The Medicines
Patent Pool and UNITAID today announce the first agreement between the
Medicines Patent Pool and a pharmaceutical company - Gilead Sciences - to
improve access to HIV and Hepatitis B treatment in developing countries.
The agreement
allows for the production of the HIV medicines tenofovir, emtricitabine,
cobicistat, and elvitegravir as well as a combination of these products in a
single pill known as the “Quad.” Cobicistat, elvitegravir and the Quad are
products still in clinical development. The licence also allows for the
development and manufacture of other combinations that include these medicines.
Tenofovir is also licenced for use in Hepatitis B.
“Today marks a
milestone in managing patents for public health. The licence agreement with
Gilead Sciences will help make medicines available at a lower-cost and in
easier to use formulations without delays,” said Ellen `t Hoen, executive
director of the Medicines Patent Pool. “In particular, the licensing of
elvitegravir, cobicistat and the Quad while they are still in clinical
development should significantly accelerate availability. People in developing
countries often have to wait for years before they can access new health
technologies. Today`s agreement changed that.”
“We believe the
Pool is an innovative mechanism to increase access to patented medicines in a
way that works for the pharmaceutical industry and people living with HIV,”
said Gregg Alton, Executive Vice President, Corporate and Medical Affairs for
Gilead Sciences. “We are pleased to enter into this collaboration, and we
hope to see the Pool become an effective mechanism for providing access to an
increasingly broader range of antiretrovirals to treat HIV in resource-limited
parts of the world.”
"UNITAID
has worked for four years to develop the Medicines Patent Pool concept.
Today we are proud to see that it is becoming a tangible reality," said
Philippe Douste-Blazy, chair of the UNITAID Executive Board. "I
salute this first important step by Gilead and urge other pharmaceutical companies
to place their intellectual property at the service of global public
health."
"The
United Kingdom has been a strong supporter of the Medicines Patent Pool from
day one. We welcome the news of their first pharmaceutical company
licence. We will continue to support the Pool as an important
contribution to ensuring that the largest number of people living with HIV get
access to the treatments they need," said Stephen O`Brien, Minister of
International Development for the UK.
Key features of
the licence include:
Inclusion of pipeline products
cobicistat, elvitegravir, and the Quad: Public health-oriented licensing
of products in clinical development is rare and is an important advance in
a field where many potentially valuable medicines are still in the
developmental phase. This licence will allow for generic versions of new
products to enter the market shortly after the products are available in
rich countries.
Preservation of key public health
safeguards in intellectual property: For example, the agreement preserves
the ability of generic companies to supply countries if governments issue
compulsory licences. It also waives data exclusivity rights where they
exist.
The Pool is committed to promoting
transparency in licensing practices and will publish the licences on its
website, welcoming feedback and suggested improvements from all
stakeholders.
The licence allows for the first
time the sale and use of generic tenofovir to cover the treatment of
people with Hepatitis B as well as HIV.
Royalties are 3 to 5 per cent of
generic sales, with royalties waived for any new paediatric formulations.
Expansion in the number of
countries included in the geographic scope as compared to Gilead`s earlier
licences. The licences will allow for the supply of tenofovir and
emtricitabine in 111 countries, for cobicistat in 102 countries, and for
elvitegravir and the Quad in 99 countries. However, the licences do
not include all developing countries.
“We will
continue to work with Gilead and others to expand access to all people living
with HIV in developing countries,” said `t Hoen. The Pool is currently in
negotiations with 6 other patent holders.
Keywords: Medicines / Patent Pool / Licences / HIV/AIDS