Campaigners say Data Exclusivity and other terms included in the
proposed agreement could threaten the supply of affordable medicines
India currently provides to the developing world. With over 80%
of the HIV medicines currently keeping people living with HIV in
developing countries alive, they claim the FTA has the potential
to have a devastating impact on the health of the world’s
poor. This argument was recently supported by Hans Hogerzeil the
Director of Medicines Policy and Standards at the World Health Organisation.
Stop AIDS Campaign coordinator, Diarmaid McDonald
said:
“This EU attack on the health of poor people
in India and around the world is utterly unacceptable. It is a shameful
drive to edge up pharmaceutical profits at the expense of vulnerable
people across Africa and Asia. The UK has a strong tradition of
protecting the rights of these people and it is essential Vince
Cable continues this by demanding the EU stops pressing for Data
Exclusivity and other harmful provisions in this FTA.”
Data Exclusivity could lead to delays of up to
ten years in the availability of affordable generic drugs. India
has very carefully balanced the need to protect intellectual property
with the public health needs of its people, but Data Exclusivity
would undermine the very restrictions which ensure people’s
health comes before profit.
New drugs need to go through clinical trials to
prove their safety and efficacy. Currently generic manufacturers
can legally produce more affordable versions of drugs by proving
that their drug is chemically and biologically equivalent to the
original version. They do not have to repeat the trials that prove
that the medicines itself is safe and efficacious since the regulatory
authority approving the drug can see this from the results of the
original clinical trial. Data exclusivity would mean the trial data
would be exclusive to the company who ran the trial, and regulatory
authorities would have to ask the second company to repeat the same
trials to prove something that is already known. With the costs
of running trials prohibitively expensive this essentially acts
as another barrier to affordable new medicines for up to ten years.
Lotti Rutter of the Student Stop AIDS Campaign
said:
“India is known as the pharmacy of the world.
This FTA could damage the health of millions of people, delaying
the introduction of vital medicines at affordable prices. Data exclusivity
is also totally ethically unacceptable as it could force companies
to re-run clinical trials with real patients – risking the
health of the a control group – to prove something we already
know.
“It is essential the UK and Vince Cable
are vocal about their opposition to this in public and in the private
negotiations.”
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