Does India need an equivalent of ‘The Physician Payment Sunshine Act’ of the US for transparency in pharmaceutical marketing?

Currently a strong and palpable public sentiment against corruption has engulfed India albeit more than what we witness in movements like ‘Occupy Wall Street’ against systemic corruption not only in the US but in a large number of cities across the world.

Long suppressed public sentiment against corruption is fast spreading like a wild fire in India and has now become all pervasive and almost irreversible, as it were.

That said, this strong sentiment is not just against corruption, but also for greater transparency and clean governance both in the government and corporate sectors of the country.

In a situation like this, there is a wide spread belief within the civil society not just in India, but across the world that the pharmaceutical companies try to skew the ‘prescription decision making process’ of the doctors towards their respective brands largely through different types of allurements and not based solely on robust health outcome criteria.

The key reason:

The entire issue arises out of the key factor that the patients do not have any say on the use/purchase of brand/brands that a doctor will prescribe.

It is generally believed by the civil society that doctors predominantly prescribe mostly those brands, which are promoted to them by the pharmaceutical companies in various ways.  Thus, in today’s world and particularly in India, the degree of commercialization of the noble healthcare services, as reported often by the media, has reached a new high, sacrificing the ethics and etiquette both in medical and pharmaceutical marketing practices in the rat race of unlimited greed, want and conspicuous consumption.

Growing discontentment:

Many within the civil society feel, as a result of fast degradation of ethical standards, moral and the noble values, just in many other areas of public life, in the healthcare space as well, the patients in general have started losing their absolute faith and trust both on the medical profession and the pharmaceutical companies, by and large. However, health related multifaceted compulsions do not allow them, either to avoid such a situation or even raise a strong voice of protest against the vested interests.

Growing discontentment of the patients both in the private and public healthcare space in the country, is being regularly and very rightly highlighted by the media all over the world, including reputed medical journals like, ‘The Lancet’ to help arrest this moral and ethical decay with demonstrable and tangible proactive measures.

A global issue, not just local:

For quite some time from now this issue has indeed become a global phenomenon. Many countries, including India, have seriously taken note of such examples of socioeconomic decay.

Just the other day, the November 3, 2011 edition of ‘The Guardian’ reported, “British drugs giant GlaxoSmithKline has agreed to pay $3bn (£1.9bn) to settle a series of old criminal and civil investigations by the US authorities into the sales and marketing of some of its best-known products”.

The Scenario in India:

The current scenario in India though not very much different, in terms of seriousness of the issue, from what is being reported in the US, the evolving regulatory standards in the US on this subject are definitely more robust and far superior to what we see India.

In India over 20, 000 pharmaceutical companies of varying size and scale of operations are currently operating. It has been widely reported in the media that the 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 reportedly involve almost all types of their customer groups, excepting perhaps the ultimate consumer, the patients.

It has been well reported that industry’s gifts to physicians in India can range from expensive cars, dinners in exotic locations, pricey vacations at various places of interest of the world and sometimes with the doctors’ families to hefty consulting and speaking fees.

Unfortunately in India there is no single government agency, which is accountable to take care of the entire healthcare needs of the patients and their well-being, in a holistic way.

The pharmaceutical industry of India, in general, has expressed many a time, the need for self-regulation of marketing practices in the absence of any regulatory compulsion, as is not uncommon in many other countries of the world, in various ways.

Be that as it may, after a protracted debate on the alleged ‘unethical marketing practices’ by the pharmaceutical companies, in May 2011, the Department of Pharmaceuticals (DoP) came out with a draft ‘Uniform Code of Pharmaceutical Marketing Practices (UCMP)’ to address this issue squarely and effectively in India. It has been reported that the final draft of UCMP is now lying with the Ministry of Health and Family Welfare of the Government of India for its clearance.

This decision of the government is the culmination of a series of events, covered widely by the various sections of the press, at least, since 2004.

However, many activists groups and NGOs still 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.

“Market malpractices is a barrier to healthcare access”: The WHO report of 2006:

A 2006 report of the ‘World Health Organization (WHO) and ‘The Ministry of Health and Family Welfare, Government of India’ titled ‘Options for Using Competition Law/Policy Tools in Dealing  with Anti-Competitive Practices in Pharmaceutical Industry and Health Delivery System’ states:

“The right to health is recognized in a number of international legal instruments. In India too, there are constitutional commitments to provide access to healthcare. However despite the existence of any number of paper pledges assuring the right to health, access to health remains a problem across the world”.

“There are several factors that are responsible for such deprivation. Market malpractices in general, and in particular, anti-competitive conduct in the pharmaceutical industry and the health delivery system are also among them.”

The scenario in the US:

Like in India, a public debate 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, making disclosure of all payments made to the physicians by the pharmaceutical companies’ is being made mandatory by the Obama administration, as a part of the new US healthcare reform process of the last year.

Some global pharmaceutical majors have set examples by taking absolutely voluntary measures to make their relationship with the physicians transparent. 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 followed suit and so are many other large companies like, Pfizer, GSK, AstraZeneca and Johnson & Johnson.

Cleveland Clinic and the medical school of the University of Pennsylvania, USA are in the process of disclosing details of payments made by the Pharmaceutical companies to their research personnel and the physicians. Similarly in the UK 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.

The New York Times (NYT) in its April 12, 2010 edition in an article titled, “Data on Fees to Doctors is Called Hard to Parse”, reported that though some big pharmaceutical companies have started disclosing payments to doctors who act as consultants or speakers, many still find it far too difficult to follow the money trail.

NYT reported in the same article, “Senate researchers have found that some prominent doctors at academic medical centers have failed to disclose millions of dollars in drug company payments, despite university requirements that they do so. Federal prosecutors say some payments are really kickbacks for illegal or excessive prescribing”.

‘The Physician Payment Sunshine Act’:

To address this issue effectively in the US, ‘The Physician Payment Sunshine Act’, which was originally proposed in 2009 by Iowa Republican Charles Grassley and Wisconsin Democrat Herb Kohl, became a part of the US healthcare law in 2010. This Act came as an integral part of the healthcare reform initiatives of President Obama to reduce healthcare costs and introduce greater transparency in the system.

The Act requires all pharmaceutical and medical device companies of the country to report all payments to doctors above US $10. As stated earlier, the industry’s gifts to physicians in the US, reportedly, can range from expensive hospitality/dinner in exotic locations, pricey golfing vacations in various places of interest to consulting and speaking fees. After the Act comes in force with all its rules in place, failure to provide such details will attract commensurate penal provisions.

However, on November 1, 2011 Reuters reported that the Department of Health and Human Services of the US Government missed the October 1, 2011 deadline for drafting the regulations for ‘The Physician Payment Sunshine Act’ to outline procedures for the concerned companies for reporting the requisite information and sharing the same with the public.

US health officials will now delay the enforcement of the Act to ensure that they can implement the statutory goals of the Act with minimal regulatory burden on the pharmaceutical and the medical device companies.

Last year, ‘The New York Times (NYT)’ in its April 12, 2010 edition commented that come 2013, under the new ‘The Physician Payment Sunshine Act’, disclosure of such database will become mandatory for all pharmaceutical and medical device makers, who will then be subjected to stricter disclosure requirements aimed at making their marketing practices much more transparent.

Conclusion:

In the US, ‘The Physician Payment Sunshine Act’ is now in place, though its effective implementation has got delayed. It appears that Obama Administration, with the help of this new law, will make the disclosure of payments to physicians by all pharmaceutical and medical device companies transparent and effective as the rules and procedures for the same are being worked out.

If President Obama administration can take such an important regulatory step with the enactment of ‘The Physician Payment Sunshine Act’ to ensure transparency in pharmaceutical marketing practices, will Dr. Man Mohan Singh government stay much behind in taking similar measures or give the self-regulatory mechanism, as is being charted by the Department of Pharmaceuticals, one last chance?

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.

85% of the patented new drugs have therapeutic equivalents…they do not increase the cost of treatment for the common man: Points…Counterpoints

Affordability of patented drugs has become a major controversial and at the same time a very sensitive issue in the healthcare space of India, just as in many other parts of the world. The government, the NGOs and other stakeholders, on the one hand, seem to be quite concerned about it. Innovator companies, on the other hand, also have quite robust arguments in their favor.

Meanwhile, the daily newspaper ‘DNA’ published a report on June 15, 2010 with a headline, “NPPA may cap cancer drug prices via Para 10’.

Let us now try to go through the points and counterpoints of this raging debate.

The basic reasons of concern:

The key points for this concern, I reckon, is based on the following two beliefs:

1. All our citizens should have access to all new drugs
2. All these new drugs are essential to treat most of the related disease conditions

Points in favor of free pricing for patented new drugs:

- Price is a function of the value that a patented new drug will offer to the patients. The price of new drugs will, in addition, include components of the cost incurred by the innovators towards research and development, to offer these products to the patients. This is absolutely essential to ensure continuous investment towards R&D by the innovator companies to meet the unmet needs of the patients.

- It has been reported that currently only 2.3% of the Indian Pharmaceutical Market (IPM) will represent drugs, which have no therapeutic equivalent. This means over 97% of the IPM constitutes of medicines, which have one or more therapeutic equivalents.

- So far as the patented products are concerned, over 85% of all those will have therapeutic alternatives. Empirical evidence suggests that just around 15% of the patented molecules have significant therapeutic advantages over existing drugs and cannot be replaced.

- Beta-lactam, Cephalosporin and Quinolone group of antibiotics are still relevant today and will remain for many more years. So are the likes of Beta Blockers, Calcium antagonists, Ace inhibitors, Proton Pump inhibitors and Statins.

- Therefore, all patients with any common disease profile will have adequate and a good number of cheaper treatment options with the generic drugs. As all new drugs are not essential to treat all related disease conditions, generic and patented medicines should co-exist to cater to the healthcare needs of patients of all income groups. Those who can afford to pay extra for the incremental value of such patented drugs should also have an option.

The Counter points:

- The opponents of the above argument raise the counter question, “if 85% of the patented drugs will have appropriate therapeutic equivalents, why then the pharmaceutical companies spend such a huge amount of money and other resources towards R&D to invent molecules, which do not add significant and substantial value to the existing ones to treat patients? Rationalization of such avoidable R&D expenditures will help reducing the price of even path-breaking patented molecules for the treatment of many disease conditions of the ailing patients”

- In this context ‘Australian Prescriber (2004; 27:136-7)’ commented:

“The patent system, which assumes that investment in the development of new drugs, is so important that the principles of the free market should be abrogated to reward pharmaceutical companies with a legally enforced period of protection from competition”.

- NGOs with a differing view point ask, “Many patented products are still not available in India, does the medical profession in the country find themselves seriously handicapped for not having access to these drugs?’

- This group puts forth the counter argument, “patent protection is based on the fundamental belief that for continuing investment to invent newer drugs, innovations must be adequately rewarded through appropriate protection of the patents. Thus patent protection should only be given to those innovations for which no therapeutic equivalents are available.”

Conclusion:

A die-hard protagonist for fostering innovation commented, though the exclusivity for a patented drug given to an innovator would last for 20 years, the real commercial benefits will be available for just around 10 years, that too after spending a fortune towards R&D. Whereas, post patent expiry, the commercial benefits to the generic manufacturers (virtually spending nothing towards R&D) for the same molecule will last in perpetuity…for the 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.