Access to medicines in India: feedback from a gov’t consultation on compulsory licensing

India’s Department of Industrial Policy & Promotion (managed by the Ministry of Commerce and Industry) recently released a Discussion Paper on Compulsory Licensing and invited feedback from civil society groups, industry, academia and other stakeholders to guide their formulation of a compulsory licensing policy.

The Discussion Paper expressed concern regarding the availability of new products and technologies in India, including medicines and other pharmaceutical products, and seeks to explore whether compulsory licensing could be a viable solution.

Many of the submitted comments, including those of foreign business lobbies, warned that a proposal to allow government-owned or private companies to manufacture products and technologies patented by other companies, to ensure they are not in scarce supply, could discourage overseas investment in India.

Of particular interest was a submission by the Organization of Pharmaceutical Producers of India, which noted that:

Even a prima facie analysis of the situation in India would make it apparent that patents are not the primary cause for poor access to medicines in India.  Sales of patented products account for much less than 1% of the Indian Pharmaceutical market.

Thus, compulsory licensing of patented medicines can have no meaningful impact on improving access to medicines for the vast majority of the Indian population who lack the financial capability to pay for even generic, off-patent, medicines that comprise even more than 99% or so of the Indian Pharmaceutical market.

Over the past several years, the experience in most middle and low-income countries has been that private-public partnerships and affordable publicly supported health insurance do much more to improve access to medicines.

We do not believe that compulsory licensing of patented inventions is a sustainable or viable course of action to address India’s healthcare challenges.   Proposals to promote the use of compulsory licenses could inhibit technological development in the pharmaceutical sector in India and thereby undermine efforts to make medicines and other products widely available to patients.

Other key points raised in the OPPI’s commentary included:

• The use of compulsory licensing is rarely the best policy option and cannot be a suitable tool to deal with the long-term healthcare issues confronting India.
• It has been demonstrated that patents are not a principal barrier to access to essential medicines, particularly here in India.  The World Health Organization (WHO) determined that during 2000-2007 period, India had significantly greater lack of access to essential medicines than many African countries, even though it had excluded pharmaceuticals from patent protection for almost 30 years.

The US-India Business Council (USIBC), which represents nearly 350 global companies, also expressed concern that adopting the proposed policy would inhibit the growth of intellectual property-intensive industries. It will create uncertainty and have a chilling effect on innovation and investment.  Similar views have been expressed by BusinessEurope, a European trade body, and Japan Pharmaceutical Manufacturers Association (JPMA), a drug industry lobby representing at least 68 top pharmaceutical companies in Japan.  (Source:  Livemint.com)

Backgrounder on compulsory licensing

The Council on Foreign Relations recently posted an interesting article which discusses global trade rules for intellectual property in the context of access to essential medicines.  The following is a brief overview of the article: 

In 1995, members of the WTO ascribed to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which established minimum levels of protection for member countries for products including pharmaceuticals.

WTO members were also given flexibility in how to establish their patenting systems, which allowed them to issue compulsory licenses to produce generic versions of products, including drugs, without the permission of the patent holder under circumstances such as a national emergency. But this flexibility has led to a lot of controversy. Do Hyung Kim of the University of the Houston Law Center in February 2007 says in a research guide on TRIPS that the problem is “any nation can, in theory, declare a public health emergency for questionable reasons to assign compulsory licensing for any patented drug.”

By the turn of the century, a number of emerging economies threatened to issue compulsory licenses just as they would have come under TRIPS jurisdiction, primarily as a tool in drug price negotiations.

Some experts are concerned that the inclusion of noninfectious diseases, such as cancer, diabetes and heart disease, into this little- or no-profit scenario could undermine innovation for chronic diseases, because there would be few profit avenues left for pharmaceutical companies. “Somebody’s got to pay, there’s no free lunch,” argues Fidler. With the investment climate so competitive, R&D money for a product likely to be “immediately stolen” by countries breaking patents could be a difficult sell to investors.

Read the full backgrounder at the Council on Foreign Relations site.

New Government in Thailand Supports the Role of Medical Innovation in Improving Patient Outcomes

A recent editorial in the Wall Street Journal Asia (Good Medicine for Thailand) commends recent efforts on behalf of the Thai government to improve support for drug research and development and highlights the importance of medical innovation in improving health care delivery and patient outcomes.

It appears the new government in Thailand is starting to recognize that encouraging innovation, and developing better drug pricing and delivery schemes is in the best interests of Thai patients.

Last week the government removed one of the most vocal opponents of intellectual property rights from the board of the state-owned Government Pharmaceutical Organization.  It’s a small step, but an important one for restoring Thailand’s international reputation and protecting patients’ health.

Vichai Chokeviva argued that Bangkok was acting according to domestic and international law when it allowed the government to manufacture HIV/AIDS and cancer drugs using formulas patented by Sanofi-Aventis, Abbott Laboratories and other companies.

That’s debateable, at best. The World Trade Organization says patents can be seized – after negotiation – in cases of “national emergency” or for “public non-commercial use.”  But Thailand doesn’t have an HIV/AIDS epidemic like sub-Saharan Africa, and its cancer incidence rates are average.  As for the “non-commercial use” clause, Mr. Vichai opposed the appointment of the president of Thailand’s Pharmaceutical Research and Manufacturers Association to the GPO board last month because “the private sector” is “our business competitor [our emphasis].”  Thailand also didn’t do much to negotiate with the drug companies before seizing their inventions.

Health Minister Chaiya Sasomsup, who took office in February, deserves kudos for removing the official sanction for these kinds of harmful public voices.

Mr. Chaiya understands that drug companies won’t devote significant resources to researching Thai-specific diseases if they aren’t compensated for their innovations. The Government Pharmaceutical Organization has a history of corruption and isn’t certified by the World Health Organization. It is hardly an institution to invest with more power.

Far better to encourage world-class, private drug companies to invest in Thailand and work with the government on better drug pricing schemes and delivery programs. Mr. Chaiya’s quiet war for property rights isn’t on behalf of the drug companies. It’s in the best interest of Thai patients.