[Commons-Law] Data Exclusivity-Action Alert

[gopa kumar]

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. According
to current practice in India, generic manufacturers have to apply for
marketing approval of the generic version of a medicine to the DCGI.  They
are off-course required to provide bio-equivalence studies to prove that
their generic version of the medicine is the therapeutic equivalent to the
original and do not have to again submit test data regarding safety and
efficacy which is already with the DCGI. For this the DCGI is entitled to
rely on test data submitted by the pharmaceutical company who first sought
marketing 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 for
conducting clinical trials for generating test data already available with
the Drug Controller creates a market barrier that is difficult for generic
manufacturers to overcome and delays the introduction of the generic drug by
a 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 versions
of 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 in
an absolute monopoly regime in pharmaceuticals, seriously affecting the
manufacture 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 as
it is under pressure from US, and multinational pharmaceutical companies to
amend the Act to include data exclusivity protection provisions (see pg 103
of 2005 PhRMA "Special 301" Submission to United States Trade
Representative).  

·         Write to the government of India to ask for more information on the
issue and also to convey your concern on its possible decision on amending
the Drugs and Cosmetic Act to include such provisions.

·         Brief the parliamentarians and policy makers on the implications of data exclusivity

Mobilise public opinion against such move

Data exclusivity committee seeks more time to handle pharma issues

Monday, June 05, 2006 08:00 IST 
Joe C. Mathew, New Delhi

The high level committee constituted by the Central Government to examine the need for providing data protection in the context of the provisions of Article 39.3 of the TRIPS Agreement has once again deferred its decision on data protection in pharmaceutical sector. 

The inter-ministerial meeting that was expected to give a final view on the issue last week ended up calling for more debate among various stake holders before a consensus decision can be taken. The recent meeting of the committee held here decided to ask the Department of Industrial Policy and Promotion and Department of Health to re-examine their views on the issue and come up with their suggestions within two weeks. The final recommendations of the committee is thus to be delayed. 

According to the official sources, the committee has proposed a model that calls for a fix term data protection along with clauses of non-reliance of data for regulatory approvals during the period. The departments will have two weeks time to comment on the suggestion made by the committee. Industry views would also be sought, it is learnt. The decision of the data protection committee is to trigger intense lobbying by interest groups in the coming days. 

As of now, majority of the members are supporting a view to provide protection against disclosure of data and fixed term data exclusivity. 
The Department of Scientific and Industrial Research (DSIR) has made it clear that they are recommending three years data exclusivity along with sufficient safeguards. The major reason for toeing this line is the increasing US pressure to introduce sufficient data exclusivity provisions before India can think of expanding its trade relations with that country. The committee is also of the opinion that the introduction of some data exclusivity provisions would induce USA and other countries to introduce less stringent TRIPS plus measures in the future free trade agreements with those countries. 

As pharmabiz had reported, the inter-ministerial meeting was convened after the Prime Minister's Office (PMO) took serious note of the inability of the high level committee to finalize its observations even after two years. The PMO has asked the Chemicals Ministry, which set up the committee, to finalise the report at the earliest. In its response to the PMO, the Department of Chemicals and Petrochemicals informed that while the committee had reached at a consensus with regard to data exclusivity in agro-chemical sector, it needs more time to finalise its recommendations on pharma sector.
-------------- next part --------------
An HTML attachment was scrubbed...
URL: http://mail.sarai.net/pipermail/commons-law/attachments/20060608/712f1ea8/attachment.html