[Ip-health] News: IPS News- "Anti-Counterfeit Deal Threatens Accessibility of Drugs"

Terri - Louise Beswick Terri at haiweb.org
Mon Jun 28 08:24:29 PDT 2010

"Anti-Counterfeit Deal Threatens Accessibility of Drugs"

By Adam Robert Green


Credit:Eva-Lotta Jansson/Oxfam


LONDON, Jun 28, 2010 (IPS) - A proposed anti-counterfeit trade deal
between 10 countries and the European Union (EU) could create "a new set
of barriers to the export of generic medicines to low income countries".


This warning comes from Rohit Malpani, senior advisor at Oxfam America,
who spoke to IPS on the eve of the ninth round of negotiations on the
Anti-Counterfeiting Trade Agreement (ACTA) taking place from Jun 28 to
Jul 1 in Lucerne, Switzerland.


ACTA is aimed at tackling the trade in fake products -- from luxury
watches and cosmetics to car parts and medicine - and those persons
infringing on intellectual property (IP) rights by strengthening powers
of customs officials in signatory countries to seize counterfeit goods.


International trade of IP-infringing products is worth over 150 billion
euro per year, according to estimates of the Organisation for Economic
Cooperation and Development (OECD), representing rich countries.


Instigated by the U.S. and Japan in 2006, the ACTA negotiators now
include the EU, Australia, Canada, Korea, Mexico, Morocco, New Zealand,
Singapore and Switzerland.


But, critics warn, by not clearly distinguishing between fake medicines
and legal generic drugs, which are often subject to patent dispute, the
agreement could lead to the wrongful seizure of generic medicines en
route to developing countries.


"ACTA is not just focusing on issues related to trademark law - that is,
medicines that are illegally and deceptively mislabelled - but will also
include patent law, which means that generic drugs will be covered,"
explains Joel Lexchin, MD, professor in the school of health policy and
management at York University, Canada.


A patent involves the exclusive right, granted by a government, to use
an invention for a specific period of time.


According to Lexchin, ACTA's inclusion of patents "could substantially
impede the flow of generic medicines. For instance, a company could
claim that its IP rights have been violated in the production of a
generic drug." That drug could then be seized by customs officials when
it enters the country.


According to the World Trade Organisation's (WTO's) Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPs), WTO
members must grant exclusive patent rights on medicines.


However, they can in some circumstances allow the production of
lower-cost, generic versions of patented drugs in exchange for royalties
paid to the patent holder.


But, crucially, TRIPs only allows such medicines to be sold in the
domestic market of the developing country that produces it. Problems
thus arise when low income countries, which cannot make their own
generics, import them from larger developing countries like India, and
in transit they enter a country where the patent is active.


"Under ACTA, a multinational pharmaceutical company can say to customs
officials in the transit country: 'That product infringes our patent in
this territory, so even though the medicine is safe and can be legally
exported from one developing country to another, we still want you to
prevent it from reaching its destination','" Malpani explains.


Such seizures occurred after the European Commission (EC) issued a
crackdown on IP infringement which led to shipments of generic drugs
being wrongfully intercepted.


Companies from India - dubbed the "pharmacy of the developing world" for
its leading generics sector - had HIV, cardiovascular disease and common
infections drugs, on their way to African countries, turned back by
overzealous EU customs officials.


A famous case concerns the antiretroviral medicine, abacavir, shipped
from India with Nigeria as destination but intercepted in the
Netherlands. GlaxoSmithKline, the patent-holder, did not wish to
initiate a legal action but Dutch customs authorities still referred the
case to the criminal courts.


Felix Addor, deputy director general of the Swiss Federal Institute of
Intellectual Property, told IPS that such outcomes mean the broad
approach is unworkable.


"Initially we did not see how you could discriminate between different
IP rights. But having analysed the various transit cases, we now
advocate that ACTA should either exclude patent-protected goods entirely
or at least exclude these products from any border measures.


"We expect that this decision will ultimately be supported by other


Swiss pharmaceutical companies deny civil society accusations that the
industry wants to use ACTA to crack down on competing generics.


"It is neither the policy nor the practice of our member companies to
encourage authorities to use IP law enforcement to prevent the flow of
legitimate generic products," says Bruno Henggi, head of public affairs
at Interpharma, which represents major Swiss multinationals including
Novartis and Roche.


"We advocate that ACTA excludes patents from its scope. Our companies
contribute to improving access to medicines in developing countries via
large-scale donation programmes, preferential pricing and voluntary
licensing, as well as through extensive participation in not-for-profit
partnership activities."


If ACTA includes patent-protected generics and more developing countries
sign up to the agreement, generics will be obstructed. This will cause
"competition to be delayed, (hence) medicine prices will increase,"
Malpani predicts.


"Ultimately, high prices for medicines encourage counterfeiters to sell
those very fake medicines that ACTA is trying to stamp out."


The justification that ACTA will tackle fake medicines, which account
for almost 10 percent of world medicine, is widely rejected. Wilfully
mislabelled medicines are already illegal under TRIPS, and patent
infringement "has nothing to do with fake or dangerous medicines",
Malpani argues.


Lexchin adds that, "the public health problem related to counterfeits is
that substandard medicines will be used or medicines will contain
contaminated or substituted ingredients."


The way to address this, though, "is through better regulation of the
pharmaceutical supply chain from producer to end user, particularly by
strengthening regulatory authorities in developing countries". (END)



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