Diseases that disproportionately affect developing countries – such as
malaria and tuberculosis – place pharmaceutical companies in a dilemma.
To do nothing is to leave millions of people to die or suffer each year
when, in theory, the means may be out there to tackle the problem. Yet
the harsh reality is that people in the affected countries can rarely
afford to pay for drugs – and that even hugely profitable
multinationals can’t spend vast sums of money developing and
distributing cures for little or no return.
That’s why GlaxoSmithKline’s work on developing vaccines and medicines
through public-private partnerships looks so promising. Over the past
ten years, in conjunction with governments, foundations and NGOs, GSK
believes it has put together a working model that can overcome the
market barriers and, in the words of Jon Pender, the company’s director
of government affairs, ‘has transformed the pipeline of research and
development projects for diseases of the developing world’.
GSK is not the only pharmaceutical company to have gone down this
route, but it believes its extensive work on such partnerships means
it’s the only business in the world now researching new vaccines and
treatments for HIV/Aids, tuberculosis and malaria – the priority
diseases of the World Health Organization.
The path to partnerships began when GSK joined up some years ago with
WHO, the UK government’s Department for International Development, the
University of Liverpool, and the London School of Hygiene and Tropical
Medicine, to work on developing an anti-malarial drug therapy
christened Lapdap. The work was successful; it produced a treatment
that could help sufferers of a particular strain of malaria in
sub-Saharan Africa. But it also established a way of working that could
be carried over into other partnerships. Expenses for drug development
were divided between GSK, WHO and DfiD, each paying a third, while GSK
agreed to sell Lapdap at a not-for-profit price to the public sector
but could price it to make a profit when selling privately. GSK covered
the manpower and infrastructure expenses, but the contributions of
other partners meant that the company’s investment in Lapdap was low
enough to make the exercise financially viable.
Enthused by the success of that partnership, GSK has gone on to use the
experience in other areas, most notably with the Medicines for Malaria
Venture, which now manages 20 projects – the largest portfolio of
malaria drug research in history.
In this collaboration, as is often the case in its other partnerships,
the company provides the research and development plus manufacturing
and distribution expertise. Academic institutions help with research,
while public and voluntary sector partners such as the United States
Agency for International Development and the Rockefeller Foundation
help fund the development and delivery costs – and try to ensure that
medicines get to the people who need them.
GSK has also created a specialist ‘drug discovery centre’ based in Tres
Cantos in Spain, which focuses primarily on malaria and TB
and prioritizes research projects according to their social and public
health benefits rather than their commercial returns. It employs more
than 100 scientists, half subsidized by the company’s partner
organizations. Research is overseen by joint steering committees with
representatives from GSK and its partners.
As medicines move into clinical development, partners contribute to the
cost of running clinical trials and look at how to distribute the
drugs. This reduces the cost of development for GSK and gets new
products to patients faster. For instance, for one malaria product now
in clinical trials, Dacart, GSK pays the internal costs of the clinical
trials, such as providing the medicines for the trials and the staff to
establish and oversee them, while others in the partnership pay most of
the external costs, such as payments to the physicians and hospitals
conducting the research. These contributions make the project workable
for GSK and will enable the company to provide Dacart at a
not-for-profit price to public sector purchasers, initially in
sub-Saharan Africa.
A similar research and development group exists within GSK’s vaccines
business, working on development of vaccines for diseases predominantly
affecting the developing world. In partnership with the PATH Malaria
Vaccine Initiative, GSK is making good progress on a potential malaria
vaccine, with the hope that this will protect children living in
sub-Saharan Africa. Thanks to $21.4million support from the Bill &
Melinda Gates Foundation, GSK will be able to carry out clinical trials
in Africa – with the company more than matching the external
contribution it receives to defray some of the clinical development
costs.
And it’s not just malaria that partnerships can tackle. GSK has also
been involved in setting up the Global Alliance for TB Drug
Development, another PPP, which has created the first new advance in
developing an anti-tuberculosis drug since the 1960s. A separate
partnership between GSK and the specially formed Aeras Global TB
Vaccine Foundation, in which the Dutch Ministry of Foreign Affairs and
the Danish International Development Agency are involved, is also
making progress on developing a TB vaccine that has shown promising
results in early-stage clinical trials. And there is work being carried
out on an HIV/Aids vaccine through a partnership called the
International AIDS Vaccine Initiative, in which GSK works with the
Uganda Virus Research Institute and the Indian Council of Medical
Research, among others.
GSK’s vice president of corporate responsibility, Julia King, believes
the partnerships are a classic example of strength through unity. ‘They
require flexibility, transparency and trust, but they’re a model that
bring different skills and resources to a problem and enable us all to
do what we could not do alone,’ she says.
Apart from the obvious plus points for the potential users of the drugs
developed through these partnerships, GSK itself benefits. ‘Companies
that respond sensitively and with commitment by changing their business
practices to address such challenges will be the leaders of the
future,’ argues Pender.
There are, inevitably, some concerns. There is heavy reliance on
funding from private foundations, and GSK is urging developed world
governments to become more involved so that funding sources are more
diverse and therefore more secure. And partnerships have to be
carefully managed with ‘clear, shared objectives’ so that everyone is
singing from the same hymn sheet. It also takes time to build
confidence between partners with different perspectives. But as King
says, ‘this approach can work where neither pure philanthropy nor pure
commerce will work’. As a result, GSK expects to be involved in more
such ventures in the future.
