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)
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