylvania, US are in the process of disclosing details of payments made by the Pharmaceutical companies to their research personnel and the physicians. Similarly in the U.K the Royal College of Physicians has been recently reported to have called for a ban on gifts to the physicians and support to medical training, by the pharmaceutical companies.

Conclusion:

Currently in the US, both in Senate and the House of Congress two draft bills on ‘The Physician Payment Sunshine Act’ are pending. It appears quite likely that Obama Administration, with the help of this new law, will make the disclosure of payments to physicians by the pharmaceutical companies mandatory, along with its much discussed new healthcare reform process.

If President Obama’s administration takes such regulatory steps will Dr. Manmohan Singh government prefer to stay much behind?

I shall try to explore that emerging scenario in my next blog post.

By Tapan 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.