Healthy Skepticism Library item: 17386

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Publication type: news

Boseley S
Time for drug giants to jump into the patent pool?
The Guardian 2010 Mar 10
http://www.guardian.co.uk/society/sarah-boseley-global-health

Full text:

While drugmaking giant GlaxoSmithKline has picked up a load of good press
for CEO Andrew Witty’s developing world initiatives – from ploughing back
some of the (tiny) profits made in Africa to the more interesting patent
pool it announced for neglected tropical diseases – it is Californian rival
Gilead that gets a higher approval rating at the moment from Aids
campaigners. Gilead has at least nominally embraced the idea of a patent
pool for HIV drugs, which the donor organisation UNITAID is currently
attempting to set up. GSK says it is interested in the concept and happy to
talk, but the language is just a tad more reserved.

For those who have not been immersed in the jargon of the HIV drug struggle
over the past few years, incidentally, a patent pool is a virtual concept,
involving patent-holding drug companies allowing anybody (in practice,
generic drugmakers in countries like India) to make cheap copies of their
drugs or – importantly – combine the drugs of several different big R&D
companies in a single pill for adults or children.

John Martin, CEO of Gilead, was in London yesterday and kindly invited me to
lunch at a hotel in Threadneedle Street, in the very heart of the banking
world, along with Paul Carter, senior vice president, international
commercial operations. Asked if he felt the need to reach out to the
developing world because of the appalling press that pharma has had in the
past, Martin shrugged. Gilead, which got its first HIV drug aproved in 2001,
pretty much post-dates the big scandals – the court case ten years ago in
South Africa by a coalition of drug companies which tried to stop the
government buying cheaper drugs from other countries and the initial
foot-dragging over slashing their prices for Aids drugs.

So Martin, who is clearly passionate about inventing and acquiring new HIV
drugs (Gilead overtook GSK in HIV a couple of years ago), appears to take it
as read that the company will help Africans access his medicines. Beyond its
not-for-profit scheme on drug sales in the poorest countries, Gilead has
licensed its “crown jewel”, tenofovir, to 13 generic companies -Aspen in
South Africa and the others in India – which can make it at a lower price
still.

He doesn’t have a problem with the HIV patent pool as long as we’re talking
about the poorest countries. There is an issue, however, with middle-income
countries. Gilead will not be so warm if UNITAID puts together a patent pool
that involves India or Brazil, countries in which it is currently fighting
for recognition of its patents. The no-profit policy in the poorest
countries “requires respect for patents” in richer ones, said Martin. Gilead
recognises four categories of wealth and therefore need – after the poorest
where they will not make profit, there are those countries like India where
they want to make a small profit, those where they expect to make a moderate
profit such as Brazil and finally those where they expect to make lots of
money, such as the UK and the USA.

I suspect the haggling around the patent pool will not be dissimilar to that
around TRIPS – the World Trade Organisation agreement that was supposed to
allow the manufacture of cheap copies of patented drugs, the complex
provisions of which have hardly ever been used.

Martin highlighted an issue that Medecins Sans Frontieres have been warning
about. New guidelines from the World Heallth Organisation say people with
HIV should be put on treatment much earlier than now (when their CD4 count – a measure of the capacity of the immune system to fight the virus) reaches
350 instead of the current 200. That’s going to mean we need a lot more
drugs for a lot more people. So talk of 10 million in need (of the 33
million infected, 4 million of whom are on treatment) is already out of
date. And secondly, the WHO also says we should no longer be using stavudine
(d4t), one of the cheapest Aids drugs there is, because of its painful and
debilitating side-effects. Hardly anybody is on it now in the west. Yet 2.3
million out of the 4 million on Aids drugs in poor countries are still
taking it.

Gilead’s tenofovir, sold as Viread, is one of the drugs they could take
instead, but it’s more expensive than stavudine. And Gilead has another drug
that could be incredibly helpful (all over the world) – the first once a day
three-drug combination pill. At the moment Africans must take two a day. But
Atripla, as it is called, is not completely safe in pregnancy – and vast
numbers of women of childbearing age have HIV in Africa.

So there is clearly a need to mix and match to get the drugs that
sub-Saharan Africa needs. The UNITAID patent pool looks ever more important.
Let’s hope it doesn’t get bogged down in years of legal wrangling over what
a country in need looks like.