What is Data Exclusivity?

APPROVAL OF AFFORDABLE GENERIC MEDICINES***

5 May 2006, New Delhi - The Government of India is in the process of deciding its stand on the crucial question of amending the Drugs and Cosmetic Act, 1950. They are seriously contemplating inserting provisions in the Act, which will provide pharmaceutical companies exclusive rights over pharmaceutical data submitted by them to the Drug Controller of India for marketing approval i.e. data exclusivity.

What is Data Exclusivity?

n A new type of intellectual property right in the name of data protection, intended to provide exclusive monopoly rights to pharmaceutical companies where patents would not. Unlike what is being portrayed to the people and the media, ‘Data Exclusivity’ measures imply much more than non-disclosure of test data by the drug regulatory authority to rival pharmaceutical companies.

n Changes the current system of approval for generic medicines.

n How does it impact access to generic drugs: Provides pharmaceutical companies exclusive rights on pharmaceutical data so that they can effectively prevent the drug regulatory authorities (DRA) themselves from relying on test data already in their possession for subsequent approval of generic versions of the medicine.

n Practically, prevents DRAs from registering generic versions of a medicine for a period ranging from 5 to 10 years, unless the generic manufacturer independently carries out its own tests showing the safety and efficacy of the medicine.

n Even when a medicine is not protected by any patent, pharmaceutical companies are assured a minimum period of monopoly because of data exclusivity.

n It is the regulatory authorities that enforce data exclusivity rights. Unlike patents, the rights holder is spared the expense and embarrassment of being seen to enforce their rights in public. Public health agencies reduced to enforcing private commercial rights!!!

What is the current practice for approval of generic drugs?

As of now there are no data exclusivity provisions in Indian law. Accordingto current practice in India, generic manufacturers have to apply formarketing approval of the generic version of a medicine to the DCGI. Theyare off-course required to provide bio-equivalence studies to prove thattheir generic version of the medicine is the therapeutic equivalent to theoriginal and do not have to again submit test data regarding safety andefficacy which is already with the DCGI. For this the DCGI is entitled torely on test data submitted by the pharmaceutical company who first soughtmarketing approval for the medicine.

Why are public interest groups concerned?

· ‘Data exclusivity’ measures have the effect of limiting generic competition. Generic production of drugs has been one of the most important, reliable, and powerful forces to reduce drug prices systematically in India and other developing regions, making essential, life-saving medicines such as antiretrovirals (ARVs) for the treatment of HIV/AIDS more affordable for individuals and the health systems that serve them.

· If such data exclusivity provisions are introduced in India the Drug Controller of India (DCGI) will be barred from relying on test data, which is already in its possession in granting marketing approval to generic medicines. Instead it will be forced to ask the Indian generic manufacturer to carry out its own clinical trials showing efficacy and safety of the medicine. Theoretically data exclusivity provisions do not legally prevent generic manufacturers from generating their own test data for marketing approval. However in reality the financial resources and the time needed forconducting clinical trials for generating test data already available withthe Drug Controller creates a market barrier that is difficult for genericmanufacturers to overcome and delays the introduction of the generic drug bya number of years.

· Data exclusivity measures in other countries is already preventing drug regulatory authorities from granting approval to generic medicines up to five to ten years, seriously delaying access to affordable generic versionsof medicines. In Guatemala in February 2004, Atazanavir a drug used in HIV treatment (priced at US$ 10, 000 per person per year) received data exclusivity protection for five years under the law passed by the government. However a more affordable generic version of Atazanavir cannot enter the Guatemalan market until 2009 as drug regulatory authorities have to provide data exclusivity protection to test data related to Atazanavir. As a consequence drug Regulatory authorities in Guatemala are themselves barred from relying on it to approve of subsequent generic versions.

· Coupled with the new patent law this can easily result inan absolute monopoly regime in pharmaceuticals, seriously affecting themanufacture and availability of affordable generic drugs. Can also seriously limit the ability of the government to make use of safeguards in their patent laws to protect public health.

· Unnecessary and possible human injury associated with duplicative testing.


What can organisations and individuals do?

The government is considering amendments to the Drugs and Cosmetics Act asit is under pressure from US, and multinational pharmaceutical companies toamend the Act to include data exclusivity protection provisions (see pg 103of 2005 PhRMA "Special 301" Submission to United States TradeRepresentative).
· Write to the government of India to ask for more information on theissue and also to convey your concern on its possible decision on amendingthe Drugs and Cosmetic Act to include such provisions.
· Brief the parliamentarians and policy makers on the implications of data exclusivityMobilise public opinion against such move