Healthy Skepticism Library item: 7472
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Euractiv .
EU urged to support India in drug-patent battle
EurActiv 2007 Jan 16
http://www.euractiv.com/en/health/eu-urged-support-india-drug-patent-battle/article-160933
Full text:
Humanitarian aid group Médecins Sans Frontières has urged the EU to support the Indian government in a bitter legal fight against Swiss Pharma company Novartis over patented medicines.
Related Documents:
News: EU accepts compulsory licensing of pharma patents for ‘countries in need’
Background:
Other news
Pharmaceutical forum far from consensus
‘Governments have no right to cut patients…
‘Member states want to block any change…
‘Who drives demand for more information to…
Pharma platform proposes EU Medicines Research Academy
In January 2006, Novartis’s patent application on a cancer drug (imatinib mesylate) was rejected in India on the grounds that it only represented a new form of a known substance and therefore was not an innovation and not patentable under Indian law. The company filed an appeal over the patent rejection and is also challenging the Indian patent law, arguing that it violates WTO rules.
The WTO Doha Declaration on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Public Health states that “the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all”.
The EU has endorsed the WTO rules allowing compulsory licensing of patented products and processes to ensure access to affordable medicines for poor countries.
Issues:
A legal action by Swiss pharma group Novartis against the Indian government over patented drugs is raising concerns about the potential impact of the case on access to medicines in developing countries.
Referring to a European Parliament resolution of September 2005, humanitarian group Médecins Sans Frontières (MSF) is urging the EU to react to the Novartis case. It has also launched a ‘drop the case’ petition against Novartis.
The resolution stressed the importance of India with regards to access to medicine for developing countries and calls on the EU to support India in further implementing its intellectual property laws in a manner that will “create an environment that will continue to encourage and facilitate investment by the Indian generic manufacturing industry in providing affordable essential medicines for developing countries”.
Positions:
According to Novartis’s statement on the case “the best way to encourage innovation is via respect for intellectual property. We do not believe that denying patent protection for innovative medicines and promoting unlawful generic production and use within developing countries will help patients or increase their access to medical treatment. Indeed, the Indian case demonstrates the opposite.
“The tension between intellectual property rights and access to medicine is addressed by the Doha declaration offering the instrument of compulsory licenses to tackle public health problems, and Novartis supports the flexibilities offered in this declaration.”
The humanitarian group Médecins Sans Frontières fears that if Novartis wins the case, patents on new derivatives or combinations of existing drugs demonstrating no real innovation will become as easily granted in India as they are in most other countries. This would mean that Indian companies could no longer produce cheap generic drugs, which are essential for access to medicines for people in developing countries.
The MSF also regrets that the current WTO rules allowing compulsory licensing of drugs for developing countries have not improved those countries’ access to medicines. According to MSF, the WTO rules are “prohibitively complex” for the organisation to buy drugs under them and provide no incentive for companies to produce the drugs. The organisation therefore hopes that the WHO’s intergovernmental working group on public health, innovation and intellectual property will find a workable solution respecting medical R&D priorities, access to medicines and intellectual property.
The European Parliament resolution (September 2005) on strategic partnership between EU and India points out that “half of the patients who take antiviral medicines in poor countries are using medication produced in India” and “calls on the EU to support India in further implementing its intellectual property laws in a manner that will avoid barriers to the production, marketing and export of essential medicines”.
Latest & next steps:
The hearing of the case is expected to take place before the end of January 2007.
A coalition of MEPs will organise a hearing on the issue in the European Parliament on 23 January 2007.
Following the recommendations of WHO’s Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH ) an intergovernmental working group on public health, innovation and intellectual property was mandated in May 2006 to find a solution to the tension between intellectual property rights and access to medicines.
Links
EU official documents
European Parliament: European Parliament resolution on EU-India relations: A Strategic Partnership (29 September 2005) [FR] [DE]
Commission: Access to essential medicines [FR]
Industry Federations
Novartis: Novartis position – Glivec patent case in India (December 2006)
International Organisations
WHO – Commission on Intellectual Property Rights, Innovation and Public Health: Public health – innovation and intellectual property rights (April 2006)
WHO – Commission on Intellectual Property Rights, Innovation and Public Health: Intellectual property and public health [FR]
WTO: TRIPS and public health
NGOs
Médecins Sans Frontières: Q&A on patents in India and the Novartis case (20 December 2006)
Médecins Sans Frontières: Neither expeditious, nor a solution: The WTO August 30th decision is unworkable (August 2006)
Press articles
News Nature: Petition aims to maintain cheap drugs
Reuters: MSF urges Novartis to drop patents case in India
L’Humanité: Novartis veut fermer la « pharmacie des pauvres »
