How is the international community looking at the recent Indian Patent Law amendment? Has India’s adoption of the product patent regime been a setback to the global campaign of improving the accessibility of medicines to the poor?
The initial reaction, looking mostly at the Ordinance that was proposed by the government, was extremely negative. The proposal included a number of provisions that were quite restrictive. The law that was actually passed by Parliament addressed some of these issues, particularly the narrowing of the grounds for patentability, which will reduce ever-greening of patents and the mandatory compulsory licence on all mailbox patents that apply to products now being manufactured in India. This will give India a lot of experience with setting remuneration for patents on medicines. Also, according to Article 92 of the Indian law, India can easily issue compulsory licences on new products if it wants to. Today, the concern is not so much about the Indian law, but the political will in India to use the compulsory licensing provisions.
India has emerged as a big exporter of generic medicines to many small countries, especially in Africa, and has helped them to fight epidemics and diseases at considerably less cost. Will the switchover to the product patent regime hamper this ability of India, once product patented medicines start entering the Indian market?
In the short run, nothing will change. But over time, it will depend upon the willingness of the government to protect its own poor. Novartis says it considers the Indian market to be 50 million people. The government will have to do something to protect the interest of the rest of the population who will not be able to afford medicines sold as a monopoly.
Will the provision of producing for export under the compulsory licensing regime, as provided in the new patent law, take care of this concern?
The Indian Parliament fixed the problem with the export provision. Drugs now in the market will be available for export. The big question is what about the new drugs that are not yet manufactured in India. If India protects its own poor, the poor in other countries will also benefit. If India does not protect its poor, other countries will have to look elsewhere for suppliers. India is not the only country that is facing a test of political will. Brazil is yet to issue a
compulsory licence. Thailand is timid. China has not issued compulsory licences. There are many countries that are unwilling to use the TRIPS (Trade Related Aspects of Intellectual Property Rights) flexibilities. At least India is starting with a large number of compulsory licences on mailbox patents, thanks to the amendments.
Do you envisage the possibility of big multinational pharmaceutical companies using the new Indian patent regime to
establish a strong monopoly in one of the biggest pharmaceutical markets, to the detriment of the poor of the world?
Of course, that is what the big pharma companies want. They not only want to charge high prices in India, a country they think of as potentially rivalling Canada or the UK as a market, but they want to eliminate India as a source of supply for cheap generics. The future
will depend upon the strength of the Indian social movement. Will the poor in India persuade their own government to protect their interests?
How can civil society organisations focus their campaigns for improving the accessibility of medicines to the poor of the world in the context of the growing product patenting of medicines under TRIPS?
The global battles have gone well. The local battles are largely ahead of us. In recent years, Brazil has threatened, but not actually issued, a compulsory licence on a drug patent. China was pressured by the European Union and the United States to forgo compulsory licences on drug patents in 2003. Thailand needs to move ahead. No member of the Bangui Agreement in West Africa has issued legal compulsory licences yet. If these countries want cheap sustainable sources of generic medicines, they will have to face up to the need for a transparent and legal framework for generic medicines.
One solution may be the creation of a global patent pool for essential medicines. The local social movement could pressure governments to issue compulsory licences on patent owners who do not voluntary license to the pool, and the global social movements could directly pressure patent owners to licence to the pool. By making it a big global project, it might be easier to obtain local action and buy in. |
