Source: Citizen
4 Sep 2014
In July, Ecuador issued four compulsory licenses for medicines
targeting cancer and arthritis treatment and immunological reception
to kidney transplant.1 These licenses authorize cost-cutting generic
competition with patented medicines, in exchange for royalty payments
to the patent holders. Compulsory licensing is a crucial tool to
expand access to medicines that are prohibitively expensive or whose
costs place enormous burdens on budgets for health systems.2 Ecuador
has again demonstrated international leadership by exercising its
health rights.
The same month, however, Ecuador also signed a trade agreement with
the European Union that may undermine access to medicines.3
Intellectual property was among several sensitive topics in the
negotiations. The text is not yet public, but Ecuador ultimately bowed
to EU pressure to adopt exclusivity measures which protect
pharmaceutical monopolies and keep prices high.
Notably, Ecuador’s public pharmaceutical firm ENFARMA withdrew several
additional compulsory license requests during the latter stages of
Ecuador’s negotiations with the EU. The timing of the withdrawals
raises a serious question as to whether this decision was influenced
by the negotiations. Ecuador’s pro-health policies continue to suffer
inappropriate challenges from commercial interests with influence in
the government.
Ecuador established ENFARMA in 2009 with the goal of improving the
well-being of Ecuadorian society through the manufacture and
distribution of safe and effective medicines at affordable prices, in
part through Ecuador’s licensing protocol.4 Ecuador announced the new
compulsory licenses at a press conference that included the Ministry
of Health, the Ecuadorian Institute for Intellectual Property (IEPI)
and the National Secretariat for Higher Education, Science, Technology
and Innovation (SENECYT).5
Ecuador’s licensing protocol conforms to World Trade Organization
(WTO) rules.6 The new EU-sponsored exclusivity measures go beyond the
data protection required by WTO rules.7 Health advocates should sound
the alarm. A study conducted by the Colombian foundation IFARMA
identified cancer and AIDS treatments as the types of medicines most
affected by data exclusivity.8
Ecuador should take steps to mitigate the harmful effects of the
exclusivity rules. For example, implementing regulations should
empower health agencies to exempt products from data or marketing
exclusivity (and thereby facilitate generic competition) in order to
protect health. More information about Ecuador’s access to medicines
policy is available at: www.citizen.org/actions-ecuador.
