India's Ministry of Health- Data exclusitivity not required by TRIPS and will affect

USTR seeks to influence the position of the Indian Ministry of Health

New Delhi, 7 April '08: Representatives of the United States Trade Representative(Ms. Tanuja Garde USTR, Washington D.C.) on behalf of multinational pharmaceuticalcompanies and the US government has already met with the Indian Ministry of Health.This is to try and influence a change in the Health Ministry's position that DataExclusivity is not required under Article 39.3 of the TRIPs Agreement and anamendment to the Indian Drugs and Cosmetic Act canhave a serious impact on the approval and availability of affordable, low costgeneric versions of essential drugs.

Another meeting with USTR is slated to happen this month before representatives ofthe Ministry leave for Geneva. The Indian Ministry of Health is one of the keycountry delegations at the Intergovernmental Working Group on Public Health,Innovation and Intellectual Property (IGWG) established by WHO in 2006 and whichmeets in Geneva at the end of this month to discuss and negotiate an action plan forresearch and development that prioritizes the health needs of developingcountries.

Developing countries feel that the draft action plan being negotiated in Genevashould set out several underlying 'principles' for a global strategy on health andinnovation, among them the notions that the "right to health" trumps commercialinterests, and that intellectual property rights should not become an obstacle toaccess low cost generic medicines. One such specific principle is that DataExclusivity is not required under TRIPS and also from the perspective of publichealth and access to medicines, it is preferable for developing countries not togrant data exclusivity.

India's Ministry of Health does not favour Data ExclusivityAs you may be aware the Indian Ministry of health till date has not been in favourof data exclusivity as it feels that it will interfere with the work of a governmentbody (the drug regulator) that relies on clinical trial data to approve ofaffordable generic essential drugs. It favours the alternative i.e. 'dataprotection' or the non - disclosure of clinical trial data to third parties. Thisaccording to the Ministry of Health will be TRIPS compliant and will allowcompetition to take place and thus avoid giving monopoly rights to the innovatordrug companies on the new drugs (not patented) and thus help keep a check on theirprices.

However this can change if USTR is successful in influencing the Ministry of Healthto implement TRIPS PLUS provisions. In the past, USTR has on behalf of multinational pharmaceutical companiessuccessfully pressurised many developing countries to implement Data Exclusivity,even though it is not required by the TRIPS Agreement and can seriously affectaccess to low cost essential medicines by delaying generic competition even in caseswhere the medicines are not patent protected.

WHO Report does not recommend Data Exclusivity

This position of the Ministry of Health is supported by the report of the WorldHealth Organization's Commission on Intellectual Property Rights, Innovation andPublic Health, which, states this veryclearly:

Article 39.3, unlike the case of patents, does not require the provision of specificforms of rights. [.] It does not create property rights, nor a right to preventothers from relying on the data for the marketing approval of the same product by athird party, or from using the data except when unfair (dishonest) commercialpractices are involved.

Data Exclusivity will further limit India's role in supplying essential drugs todeveloping countries

In the last decade generic production in India has emerged as crucial for the supplyof quality affordable medicines to the developing world, especially for newer drugssuch as antiretrovirals (ARVs) for the treatment of HIV. Already in 2005, the Indian Parliament under obligation to implement WTO's Agreementon Trade Related Aspects of Intellectual Property Rights (TRIPS) amended its PatentsAct to allow for the granting of pharmaceutical product patents - something Indiahad not done since 1970. Patents being granted by the Indian Patent Office foressential/life saving drugs, include newer antiretrovirals (such as Etravirine)which could prove to be crucial in the treatment of AIDS. This is already causingconcern about the future of millions of people living with HIV/AIDS dependent fortreatment on affordable generic drugs from India.

In addition to patents, data exclusivity will effectively prevent marketing approvalof essential drugs for several years even if patents applications on these arerejected, for example when a pharmaceutical does not meet the standards forpatentability (e.g. because it is not new).

Data Exclusivity i.e. a certain length of time during which the Regulatory Authorityis prohibited from relying on the available clinical trial data in order to registera generic version of the same product.

As Indian generic manufacturers are directly involved in making available affordabledrugs in India and other developing countries, patients and treatment advocacygroups are considerably concerned that a delay in registration i.e. marketingapproval of generic drugs can seriously impact the lives of people living withHIV/AIDS who face the threat of drug resistance every four years and are thereforedependent on generic manufacture in India to access newer drugs and treatment ataffordable prices.

They also remain highly susceptible to other infections; for instance HIV and TBco-infection is of increasing concern for persons living with HIV/AIDS. Access toaffordable essential drugs for opportunistic infections is also critical in ensuringlong, healthy and productive lives for persons living with HIV/AIDS.

Experience shows Data Exclusivity in other countries has effectively created amarket barrier that is difficult for generic manufacturers to overcome.

Public Interest Groups oppose Data Exclusivity

In the last few years, several public interest groups including the Indian Networkfor Persons living with HIV/AIDS (INP+), the Medico Friends Circle, the Jan SwasthyaAbhiyan (Peoples Health Movement), the Global AIDS Alliance, Torchbearers (mentalillness advocacy group), MSF's Campaign for Access to Essential Medicines, theBangalore HIV & AIDS Forum and the Lawyers Collective HIV/AIDS Unit have alsowritten to the Prime Minister and the health ministry outlining their opposition toData Exclusivity for drugs as it can have a serious impact on the approval andavailability of generic versions of essential drugs in the future.

Please write to the Ministry of Health:

Once again write to the Ministry of Health to take into consideration public healthneeds of patients in India and other developing countries and actively provideleadership in ensuring that intellectual property does not hinder access to drugs.

Please urge the government to not consider Data Exclusivity proposed by USTR andensure that generic competition remains viable and possible in India. So manypatients are depending on it for access to affordable medicines worldwide.

Write to:

Naresh Dayal
Secretary Dept. of Health and Family Welfare Ministry of Health and Family Welfare Government of India
Nirman Bhawan, New Delhi - 110 011
Tel: +91 11 23061863, +91 11 23063221
Fax: +91 11 23061252
Email: http://anywheremail.qlc.co.in/src/compose.php?send_to=secyhlth%40nb.nic.in

Aradhana Johri Joint Secretary
Dept. of Health and Family Welfare Ministry of Health and Family Welfare
146-A, Nirman Bhawan New Delhi - 110 011
Tel: +91 11 23061195,
Téléfax: +91 11 23061842
Email: http://anywheremail.qlc.co.in/src/compose.php?send_to=aradhana.johri%40nic.in

Debasish Panda,
Joint Secretary
Ministry of Health and Family Welfare
Nirman Bhavan, New Delhi - 110 001
Téléfax: 91-11-23061447
Email: jsrch@nb.nic.in

For more information contact:
Leena Menghaney
Campaign for Access to Essential Medicines (MSF)
New Delhi, India
Tel: + 91 9811365412
Email: leena.menghaney@gmail.com

Gopa Kumar
Centre for Trade and Development
Email: gopa.kumar@centad.org

The report is available at http://www.who.int/intellectualproperty/documents/thereport/en/index.html