[Ip-health] Data exclusivity a life and death issue
jockey.kit at gmail.com
Tue Aug 21 23:27:56 PDT 2012
During the last week of July, a team from the Department of Trade
Negotiation (DTN) went to Brussels to work on a scoping exercise with the
European Union Trade Commission. On their return to Bangkok a meeting was
called by Deputy Prime Minister Kittiratt Na-Ranong at which officers from
various government departments were present including, the DTN, the Food
and Drug Administration, the Department of Intellectual Property, the Bank
of Thailand and the Commerce, and Agriculture and Cooperatives ministries
The meeting had been called in order to move forward the Thai-EU Free Trade
Agreement (FTA) and the DTN, as secretariat of the meeting, reported back
on the discussions they had with the commission in Brussels.
According to a leaked position paper of the DTN five sensitive issues were
discussed; alcohol and tobacco, intellectual property rights, government
procurement, competition and services. The document goes on to suggests
that the Thai government take a flexible position on intellectual property
rights during any negotiations with the EU by accepting the trade-related
aspects of intellectual property rights (Trips) agreement plus provisions,
although they recognise this topic is highly controversial among civil
In particular the DTN argue that five years of data exclusivity should be
accepted as it would have no impact on the current price of medicine and
that although data exclusivity might delay generic medicine's entry into
the market by five years this would have very limited impact on overall
access to medicines.
At the end of the meeting Mr Kittiratt said that negotiations with the EU
should start as soon as possible; that there is no need to hold further
public hearings and therefore the government will submit the draft
framework of negotiation to parliament within the month.
This headlong rush into opening negotiations with the EU and the apparent
willingness of the negotiators to offer to accept data exclusivity is
extremely worrying to civil society groups and organisations who have seen
the negative consequences on public health of such agreements.
We would therefore like to state clearly that data exclusivity is not
currently required in international law. The Trips agreement requires
member states to protect clinical data, but there is no obligation to grant
any period of monopoly or exclusivity in the use of these data.
When a generic manufacturer applies to register and sell a generic version
of a previously-registered medicine, the manufacturer has to provide data
showing that their product is bioequivalent to the original registration.
The drug regulatory agency already has the necessary clinical data for
safety and efficacy, submitted by the originator, and must only assess if
the generic version meets bioequivalence standards.
The introduction of data exclusivity prevents drug regulatory agencies from
referring to existing clinical data to approve registration of generic
versions of a drug by "locking up" the clinical data for a period of years,
shutting down the entry of price-lowering generic competition for the
duration of the exclusivity.
Data exclusivity essentially creates a new system for granting monopolies
in order to prevent generic competition.
Generic manufacturers are forced to wait for the "data monopoly" period to
end, even if the drug is unpatented, and even when a compulsory license is
issued to override the patent.
The only way a generic manufacturer can get a drug registered without
access to existing clinical data is to repeat the clinical trials. However,
duplicating clinical trials is not only extremely costly, but also
unethical, since safety and efficacy has technically already been
established, rendering further clinical trials medically unnecessary.
Many experts and UN agencies, including the World Health Organisation,
United Nations Development Programme and UNAids, have recommended
developing countries do not incorporate data exclusivity in their national
Data exclusivity can delay the registration of generic or biosimilar
versions of a medicine for many years. Some of the newest breakthrough
medicines are biologics sold at extremely high prices. The introduction of
data exclusivity for biologics will delay the introduction of affordable
versions of these medications. The need for low-cost biosimilar
alternatives to highly expensive lifesaving drugs, including Pegylated
Interferon to treat Hepatitis C and Herceptin to treat breast cancer, is
Data exclusivity, when implemented in national law, provides a distinct
monopoly from patent rights that often results in high prices and a delay
in market entry of generics.
As a part of the United States-Jordan FTA, Jordan implemented data
exclusivity. A study conducted by Oxfam in 2007 found that of 103 medicines
registered and launched since 2001 that had no patent protection in Jordan,
at least 79% had no competition from a generic equivalent as a consequence
of data exclusivity. The study also found that prices of these medicines
under data exclusivity were up to 800% higher than in neighbouring Egypt.
A 2010 study by the Centre for Policy Analysis on Trade and Health
determined that once Guatemala enacted data exclusivity, some medicine
prices rose as much as 846% _ even though just a handful of medicines were
under patent protection.
Data exclusivity a life and death issue
Data exclusivity raises the price of medicines even when no patent exists.
For example, in the US, the price of colchicine, a treatment used mainly
for gout, rose more than 5,000% after data exclusivity was enacted.
Colchicine has been in use for thousands of years, costs almost nothing to
produce, and cannot be patented. Therefore, generic formulations of the
tablet have been widely available since the 19th century. However, a new
monopoly on colchicine was created in 2009 when the US Food and Drugs
Administration accepted clinical data from a one-week trial of the drug and
granted data exclusivity to URL Pharma. URL Pharma subsequently sued to
force other manufacturers off the market, and raised prices from US$0.09 to
$4.85 per pill.
We would therefore take this opportunity to request that the Thai
government take a firm position of refusing any Trips plus demands in all
forthcoming negotiations with the European Union that would adversely
affect the cost and consequent access to medicines and medical technologies.
*Paul Cawthorne is an officer on the Access to Essential Medicines
Campaign, Medecins Sans Frontieres.*
More information about the Ip-health