The global health impact of Indian FTAs with the European Union and Japan
We the undersigned wish to take this opportunity to raise our serious concerns regarding the Government of India’s on-going discussions with both the European Union and Japan on bi-lateral Free Trade Agreements and the impact this may have on continued and future access to lifesaving medicines produced by Indian pharmaceutical companies.
At the moment millions of men, women and children worldwide are dependent for the present and future health and well-being on the low cost, quality medicines produced in India. In particular millions of people with HIV are able to lead a healthy life thanks to the antiretroviral drugs produced in India. These drugs are purchased by governments, non-governmental organizations and other agencies for use in treatment programmes in Africa, Asia and South America.
For example 67 % of medicines exports from India go to developing countries and 92% of HIV/AIDS patients in low and middle income countries use generic antiretroviral drugs mostly coming from India. Approximately 50% of the essential medicines that UNICEF distributes in developing countries and 80% of all medicines distributed by the International Dispensary Association (IDA) are manufactured in India. Lesotho, buys nearly 95% of all ARVs from India and in Zimbabwe, 75% of tenders for medicines for all public sector health facilities are from India.
Here in Thailand we are particularly concerned about maintaining a continuous supply of Indian generic medicines for use in the National Health Security scheme which ensures free access to treatment for all Thais.
Several Indian generic medicines, such as efavirenz and heat-stable lopinavir/ritonavir, are supplied to the public health system under government use compulsory licenses and the National Health Security scheme would face major financial constraints should the supply line of Indian generic medicines be disrupted due to the Indian government accepting TRIPS+ provisions in any future Free Trade Agreements.
With the looming threat of these supply lines being disrupted by TRIPS+ provisions that are likely to be demanded of the Indian Government by FTA negotiators from the European Union and Japan we request that the Indian Government stand firm on their position of refusing all TRIPS+ provision that maybe included in any final agreement.
In particular we request that special care is taken to avoid the inclusion of several elements that may affect global access to the supply of current and future medicines produced by Indian pharmaceutical companies. These include the following TRIPS+ measures:
- Extension of current patent terms
- Patentability criteria – a threat to section 3d
- Extension of data exclusivity
- IP Enforcement and border controls
- Criminalisation of enforcement of patents
Extension of current patent terms: At present patents on drugs in India last for 20 years from the date of filing but it is very likely that the EU and Japan will seek an extension beyond the current 20 year period to take into account the time taken to process the patent application and to approve the medicine as safe, effective and good quality. The extra years added to the patent are extra years in which the patent holder can maintain a monopoly position and continue to charge high prices for the drug, free from generic competition.
Patentability criteria: Currently the India Patent Law has strict patentability criteria and within section 3d of this law it is clearly stated what is not an invention and therefore not patentable i.e. a new use of an old drug, or derivatives of old drugs or combinations of old drugs. Any threat to section 3d within any FTA negotiations should be combated as weakened patentability criteria will lead to “frivolous patents” that deny access to essential generic medicines for many years to come.
Extension of data exclusivity: There is a danger that during FTA negotiations there will pressure placed upon the Indian negotiators to grantmultinational pharmaceutical companies data exclusivity beyond the current 5years allowing them to maintain exclusive rights on pharmaceutical data.
This effectively prevents the Drug Controller Generals officers from relying on clinical data already in their possession for subsequent approval of generic versions of a medicine. As a result the DCGI will be unable to process an application for marketing approval of generic version of the medicine and access to a generic form is effectively blocked for many years.
IP Enforcement and border measures: Border measures that seek to detain imports or exports of good that allegedly of infringing intellectual property rights effectively block Indian generic medicines from reaching those in need in other parts of the developing world as seen in the seizure of medicines in European ports en route to Africa and Latin America. Any FTA that contains provisions on border measures will lead to an increase in such illegal seizures of Indian medicines.
Criminalisation of enforcement of patents: Currently, under Indian law, alleged infringements of a patent or copyright is a civil offence. We are concerned that both the European Union and Japan may press for criminalisation of such infringements in any Free Trade negotiations. Such a move would effectively turn the DCGI into a de facto patent police and would deter anybody, including generic companies, from challenging invalid patent.
With such threats to the pipeline of essential generic medicines for the developing world we urge the Government of India to remain firm in ensuring that in no Free Trade Agreement does India sign away her rights under international law. None of the restrictive provisions mentioned above are required under the World Trade Organization (WTO) Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), and this is reaffirmed by the November 2001 Doha Declaration on TRIPS and Public Health.
Thai Network of People Living with HIV/AIDS
AIDS Access Foundation
Alternative Agriculture Network
Friends of Kidney-failure Patients Club
Cancer Patient Network
Foundation for Consumers
The Rural Pharmacist Foundation
The Rural doctor foundation
Foundation for AIDS Rights
Thai NGO Coalition on AIDS
Drug Study Group
Biodiversity and Community Right Action Thailand, (Biothai)
Health Consumer Protection program, Chulalongkorn University
Social Pharmacy Research Unit, Chulalongkorn University
Drug System Monitoring and Development Program, Chulalongkorn University
Thai Holistic Health Foundation
Ecological Alert and Recovery - Thailand