Patents and intellectual property restrictions continue to affect access to antiretroviral drugs, particularly in middle-income settings, according to research presented at the 19th International AIDS Conference (AIDS 2012) in Washington DC on July 25.
generic competition has been essential to reducing the price of first-line
ARVs, because of patent protection, the price of second- and third-line drugs
have not seen a comparable drop. Presenting on a UNITAID-funded study on ARV
price determinants, Jean-Paul Moatti said: "When activists say there is
still a major problem for second- and third-line drugs, they are right.”
Globally, first-line drugs are 65.3% cheaper than second-line drugs.
of branded second-line drugs has actually been increasing since 2008/2009, says
Moatti, part of a general trend among pharmaceutical companies to increase the
price of their product at the end of a patent life. While there is an average
dip in price a few years into the 20-year period
– due primarily to pressure from
– the price actually increases before the drug goes off
patent, and increases even more after the patent has expired.
patent is over, branded drugs don't try to follow the generic companies and
engage in competition," said Moatti. Instead, in both developing and
developed world markets, "they try to differentiate their product with
packaging and so on”, keeping the price high.
the interim executive director of the Medicines Patents Pool, presented an
analysis of current trends in voluntary licensing practices globally. Park
noted that engaging in voluntary licenses was "hugely common throughout
the industry", with seven of the eight originator ARV companies signing
such agreements. Yet, "there's very little known about the various
provisions that can be included in these licenses….there is wide variance
within the industry,” he said.
access to medicine, Park is specifically concerned about the number of licensed
generic companies included in each agreement, and whether licensees can produce
their own active pharmaceutical ingredients (APIs), and/or purchase APIs from
other generic suppliers.
the number of licensees may hinder the robust generic competition that can
bring prices down,” Park said. “As a general rule, the more competitors there
are, the lower the price of the ARV." Given that the cost of APIs comprise
a "significant proportion" of a final generic production cost,
"there ought to be minimal restrictions on manufacture and sale of APIs by
on the methodology of the study, Chan noted that "a full evaluation of the
terms and conditions was impossible as a result of the absence of transparency
in voluntary licensing practice", as the full terms of voluntary licence
agreements are rarely made public. "Today, I call for increased
transparency in voluntary licensing practices, and for companies to adopt
access-maximising terms and conditions."
noted that while low-income countries are generally "well covered" in
the scope of voluntary licences, "we still have a long way to go with covering
on the panel, Kajal Bhardwaj of the Lawyers Collective noted that this was part
of a trend by pharmaceutical companies to increasingly "cut out”
middle-income countries from so-called “access policies”, in which
pharmaceutical companies engage in voluntary licences and/or differential
pricing, where lower-income and/or high burden countries pay less than their
richer counterparts. This is despite the fact that, according to the Human
Development Index, "more than half of the world's poor actually live in
middle-income countries," said Bhardwaj, with huge economic discrepancies
in places like India and South Africa.
result of the exclusion, Bhardwaj explained, middle-income countries have to
"negotiate separately on a case-by-case basis with these companies, which
makes it harder for them to get lower prices."
middle-income countries could utilise TRIPS flexibilities, specifically
compulsory licences, many do not have the legislative framework to do so, and
are being pressured by the world's superpowers to ramp up intellectual property
– The Agreement on Trade-Related Aspects of Intellectual Property Rights
– gives pharmaceutical companies the legal right to patent their drugs and applies to all the member states of the World Trade Organization.)
happening with the global aid and the global trade structure and how that
shapes our countries' decisions going forward should not be under-estimated,"
said Bhardwaj. "The reality is that we're actually going back on ten years
of progress. The minute you have exclusions, you will be leaving many, many
people out of treatment and access."
countries can flex their muscles. Francisco Viegas Neves da Silva of the
Brazilian Ministry of Health spoke on the country's compulsory licence for
efavirenz. Initially granted in 2007 for a period of five-years, and recently
renewed for another five, da Silva noted that the compulsory license
allowed for local generic production of the drug while still under patent
significantly brought down the price of a 200mg tablet from $2544 per patient
per year to $259 per patient per year (the current price is even lower at $107
per patient per year). Between 2007 and 2011 Brazil achieved savings of 58% in
efavirenz drug costs as a consequence of compulsory licensing, da Silva
access is more important than economics,” said da Silva. “This is about how we
can save money to put more patients on treatment."
said that Brazil's president, Dilma Roussef, would consider compulsory licences
for more antiretrovirals and other drugs, such as for non-communicable
diseases. He noted that simply having the threat of utilising a compulsory licence
is an important tool in negotiations with pharmaceutical companies.
according to Brazilian activists, the country can do more to promote access to
medicines. Pedro Villardi of the Brazilian Interdisciplinary AIDS Association,
or ABIA, presented the outcomes of a survey done by the Working Group on
Intellectual Property to consider whether and how pharmaceutical patents were
blocking access to medicine.
conducting a thorough patent search on ARVs, the group found multiple patents
on a single medicine, which could block access to generic versions. For
example, while the patent for darunavir is meant to expire in 2017, a new
patent filed could extend the patent to 2025. Villardi also noted that eleven
drugs included in the survey were only supplied by one producer; lack of
competition was keeping prices high.
said that increased transparency was essential. “The patent system is extremely
non-transparent and patents are supposed to be public,” he said. “If you don't
know [about] the patent and the patent application…you can design neither
public policies nor advocacy strategies to increase access to medicines, not
just in Brazil, but in all of the global south."
that the country utilise the Bolar, or early working, provision; implement
stricter patentability standards; and strengthen pre- and post-grant opposition