Tag Archives: pharmaceutical

Emerging markets and a robust oncology portfolio expected to be the future growth engine of the global pharmaceutical industry… but not without associated pricing pressures.

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When the growth rate of the developed markets of the global pharmaceutical industry started slowing down along with the declining R&D productivity, the emerging markets were identified as the new ‘El-Dorado’ by the global players. At the same time, new launch of anti-cancer drugs, more in number, started giving additional thrust to the growth engine of the industry, at least in the developed markets and for the ‘creamy layers’ of the emerging markets of the world. As cancer is being considered as one of the terminal illnesses, the cancer patients from all over the world, would like to have their anti-cancer medications, at any cost, even if it means just marginal prolongation of life with a huge debt burden.According to a recent study done by the Cancer Research, UK, despite significant decline in the overall global pharmaceutical R&D productivity over a period of time, in a relative yardstick, newer anti-cancer drugs have started coming up to the global market with a much greater frequency than ever before. ‘Pharmacy Europe’reports that 18 percent, against a previous estimate of 5 percent of 974 anti-cancer drugs will see the light of the day in the global market place, passing through stringent regulatory requirements. This is happening mainly because of sharper understanding of the basic biology of the disease by the research scientists.Another study reports that between 1995 and 2007 such knowledge has helped the scientists to molecularly target ‘kinase inhibitors’, which are much less toxic and offers much better side effect profile. Well known anti-cancer drug Herceptin of Roche is one of the many outcomes of molecularly targeted research.

Price of Anti-cancer drugs:

Although in the battle against the much dreaded disease cancer, the newer drugs which are now coming to the market, are quite expensive. Even in the developed markets the healthcare providers are feeling the heat of the cost pressure of such medications, which would in turn impact the treatment decisions. Probably because of this reason, to help the oncologists to appropriately discuss the treatment cost of anti-cancer drugs with the patients, the American Society of Clinical Oncology recently has formed a task force for the same.

The issue is now being fiercely debated even in the developed markets of the world:

In the developed markets of the world, for expensive cancer medications, the patients are required to bear the high cost of co-payment, which may run equivalent to thousands of U.S dollars. Many patients are finding it difficult to arrange for such high co-payments.

Thus, it has been reported that even the National Institute of Health and Clinical Excellence (NICE), UK considers some anti-cancer drugs not cost-effective enough for inclusion in the NHS formulary, sparking another set of raging debate.

‘The New England Journal of Medicine’ in one of its recent articles with detail analysis, expressed its concern over sharp increase in the price of anti-cancer medications, specifically.

Is the global pharmaceutical industry in a ‘gold rush’ to get into the oncology business?

Recently ‘The New York Times’ reported some interesting details. One such was on the global sales of anti-cancer drugs. The paper reports that in 1998 only 12 anti-cancer drugs featured within the top 200 drugs, ranked in terms of global value turnover of each. In that year Taxol was the only anti-cancer drug to achieve the blockbuster status with a value turnover of U.S$ 1 billion.

However, in 2008, within top 200 top selling drugs, 23 were for cancer with three in the top ten, clocking a global turnover of over U.S$ 1 billion each. 20 out of 126 drugs recording a sales turnover over U.S$ billion each, were for cancer, impressive commercial growth story of which is far from over now.

How to address this issue?

Experts are now deliberating upon to explore the possibility of creating a ‘comparative effectiveness center’ for anti-cancer drugs. This center will be entrusted with the responsibility to find out the most cost effective and best suited anti-cancer drugs that will be suitable for a particular patient, eliminating the possibility of wasteful expenses, if any, with the new drugs, just because of their newness and some additional features, which may not be relevant to a particular patient. If several drugs are found to be working equally well on a patient, most cost effective medication will be recommended to the particular individual.

Some new anti-cancer medications are of ‘me-too’ type:

‘The Journal of National Cancer Institute’ reports that some high price anti-cancer drugs are almost of ‘me too’ type, which can at best prolong the life of a patient by a few months or even weeks. To give an example the journal indicated, ‘Erbitux for instance, prolongs survival in lung cancer patients by 1.2 months… at a cost of U.S$ 80, 000 for an 18 – week course of treatment.’

However, the manufacturer of the drug later told ‘The Wall Street Journal’ (WSJ), ‘U.S.$ 80,000 is like a sticker price, but the street price is closer to U.S$ 10,000 per month” i.e around U.S$ 45,000 for 18 week course of treatment.

Conclusion:

Even in the developed countries, the heated debate on expensive new drugs, especially, in the oncology segment is brewing up and may assume a significant proportion in not too distant future. India being one of the promising emerging markets for the global pharmaceutical industry, willy nilly will get caught in this debate, possibly with a force multiplier effect, 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.

The Indian and Global Pharmaceutical Industry – A brief perspective to meet the challenge of change

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A. INDIAN PHARMACEUTICAL INDUSTRY PERSPECTIVE:
January 1, 2005 ushered in a paradigm shift in the Indian Pharmaceutical Industry with the new product patent regime. Future of the industry, thereafter, will never be the same again as what we have been witnessing since 1970.

Gradually India, which was synonymous to cheaper copycat generic versions of products patented in most of the developed and emerging pharmaceutical markets of the world, is expected to transit through a relatively ‘lull period’ for a shorter duration, before it starts helping to establish India as a force to reckon with, in the pharmaceutical research and development (R&D) space of the world. We have seen some glimpses of the era to come by through initial basic research initiatives of companies like, Ranbaxy, Dr. Reddy’s Laboratories (DRL), Piramal Life Science and Glenmark. All such companies are gradually transforming their R&D focus from reverse-engineering to developing new chemical/molecular entity (NCE/NME) or novel drug delivery systems (NDDS).

Opportunities during the paradigm shift:

The low cost base, large English speaking technical talent pool and development of world class R&D facilities of the country will play the role of catalysts in this fast changing process and throw open many new vistas of opportunities for the industry to cash on.

At the same time, generic companies will play even more important global role than ever before. Many of them will no longer remain a local branded generic or generic player, they will open their wings to fly down to the important global destinations. Some others will collaborate with multi-national pharmaceutical companies (MNCs) in their contract research and manufacturing services (CRAMS) initiatives. For others, the domestic pharmaceutical market will still remain big and lucrative enough to grow their business.

However, those companies, which will not be able to effectively combat the ‘challenge of rapid changes’ will either perish or be gobbled-up by the big fishes in the consolidation process of the local and global pharmaceutical industry.

Some perspectives:

Though the domestic Indian pharmaceutical industry caters to around 70% of the requirements of pharmaceuticals of the nation, is highly fragmented. The industry manufactures 8% of the global production being the fourth largest producer of pharmaceuticals in terms of volume and employs over half a million people, mostly by around 300 large to medium sized companies in their local and global operations. Although around 6000 companies are engaged in manufacturing, many of them are third party manufacturers. Small manufacturers, who do not conform to ‘Schedule M’ requirements of the Drugs & Cosmetics Act will face or have already started facing trying times.

In terms of value, at present, India with around U.S 7.8 billion turnover, shares just around 2% of the global market with 14th in ranking. McKinsey forecasts that by 2015 India will record a turnover of U.S$ 20 billion and will improve its rank in the global pharma league table to 10th.

Key markets of the domestic Indian companies:

Although India still remains one of the major markets of the domestic Indian pharmaceutical companies, many of them have already established their business in the US, Europe, Latin America, Russian Federation, Africa, Middle East, South East Asia and even in Japan and Australia.

Contribution of India business of different Indian pharmaceutical companies to their global business varies based on their respective business strategies, from 63% of Zydus Cadila to around 16% of DRL, in 2007-08.

US market followed by Europe, is the main revenue earner for most of the large Indian companies. For example Ranbaxy generated around 27% and 20% of their global turnover from the US and Europe, respectively in 2008.

However, for some other companies like Wockhardt, Europe is a more important market than USA. Wockhardt generated around 54% of their global turnover from Europe, in 2007.

Global market entry strategy:

Different Indian companies adopted different market entry and expansion strategies in their globalization process. However, these have been mostly driven mergers and acquisitions.

Is the Indian pharmaceutical industry facing a dire need for an image makeover?

Despite significant contribution of the Indian pharmaceutical industry to provide relatively cheaper generic medicines to address a wide array of ailments of a vast majority of the population, the image of the industry to its stakeholders or even to public at large, is far from satisfactory.

There are some key perceptual reasons for the same. Some of these are as follows:

1. Pharmaceutical industry is making exorbitant profits at the cost of the basic healthcare needs of the common man.

This perception gets further strengthened when, for example, the National Pharmaceutical Pricing Authority (NPPA) demands crores of rupees from many pharmaceutical companies for overcharging to the patients and notices are served even attaching their properties to recover these dues.

2. The quality of all medicines is not reliable.

This gets vindicated when, for example, the government for its ‘Jan Aushadhi’ program refuses to buy from certain groups of licensed pharmaceutical manufacturers, predominantly on product quality parameters.

3. Some questions, do the pharmaceutical manufacturers in India manufacture medicines following the highest quality norms?

To answer to this question some people argue; if so, why will Indian manufacturers need stringent manufacturing quality certification of the drug regulators of the developed markets to export medicines in the those countries? Why the manufacturing quality certification given to these exporters by the Indian drug regulator is not accepted in those countries?

Moreover, when medicines are imported into India, we accept the quality norms of the drug regulators of the developed countries.

4. Some sections of the media highlight the alleged malpractices by the Indian pharmaceutical companies to promote their mediciness to the medical profession. Such alleged high expenditure towards product promotion is considered by many as avoidable wasteful expenses, the benefit of which can easily be passed on to the patients.

Indian pharmaceutical industry is yet to develop a uniform code of marketing practices, which will be applicable to all the pharmaceutical companies across the board and implement the same effectively, to address such allegations.

Multinational Companies – friends or foes?

To partly salvage the situation, at the same time, one notices open attempts are being made to project the multinational drug companies as demons, the exploiters with a suspicious agenda of thwarting the growth of the domestic companies. In such a scenario, it is indeed perplexing, when one sees the names of the Indian companies at the top of the NPPA lists who allegedly overcharged maximum amount of money to the common man.

What the industry should do jointly:

Under such sad circumstances, the entire industry should come together, take a hard look on itself first and extend its helping hands in public private partnership (PPP) initiatives for the benefit of the civil society.

Such PPP may not necessarily be charitable. It could focus on developing a robust healthcare financing model with industry expertise, for implementation with the government involvement for all strata of society. Or, for example, the industry should come out with a plan, which the US Pharmaceutical trade association – PhRMA has recently proposed to the Obama administration voluntarily on their ‘Medicare’ program, for the senior citizens of America.

For image makeover the name of the game is actual ‘demonstration’ of the good intent and NOT ‘pontification’ of what others should do, highlighting the identified loopholes in the government machineries.

B. GLOBAL PHARMACEUTICAL INDUSTRY PERSPECTIVE:

In the midst of the global financial meltdown, beginning 2009, no one is still able to fathom what impact, if at all, will it leave on to the global pharmaceutical industry.

In the most populous country of the world – China, in April 2009, the government unfolded the blueprints of new healthcare reform measures, covering the entire nation.

Similarly, in the oldest democracy and the richest country of the world – United States of America, President Barak Obama administration expressed their resolve to address important healthcare related issues, as an integral part of the economic reform of the country.

In other developed markets of the world like Europe and Japan intense cost containment pressure is in turn creating significant pricing pressure on pharmaceuticals, triggering the demand of greater use of cheaper generic formulations.

Financial meltdown though eroded the market capitalization of most of the companies; the growth of the global pharmaceutical industry remained unabated till 2008, albeit at a slower pace though. Many markets of the world witnessed a faster generic switch, fuelling higher volume growth of the generic segment of the industry.

Some perspectives:

In 2008 the global pharmaceutical market size was of U.S$ 780 billion, which is expected to grow to U.S$ 937 billion in 2012 registering a 5 year CAGR of around 5.5%. Sales worth U.S$ 253 billion came from just 100 blockbuster drugs, contributing around one third of the global pharmaceutical market.

USA with a retail revenue turnover of U.S$ 206 is the largest market of the world, though currently showing a sharp decline in its growth rate. The growth rate of the US is expected to drop further along with the patent expiry of other blockbuster drugs.

Just three countries of Europe, U.K, France and Germany contributed to 50% of pharmaceutical sales of entire Europe.

Doctors’ are no longer the sole decision maker to prescribe a medicinal product:

Just like in the US, one witnesses a change in the role of the medical professionals as a key decision maker to prescribe medicines for the patients in Europe, as well. More and more, payors like health insurance companies, NHS are assuming that role.

A shift from small molecule pharmaceuticals to large molecule biotech products:

As small molecule pharmaceuticals are coming under intense pricing pressure, the focus of new drug launches is shifting towards more expensive large molecule biotech drugs with much higher margins of profit increasing the treatment cost further.

The brighter side:

Growing middle class population with higher disposable income together with increase spending of the government towards healthcare, in most of these countries, are making the pharmaceutical industry grow at a much faster pace in the emerging markets like, Brazil, Venezuela, Russia, China, India, Turkey, Mexico and Korea. However, the revenue and profit earned by the global companies from the developed markets are still far more than the emerging markets of the world.

Access to healthcare still remains a global issue:

Despite so much of progress of the global pharmaceutical industry, access to healthcare still remains an issue, besides others, even in some of the developed markets of the world. The waiting period of a patient just to get an appointment of the doctor is increasing fast. Even in the US about 47 million of US citizens still are not covered by insurance, besides many more of them who remain underinsured.

Global pharmaceutical industry is still considered a part of the problem:

Despite meeting the unmet needs of the patients through intensive research and development initiatives and various global access programs for the needy and the downtrodden, the civil society all over the world, including in the developed countries, still believes that the pharmaceutical industry is a part of the global healthcare problems, though relatively more in the developing and the least developed economies of the world. These perceptions are mainly due to high costs of patented drugs, high research expenditure for low value added drugs and seemingly unethical marketing practices of the industry across the board with varying degree.

Conclusion:

The pharmaceutical industry, the ultimate savior in the battle against disease, is now passing through a critical phase both locally and globally and both in terms of its image and capacity to deliver newer medicines ensuring their affordable access, the reason of which may vary from country to country.

Be that as it may, the industry has been making significant contribution to the humanity to meet the ever increasing unmet needs of the patients. However, expectations of the stakeholders are also growing and justifiably so. There is no time for the industry, in general, to ponder much now or rest on the past laurels. It is about time to walk the never ending extra mile, for the global patients’ sake.

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.

Envisaging ‘five emerging key strategic changes’ in the Indian Pharmaceutical Industry

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In India, the domestic pharmaceutical market has clocked a CAGR of around 13% to 14% since the last five years. Currently, the market is dominated by the drugs for mass ailments. However, such trend has already started showing a shift towards ailments related to the life-style of patients. This emerging trend is expected to fast accelerate in future.All such factors put together, driven by the following key drivers for growth backed by strong logistics support and hopefully improving healthcare delivery system are expected to contribute significantly towards faster growth of the Indian pharmaceutical industry, as we move on.Key growth drivers:

The growth drivers may primarily be divided into two categories:

- Local and
- Global

Local:

• Rapidly growing more prosperous middle class population of the country.

• High quality, cost effective, domestic generic drug manufacturers who will have increasing penetration in both local and emerging markets.

• Rising per capita income of the population and in-efficiency of the public healthcare system will encourage private healthcare systems of various types and scales to flourish.

• Expected emergence of a robust healthcare financing/insurance model for all strata of society.

• Fast growth in Medical Tourism.

• Evolving combo-business model of global pharmaceutical companies with both patented and generic drugs boosting local outsourcing opportunities.

Global:

Global pharmaceutical industry is going through a rapid process of transformation. Cost containment pressures due to various factors are further accelerating this process. Some of the critical effects of this transformation process like Contract Research and Manufacturing Services (CRAMS) will drive growth of many Indian domestic pharmaceutical players.

Expecting the need for ‘New Strategic Changes’ of radically different in nature:

The impact of many of these evolutionary changes is being felt in India already. However, some more radically different types of changes, which the industry has not experienced, as yet, are expected to be felt as the country moves on to satisfy the desired healthcare needs of its population while fully encashing the future growth opportunities of the Indian pharmaceutical industry.

Five ‘New Strategic Changes’ envisaged:

Five new key strategic changes, in my view, will be as follows:

1. As the country will move towards an integrated and robust healthcare financing system:

• Doctors will no longer remain the sole decision makers for the drugs that they will prescribe to the patients and the way they will treat the common diseases. Healthcare providers/ medical insurance companies will start playing a key role in these areas by providing to the doctors well thought out treatment guidelines.

• For a significant proportion of the products that the pharmaceutical companies will sell, tough price negotiation with the healthcare providers/ medical insurance companies will be inevitable.

• Health Technology Assessment (HTA) or outcome based pricing will play an important role in pricing a healthcare product.

2. An integrated approach towards disease prevention will emerge as equally important as treatment of diseases.

3. A shift from just product marketing to marketing of a bundle of value added comprehensive disease management processes along with the product, will be the order of the day

4. Patents will be granted on truly innovative medicines and incremental innovation to be protected within the patent life of the original product only or separately for a much lesser period.

5. Over the counter medicines, especially originated from natural products for common and less serious illness, will curve out a larger share as the appropriate regulations will be put in place.

Conclusion:

With the above changes in the ball game of the Indian pharmaceutical industry, it may not be easy for the local players to adapt to such changes sooner and compete with the global players on equal footing. Those Indian Pharmaceutical companies who are already global players on their own rights, will be well versed with the nuances of this new game, within the country. These domestic companies, in my view, will offer a tough competition to the global players, especially, in the generic space.

However, so far as other domestic players are concerned, the new environment could prove to be a real tough time for them, further accelerating the process of consolidation within the Indian pharmaceutical industry. So the ‘writing on the wall’ appears to be ‘prepare now’ or ‘perish’.

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.

An image makeover is in progress in the global pharmaceutical industry.

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At the beginning of 2009, Andrew Witty, the young head honcho of Glaxo SmithKline (GSK) initiated a one CEO tirade to recognize the global poor as a stakeholder of the global pharmaceutical industry. The industry that has been much maligned over a period of time, despite its yeoman contribution to the mankind, for aiming its drug discovery and delivery more often at the rich patients and not at the sick poor of mostly the developing and underdeveloped nations of the world.
Walking the talk:
Witty perhaps wondered and questioned why the poor population must share disproportionately the disease burden of the world. As the saying goes, ‘the proof of the pudding is in the eating’. Witty walked the talk and announced:

1. GSK medicines will be available in the least developed countries (LDC) of the world at 25% of their price in the United Kingdom (U.K).

2. 20% of profits from these medicines will be re-invested for various projects in those countries.

3. GSK will put 800 potential drug patents in a ‘patent pool’ to find cures of neglected, mainly, tropical diseases.

4. Scientists will be able to share the Research Center of GSK located at Tres Cantos in Spain for this purpose.

Will other global pharmaceutical players join in?

Andrew Witty, it appears, nurtures a very keen and very real desire to change the public image of the global pharmaceutical industry through transformation of its decade long culture and setting some of these path breaking examples, which only bravehearts can follow. However, many still feel, “Improving the greedy and uncaring image of the pharmaceutical industry is indeed a tough call.”

It has been reported in the media, during his announcement for the ‘patent pool’, the GSK CEO, in fact threw a challenge to other global pharmaceutical players to join him. What resulted thereafter was a bit of an anti-climax though with a very lukewarm response from others and Andrew with a sense of perhaps despair commented, “It has caught them a bit by surprise because we didn’t go around talking to people at the time, and they’ve had to come up this curve from zero.”

The Guardian in a very recent article on Andrew Witty, quoted him in the same context of extending access to modern medicines to the poor of LDCs, “he’s encouraging Indian companies to knock off its on-patent meds for sale in poor countries, as long as they make quality products and asks GSK for a license, which it will give royalty-free.”

In the same article, The Gurdian wrote, “He’s calling on every foreign company that makes profits in Uganda to cut its prices there”. “I don’t just mean drug companies,” Witty told the newspaper -”everybody.”

It does not cost much:

The GSK CEO admits that he is not losing much on his price cuts in the least developed countries. Uganda market of GSK is very small with turnover of about £9 million a year. The total profit from the LDCs is less than £5 million. “Those sorts of sums are like the 1p coins people don’t trouble to pick up off the pavement for a company with revenue of £24bn and a stock market valuation of £60bn,” he commented.

Conclusion:

Despite not too many encouraging responses being forthcoming from others, it is indeed admirable that a top global pharma company head honcho is setting such tough goals for himself in particular and the industry in general. The question that flows from here, even reading all these:

Are you kidding Andrew Witty? Do you really mean all these? Or it is another smart global pharma CEO hankering for just cheap publicity?

Seeing you Andrew Witty, though long ago, in flesh and blood, my heart says, you are possibly not made of that stuff to befool the world on this pressing issue of the world, being at your wit’s end.

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.

‘Swine Flu’ – why create so much of scare to disturb public life?

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Why has so much of scare been created on ‘Swine Flu’ in India? Who are responsible for creating and spreading such panic?Any attempted answers to these question perhaps will remain baffling to many of us when we read that out of the total population of India, 1159 cases of ‘Swine Flu’ have been reported with 17 cases of death, as on August 12, 2009.Deaths due to other communicable diseases, including seasonal Flu, are far more than ‘Swine Flu’:

While looking at the above simple statistics, I wonder why we all fail to create a fraction of such awareness campaign for other almost equally infectious diseases in India, like malaria, tuberculosis, measles, and diarrhoea.

It is important to note, WHO reports that the seasonal influenza causes about 250,000 deaths per year. Deaths due to some other communicable diseases are also very significant and are as follows:

1. Tuberculosis: 365,000

2. Measles, Diphtheria: 287,000

A mad rush for H1N1 screening and test:

Due to such scare and panic, only in Mumbai 3,768 persons showed up for H1N1 screening in various Government hospitals just in one day on August 11, 2009 between 9 am and 5 pm. After screening all these people, only 448 individuals were identified for H1N1 test and only 14 of them were quarantined.

Awareness and preventive guidelines are necessary – without creating a mass hysteria:

Adequate awareness and preventive guidelines are absolutely necessary for any such disease without creating panic. Has H1N1 infection been used as a competitive tool, just as politicians very often do, to achieve relative competitive prowess by some? Highlighting each death due to H1N1 infection as administrative inefficiency and by creating a public scare in that process, no meaningful public health purpose can possibly be served, excepting perhaps attracting the eyeballs.

‘Swine Flu’ – reported to be a very low fatality disease:

2009 ‘Swine Flu’ pandemic is indeed a global outbreak of a new type of virus identified in April 2009 as H1N1. This strain of Flu virus is believed to be a mutation of four types of Flu viruses, one is usually endemic in human, the second one is endemic in birds and the other two are endemic in pigs or swine. This virus like many other infectious diseases, is usually transmitted from human to human.

The incidence worldwide:

Worldwide, out of over 1,62,380 H1N1 positive cases in 168 countries, 1,154 deaths have taken place as of August 4, 2009. Against this number 250,000 deaths per year take place due to seasonal influenza, as stated above . This vindicates that the fatality rate of this disease is indeed quite low, as of now. This percentage may even be lower, if those deaths are excluded, which were due to other conditions and complications not directly related to H1N1 infection.

All countries by and large, are affected by the ‘Swine Flu’ pandemic. WHO’s America’s region, where the outbreak was first detected, reports highest number of deaths with 1,008, followed by 65 deaths by its South-East Asia region, 41 deaths in Europe and 39 in Western Pacific region.

‘Swine Flu’ – reported to be a self limiting disease:

It has been reported that ‘Swine Flu’ is mostly a self-limiting disease. Clinical studies have confirmed that drugs like ‘Tamiflu’ reduce the duration of illness by a couple of days. The symptoms of the disease are moderate. Complete recovery from the disease has also been reported to be common with no future complications.

Panic related to H1N1 is unnecessary and avoidable:

Unfortunately ‘over-awareness’ and over communication of ‘possible fatality’ of the disease have lead to an unnecessary panic in India, especially, around the disease affected regions. Due to such panic people are running around with any slight ‘flu-like’ symptoms, crowding the H1N1 test centres and hospitals where the chances of getting infection by a non-infected person from others infected with H1N1 virus will be many times more.

Strain on scarce medical resources:

This mad rush, on the other hand, is putting unnecessary strain on the scarce medical resources of those towns and cities where the incidence of H1N1 infection is relatively more . Schools, shopping malls are being closed down and many important programs are being postponed. Migration of people from infected to non-infected places is further jeopardising the situation.

Conclusion:

Both tangible and intangible losses created out of ‘Swine Flu’ scare are bound to be quite significant. Who will take the responsibility of creating this nightmare?

We have our usual ‘punching bag’, the Government of course, to keep on bashing for any such issues totally forgetting our own responsibilities, individually or collectively. There is a silver lining though. A sense of responsibility, at last, appears to be slowly dawning on to those who really matter. Those who had ignited this fire of fear are now trying to douse it by themselves and in the best way as they possibly can. Obviously after much damage has been done. I take it as ‘better late than never’. But the moot question will still haunt many. Have we learnt anything out of this artificial crisis created through a real panic of H1N1 infection? Was it necessary? Has it served any meaningful purpose to the common man in general?

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.

Changing pharmaceutical marketing environment demands a change in mindset for a new strategic direction.

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Will the Tsunami of change hit India too?
In the matured markets of the global pharmaceutical industry, individual doctors are no longer the prime target customers. Healthcare providers, patient advocacy groups, pharmacy benefit managers, clinical assessment authorities etc have already emerged as key decision makers for use of various branded or generic medicines and other kind of healthcare facilities/ support for the patients.In India even today individual doctors are the prime target customers for the pharmaceutical companies as, by and large, they are the key decision makers for usage of medicines and other healthcare facilities for the patients.

However, a distinct change, albeit slowly though, is now noticeable within healthcare financing system in India. Slow but gradual emergence of healthcare providers with medical insurance and other related products, patient advocacy groups, standard treatment guidelines etc, are expected to bring in a radical change the way current pharmaceutical marketing strategy is formulated, which continue to revolve round the doctors, mainly. The small ripples of change, blessed by adequate dose of the Government’s financial policy reform measures, may soon get converted into a Tsunami of change, destroying the current pharmaceutical business strategy directions of majority of the companies. Rapid increase in the number of healthcare providers and other related stakeholders with attractive schemes for various strata of the civil society, will herald the emergence of very powerful groups of negotiators for products’ price and other healthcare related services. These groups will be capable to very strongly and significantly influence doctors’ products and other treatment choices.

Marketing will be a ‘composite value delivery system’:

In addition, during the coming years of post product patent regime in the country, pipelines of the domestic Indian companies for new ‘copycat’ versions of patented products are expected to completely dry up, making the price competition in the market place even more ‘cut throat’. In such type of environment Indian pharmaceutical companies will be under tremendous pressure to provide additional composite value, not just the physical products, as differential offerings to the patients, doctors, healthcare providers and other stakeholders, in and around the related disease areas. Ability to deliver such composite differential value along with the product will enable a company to acquire the competitive cutting edge.

Required leadership and managerial skill sets will be quite different:

In the new environment required skill sets of both the leaders and the managers of the Indian pharmaceutical companies will be quite different from what it is today. This will not happen overnight though, but surely gradually.

Skill requirements:

Leaders and managers with only individual functional expertise like, R&D, manufacturing, marketing, regulatory, finance etc will no longer be successful in the new paradigm. To handle new types and groups of customers, the leaders and managers will need to ensure:

• Multi-functional expertise by rotating right people across the key functional areas

• Knowledge of ‘Pharmaco-economics’ and/or ‘health technology assessment’ (HTA)

• Ability to interpret patients’ clinical benefits against cost incurred by the payors to achieve the targeted clinical outcome, especially in the areas of new products

• Insight about the thought pattern of the healthcare providers and other customers or influencers groups

• Speed in decision making and more importantly ability to take ‘first time right’ on the spot decision, which can make or mar a commercial deal.

Managing the phase of transition:

During the ensuing phase of transition in India, pharmaceutical companies should:

• Clearly identify, acquire and hone the new skill sets, which would drive the changing scenario

• Get strategically engaged with the existing public/private healthcare providers and health insurance companies like, Mediclaim, ICICI Lombard, large corporate hospital chains, retail chain chemists and others, proactively

• Drive the change, instead of waiting for the change to take place

• Ensure that appropriate balance is maintained in both types of marketing strategies, in innovative ways.

Conclusion:

Indian pharmaceutical industry has been trapped in a difficult to explain ‘strategic inertia’, as it were, since long. It is high time now to come out of it and face the change upfront boldly and squarely to translate this challenge into a possible growth opportunity. Global pharmaceutical companies are now gaining expertise in the new ball game in the developed markets of the world. If majority of the Indian pharmaceutical companies, who are not yet used to handling such change, are caught unaware of this possible future trend, the tsunami of change could spell a commercial disaster to them. However, I strongly hope that this new and yet another challenge of change will be met with a clear and well thought out strategic initiatives to give a further boost to the growth engine of the industry.

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.

Europe: now emerging as a more preferred market for the domestic Indian Pharmaceutical Industry

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Since almost last 30 years the Pharmaceutical Industry of India has been a net foreign exchange earner. Deutche Bank Researchindicates that over the last ten years the export surplus has widened from EUR 370 million to EUR 2 billion.Around 80% of these pharmaceuticals manufactured in India are sold to the US and Europedriven by higher purchasing power of the people in those countries and also due to recent regulatory changes towards greater cost containment initiatives by the respective governments.
Europe – a preferred destination for Indian Pharmaceutical companies:

In the quagmire of global recession, prompted by increasing pricing pressure with consequent pressure on the bottom-line, many Indian pharmaceutical companies have started increasing their focus on Europe. The European generics market is now growing faster than overcrowded US generics market.

Top domestic Indian pharmaceutical Companies like Ranbaxy, Sun Pharma, Dr. Reddy’s Laboratories (DRL), Glenmark, Wockhardt and Aurobindo whose performance is highly dependent on their revenues from the US and Europe perhaps will need to have a sharper look at both western and eastern Europe.

It has been reported that because of higher volume penetration of over 55% of generics pharmaceuticals in Europe, which is significantly higher than US, Europe offers an attractive and better growth opportunities to the Indian pharmaceutical companies in the medium to longer term. Companies like Ranbaxy, Wockhardt and Aurobindo have already reported to have started showing higher revenue growth in Europe than USA.

Major merger and Acquisition (M&A) initiatives of the Indian pharmaceutical companies in Europe augur well towards this direction. Ranbaxy has already acquired companies in France, Belgium, Romania and Zydus Cadila in France. DRL purchased Betapharm in Germany.

Inorganic growth will demand a more cautious approach:

However, the path of M&A by Indian pharmaceutical companies should be treaded with more caution. The case in point is Wockhardt, which grew with a scorching pace of over 30% on an average for several years in the recent past driven by its inorganic growth strategy. In 2006-07 Wockhardt acquired two companies in Europe, one in Ireland and the other in France. Unfortunately, the company could not manage its rapid growth through such M&A as efficiently for long and got entangled in a debt trap of around Rs. 34,000 crore in that process.

Converting problems into opportunities:

Global financial meltdown throws open an opportunity for the Indian pharmaceutical companies to acquire the distressed specialty pharmaceutical companies at a very competitive price in Europe. Many small pharmaceutical companies in Europe are now looking to sell their facilities because of difficulty in maintaining their business arising out of higher operating costs.

In such a scenario after acquiring a company in those countries, the Indian acquirer will have an opportunity to transfer the manufacturing operations to India, where the costs are much lower, keeping just the marketing operations there.

A report from The Economic Times (ET) indicates that Pharmaceutical majors like Zydus Cadilla are looking for acquisition in Spain and Italy and Glenmark in the Eastern Europe. Kemwell of Bangalore has recently acquired the manufacturing plant of Pfizer located in Sweden and has expressed intention to shift their manufacturing operations to India to concentrate only on marketing with the acquired local infrastructure.

Just at the same time and for the same reasons many global pharmaceutical companies plan to outsource their manufacturing requirements from India and China retaining the R&D and marketing operations with them.

Increasing attention on Eastern Europe:

According to PMR, the Polish Market Research company, countries like Ukraine, Bulgaria, Turkey, Russia and Romania are quite attractive for pharmaceuticals business in the Eastern Europe.

In that part of the world, Russia, Romania and Ukraine have been dominating in terms of sustained high growth since last five years. Acquisition of a local company will provide the best option for quick entry into these markets, recommends PMR.

Conclusion:

Global financial meltdown has thrown open many doors of opportunities for rapid entry into both eastern and western European markets by the Indian pharmaceutical companies for better future growth potential. I am sure the domestic pharmaceutical companies will carefully evaluate these opportunities to take appropriate action to catapult themselves to a higher business growth trajectory in the years to come 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.

Why should India implement Regulatory Data Protection (RDP) – An analysis

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To effectively address the healthcare needs of the nation and to improve access to modern medicines to a vast majority of the population, just discovery of a New Chemical/Molecular Entity (NCE/NME) or a vaccine is not sufficient. The journey from mind to market is quite a long haul process, uncertain, expensive and a tortuous one.From patients, innovators or drug regulators perspective impeccable quality, high safety and efficacy standards of all drugs are absolutely essential. To achieve these critical objectives, volumes of regulatory data require to be generated through extensive pre-clinical and clinical trials.Just like Patent Regulatory Data also need to be protected to encourage innovation:

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.

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.”

Benefits to the Indian Pharmaceutical Industry:

Research is a key driver for the Pharmaceutical Industry. Scientists prefer to work in research laboratories in those countries which provide full-fledged protection to IPRs. RDP is one of these Intellectual Property Rights. Reversal of brain drain and retention of scientific talents will be helpful to developing economies, like India to intensify R&D efforts.

Indian research based pharmaceutical companies, who are now globalising their business, are already engaged in partnerships with established foreign research based companies, as reflected in agreements between Ranbaxy and GlaxoSmithKline and earlier Dr. Reddy’s Laboratories with Novartis and Novo Nordisk. Our own scientists, therefore, need RDP to protect their Intellectual Property as many Indian pharmaceutical companies have substantially increased their investments towards R&D .

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:

A bogey is raised to create an impression that RDP provisions will act as a barrier to the development of generics, resulting in the erosion of generics market. Possible decline in export market is also highlighted. 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 ‘evergreening’ – a myth:

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 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.

The above 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.