[Ip-health] Europe attacking access to affordable generic drugs

Kar K. kakablueblue at gmail.com
Wed Nov 24 04:40:22 PST 2010

 Europe attacking access to affordable generic drugs

   - Published: 24/11/2010 at 12:00 AM
   - Newspaper section:

    Millions of people in developing countries rely on affordable quality
generic medicines produced in India to stay alive. In fact, Medecins Sans
Frontires (MSF) sources more than 80% of the HIV medicines it uses to treat
160,000 patients across the world from India, and a recent study found that
from 2003-2008, more than 80% of donor-funded purchases of HIV medicines
came from India.

Children with Aids (above) are looked after at the child care centre in
Phnom Penh. Below is a poster distributed by the Vineeta Foundation. Today’s
innocent children born with Aids will also be affected by the difficulties
associated with accessing vital treatment.

Manufacturers in India have been able to produce cheaper versions of drugs
patented elsewhere because until 2005, the country did not grant patents on
medicines and multiple producers competed for the market, driving prices for
the most-affordable drug combination down by more than 99% over the last

Since 2005, however, patents have been granted on medicines in India, in
particular on newer drugs, as ones developed before 1995 do not deserve a
patent under India's pro-public health patent law. The future of access to
newer medicines, urgently needed for the treatment of HIV/Aids, is therefore
already in question.

Now the European Union is dealing another blow by pushing trade policies
upon India through a free trade agreement (FTA) and through the
Anti-Counterfeiting Trade Agreement (ACTA) that will both severely restrict
the ability of India to remain the key source of affordable medicines in the

There is a constant refrain from rich governments, pharmaceutical giants and
the business press that developing countries' intellectual property laws
need to change and are unfriendly to business interests. What is talked less
about is the consequence of the changes proposed.

Currently, the EU is negotiating an FTA with India in which they are
demanding a number of provisions that extend big pharma's protection from
competitors and undermine the careful balance that India has created in its
patent and drug registration laws.

One such provision _ the effects of which are little understood _ is the
EU's demand that India introduce a new protection for multinational
pharmaceutical companies from normal price competition. It is called "data

Data exclusivity would prevent the Indian drug regulatory authority from
granting marketing approval for generic medicines for a period of time that
could be up 10 years.

Currently, when a generic manufacturer applies to register another version
of an already-registered medicine, they only have to demonstrate that their
product is therapeutically equivalent to the original. To fulfil the
efficacy and safety requirements, the drug regulatory authority relies on
the registration file of the original manufacturer.

But data exclusivity prevents this, by allowing the originator company to
keep its registration data private. In practical terms, data exclusivity
prevents the registration of generic versions of a medicine for a set period
of time, unless the generic manufacturer were to repeat the drug trials that
the originator has done, even though such repeat tests are unethical and

The EU claims data exclusivity is required under international law. It is
not. It also claims that there will be no harm to access to medicines. But
other countries have learned the hard way how harmful it can be.

The EU further claims that any harm will be limited because data exclusivity
will be lifted if a compulsory licence is issued. But what they do not say
is that data exclusivity will apply even when a medicine would not deserve a
patent under India's strict patent law that prevents companies from getting
patents for making minor changes to medicines that have no added therapeutic

A second threat to generic medicines that is being aggressively pursued by
the EU is ACTA, which has been negotiated in secret. The idea is that once
signed, ACTA will be extended to developing countries. One of the
justifications for the treaty is that it is needed to fight against the
trade in counterfeit medicines. This was the same justification given for
the World Trade Organisation's TRIPS agreement which developing countries
have already agreed to.

But unlike TRIPS, ACTA does not contain protections against abuse by
companies and indeed encourages overzealous enforcement.

In a windfall to big pharma, ACTA will use public money to enforce private
rights. It widens the enforcement net so that legitimate medicines could be
detained in transit or destroyed simply because their label looked similar
to the originator product (commercial trademark infringement). This has
nothing to do with protecting the public from fake medicines, and limits the
courts' ability to balance public health and profits.

On a mere allegation and not proof, including by a competitor, generic
suppliers allegedly infringing a patent or a trademark may face the delay or
destruction of goods, disproportionate damages, potential bankruptcy, and in
some cases, even criminal proceedings.

And by extending liability to third parties, ACTA puts suppliers of active
pharmaceutical ingredients used for producing generic medicines;
distributors and retailers who stock generic medicines; non-governmental
organisations such as MSF who provide treatment; funders who support health
programmes; and drug regulatory authorities who examine medicines, at risk
of injunctions, provisional measures, and even criminal penalties, including
imprisonment and severe economic losses.

This could act as a significant deterrent to anyone involved in the
production, sale or distribution of affordable generic medicines.

Even the United States is opposing a number of the provisions that the EU
refuses to back down on, such as the inclusion of patents in the agreement
and the increasing of the scope beyond wilful trademark infringement.

The spectre of harmful fake medicines is one of the concerns used to justify
ACTA. Yet ACTA's real purpose is not designed to deal with fraudulent,
unsafe, and ineffective medicines; its purpose is to protect the commercial
interests of multi-national companies.

Action against unsafe medicines requires a global solution developed through
a legitimate process, in which all countries are involved. Developing
countries have asked that such discussions take place at the World Health
Organisation and other multilateral institutions rather than amongst a few
countries, behind closed doors.

The sad truth is that ACTA would inhibit generic competition and increase
drug prices, which actually incentivises the introduction of counterfeit
medicines _ WHO has recognised that high drug prices are a cause of
counterfeit medicines: patients demand low-cost alternatives, and
counterfeiters respond.The EU claims it wants to safeguard access to
medicines in developing countries. Unless the EU-India FTA and ACTA are
changed to remove the threat to such access, these are empty words.


Paul Cawthorne is an officer on the Access to Essential Medicines Campaign,
Medecins Sans Frontires.

Kannikar Kijtiwatchakul

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