The Global Campaign for Microbicides (GCM) – along with others
players in the field of microbicide research and development – is
dedicated not only to accelerating microbicide product development
but also to facilitating the widespread access and use of these
products, once they become available.
Currently, microbicide researchers and advocates are collaborating
with regulatory authorities in some countries to determine what
regulatory requirements a microbicide will have to meet to be
approved for public distribution. These regulatory bodies are
responsible for ensuring that medicines and products are safe,
effective, high quality, and manufactured and stored appropriately;
that health professionals and individuals have appropriate
information; and that promotion and advertising is fair and
balanced. The World Health Organization has convened a series of
regional workshops in Africa and Asia to help educate national
regulatory authorities about microbicide science, product
development and clinical trials. Countries with strong national
regulatory authorities like South Africa and India may be able to
develop regulatory guidance that will be helpful to other countries
with less capacity in the area of evaluating new products.
While all these efforts are ongoing, it is important for all of us
to make sure that public expectations are not raised to unrealistic
levels. The first Microbicides will only be moderately effective and
even these first products may still be several years away from being
approved for use anywhere. The first microbicide will not be
launched in every country simultaneously, or even nationwide in
those countries that are first adopters (most likely countries in
southern Africa).
When, where, how and to whom new drugs become available depends on a number of factors, including the adequacy of the health infrastructure in a country; the political will within the
government and the willingness of the population generally to demand access to the new drugs. NHVMAG is one of the many partner and ally organizations that GCM is working with – in many countries — on efforts to educate governmental officials and build the public awareness required to make an effective demand on decision-makers to start planning now for how microbicide roll-out will occur and how it will be funded when the first successful products become available.
Scaling up manufacturing capacity to produce a large volume of
microbicides is also critical to ensuring access. It can take 18
months to three years to scale up manufacturing capacity
sufficiently to produce enough of a product for commercial
distribution. So it is important that this process begins early,
possibly even before the clinical trial of the candidate microbicide
is complete because if scale-up doesn’t happen, there is a risk of
delaying availability of an effective product. Product developers
and others in the field have begun to develop specific plans to
accelerate access by identifying manufacturers and planning for
manufacturing scale-up now.
Cost, of course, is also a key factor. At least one candidate
microbicide has already been stopped from going into human testing
because it was both too difficult and too expensive to produce. The
researchers decided that it didn’t matter whether the product worked
or not because it would be too expensive to be made widely available in poorer parts of the world. So they abandoned work on it.
Even products that are cheap to produce may still not be affordable
to many people who need them. For this reason, work is underway to
develop mechanisms to enable donors and/or governments to subsidize both product purchase and the programs required to deliver them.
Microbicides will be delivered through some mix of public, private,
and social marketing systems. This means that significant
investment also has to be made in strengthening commodity systems for delivering other public health goods, and that the microbicides field will be building on these efforts.
We all know that, historically, most new drugs are introduced first
in developed countries where people and health systems can afford to pay for them. It can often take a decade or more for products
to “trickle down” to developing country markets, and many new drugs and other health innovations never reach people in developing
countries. But advocates and researcher are determined that access to microbicides will follow a different pattern and we have a good
reasons to believe that this is possible. The reason is that
microbicides, unlike most drugs and prevention products, are not
being developed by pharmaceutical companies. The pharmaceutical
companies are driven primarily by the need to make profits. But
most of the organizations working to develop microbicides are not-
for-profit or academic institutions, and are supported by
philanthropic or government funding. So they can afford to be
concerned more with the public health goal of preventing HIV
infection, rather than profit.
The microbicide field, therefore, is primarily focused on ensuring
access to microbicides at an affordable price. Several donor and
product developer require in their contracts that a product can be
made available at low cost in resource poor settings. Microbicide
advocates have already started working with regulators,
manufacturers, governments, health care providers, donors and other civil society actors to do what needs to be done to make sure that people who want to use microbicides – especially those at highest risk of HIV infection — are able to get them consistently, at a convenient place, at an affordable price, and use them in their
daily lives.
Anna Forbes
Deputy Director
Global Campaign for Microbicides
1800 K Street NW, Suite 800
Washington DC , 20006
USA
