India-US panel: Access to medicines may be under threat

Medicines when used appropriately can save lives. Unfortunately, huge populations of people globally do not have access to essential medicines. It is rather interesting to note that the type of patent laws of a country can completely change the access to essential medicines scene.

Which squarely means that the patent policies of a country can either be ‘people friendly’ or in other extreme and worst situations, serve the profit interests of the huge multinational drug companies.

If the patent laws of any country are not favouring big drug companies, then it is also no surprise that these laws face continuous threat from the big pharma. This in turn will affect the lives of millions in developing countries. The United States is using different tactics to increase its pressure on India to revise its patent system.

Indian patent laws have safeguards that make the price of medicines affordable. It is precisely these laws that have nourished the robust Indian generic drug companies, which slash the prices of medicines and has made India an important supplier of low-priced medicines to treat diseases such as TB, malaria, cancers, diabetes and cardiovascular disease.

In the case of medicines much needed for HIV/AIDS the prices have been slashed by 90 per cent. HIV/AIDS has been a major public health problem in several poor setting countries and when Indian generic drug companies produced medicines at such affordable prices that they became the darling of the poor countries.

No wonder that Indian drug manufacturing companies are considered as “The Pharmacy of Developing Countries”, as they supply medicines at affordable prices to around 200 developing countries all over the world.

The US, which houses most of the big multinational drug companies, wants to bring pressure on the Indian government to amend the Indian Patent Act as it is becoming a hurdle in their profit making business.

Several incidents in the recent past are an indication that the Indian government may be bending down to accommodate to the needs of the US drug companies.

The Indian prime minister’s visit to the US was a big news all over the world. But, unfortunately, it was at this visit that the US and India announced the formation of a US-India high-level Working Group on Intellectual Property.

This group will have the authority to give directions that can make changes in the Indian Patent Act. This, in turn, will affect the lives of millions in developing countries. The US is using different tactics to increase its pressure on India to reform its IP system.

Within days of Prime Minister Narendra Modi’s visit to the US, the United States Trade Representative (USTR) launched an ‘Out of Cycle Review’ of India’s patent regime that carefully targets the areas that displease US businesses without any regard to global health.

Apart from all this, the US government has set up the ‘United States International Trade Commission’ (USITC) which is an independent, quasi-judicial federal agency with broad investigative responsibilities on matters of trade with a concern for its industry.

The USITC held hearings in the US as its drug industry associations made false allegations that India had failed to comply with its obligation under the Trade-Related Intellectual Property Rights (TRIPS) agreement. The USITC launched a second investigation in October 2014, even before the report of the first investigation had been released, in order to intensify pressure on the Indian government.

According to a recent report by USITC titled “Trade, Investment, and Industrial Policies in India: Effects on the US Economy” of December 2014, the Indian “intellectual property policies, have large negative effects on (its) specific industries”. The USITC’s press release directly refers to the demand of standards of patent laws protection comparable to USA and Western European levels.

Compulsory licensing

Two major contentious issues that are expressed in the report include the provision of Section 3(d) and granting of compulsory licensing, both of which are important part of the Indian Patent Act. Section 3(d) is to prevent the practice of patent “ever greening,” which reportedly occurs when a manufacturer makes minor improvements to an existing patented medicine and tries to obtain a new patent.

Compulsory licensing is on the other hand allowing someone else to produce a patented product without the consent of the patent owner on grounds of public health emergency.

The US industry representatives, particularly those in the pharmaceutical and biotechnology sectors, consider patent barriers a substantial obstacle to doing business in India.

According to the USITC report, “US industry representatives also are concerned about the “contagion” effects on other countries of section 3(d) and compulsory license provisions in India’s law.” That is, they are worried that other countries will follow India’s lead and promulgate patent policies that undermine core business models based on incremental innovation.

For example, in 2008, the Philippines amended its patent law to add language similar to section 3(d) to describe inventions that would not be patentable. In 2012, Argentina issued resolutions that limit  patentability of derivatives of pharmaceutical products much the same way as India.

It is indeed good that India is showing the way to other developing countries with regard to framing patent laws. If Indian government succumbs to these pressure tactics then the pharmacy of developing countries will dry up and millions of patients in around 200 countries will have to face suffering and death due to lack of essential medicines.

(The writer is President, Drug Action Forum – Karnataka)