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India is reckoned among the global leaders in the manufacturing of generic medicines. But, it is also held that the largest number of populace in India is living without having an access to basic medicines. The World Medicines Situation Report 2004 of the World Health Organization (WHO) pointed out that approximately 67 % of the population lives without an access to essential medicines.
One of the main reasons behind poor access to essential medicines in India is held to be the lack of buying power, which is further intensified by the poor public health delivery system. In addition to this, it is believed that public expending on research and development of medicines has also been very low.
The challenge became bigger with the modifications to the Patent Act (1970) in 2005, which needed India to abide by the international intellectual property rights obligations under TRIPS, regarding product patents.
There are many factors that lead to inaccessibility of essential medicines. These include insufficient public investment in health, poor support for research and development, unjust regulations for prices and international obligations. In India, the medicine pricing is regulated by the National Pharmaceutical Pricing Authority (NPPA) within the Department of Pharmaceuticals.
In order to provide accessibility to essential medicines to the masses, India would have to face some serious challenges, which need to be addressed on an urgent basis. Some of these can be met on national level, but some require international attention.
The main concerns to deal with are the protection and utilization of Public Funded Intellectual Property Bill (2008), Price Negotiations for Patented Drugs and Medical Devices, Evergreening of patents, Free Trade Agreements, Counterfeit Drugs and Seizure of Generic Drugs by EU.
Public Funded Intellectual Property Bill (2008) was introduced by the Ministry of Science & Technology to boost innovation and transfer of technology in institutions furnished with public fund in India. The Bill proposes for a mandatory patenting of inventions coming out of research which are publicly funded. The civil society activists and academics hold that this passage would add to the challenge of inaccessibility by blocking knowledge flows in pharmaceutical research.
Price Negotiations for Patented Drugs and Medical Devices is the other concern. A committee was founded by the Department of Pharmaceuticals to explore the likeliness of price negotiations for patented drugs and medical devices. Of late, the committee has proposed a model for negotiations of the prices of the patented drugs. The main challenge here is that the price negotiations do not conform to the safeguards in the Patent Act given under section 84, regarding Compulsory Licensing, which is integral to public health. If price negotiations do not match with price control measures, it fails to reduce prices of patented items.
Evergreening of patents cause delay in the entry of generic medicines into the market, which in turn affects the access to basic medicines. Besides, Free Trade Agreements between the North and South are also taken as a threat to access to medicines. By imposing strict standards of Intellectual Property Rights (IPRS), TRIPS has created an imbalance between the North and the South. Besides, to tackle the issue of Counterfeit Drugs, WHO-IMPACT (International Medical Products Anti-Counterfeiting Task Force) was introduced. The arrangement seems simple on its face value, but it crosses the limits of mandated areas of safety, quality and efficacy of medicines.
Seizure of Generic Drugs by EU was the major blow that generic drug industry of India faced last year. As many as 16 consignments were seized in transit, an incident which set an example of the extraterritorial practice of laws by EU nations in the name of safeguarding the growing world.
It can be said that to emerge winner in this scenario to provide access to essential medicines to the populace, it is important to adopt a holistic stance. It’s time to understand the factors that can hinder an access to medicine in India. The issue should be considered from local, regional, national as well as international angles.
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