Cheap HPV vaccines 'possible without violating patent laws'
[NEW DELHI] Developing countries could produce cheaper vaccines that protect against cervical cancer by using routes that do not violate patents on existing costly products, a review article suggests.
Low-cost vaccines could be crucial in the fight against cervical cancer, as they act against the sexually transmitted human papilloma virus (HPV), the primary risk factor for the disease. The WHO estimates that 500,000 new cases of cervical cancer occur each year, 80 per cent of which are in low-income countries.
The two vaccines currently available — from Merck and GlaxoSmithKline — cost up to US$300, far too costly for most developing countries.
But Subhashini Chandrasekharan, senior research associate at Duke University, United States, and colleagues, report that patents on these first-generation cervical cancer vaccines "do not seriously inhibit" the efforts of developing country vaccine manufacturers (DCVMs).
They say that the current vaccines do not protect against several cancer-causing strains of HPV that present in low-income countries, and suggest that DCVMs could make products that include antigens missing in the patented versions.
The review focused on India, which not only accounts for almost a quarter of the global cervical cancer burden but has also pioneered an inexpensive hepatitis B vaccine and generic versions of anti-HIV drugs.
This has become more difficult now that developing countries have signed the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement under the World Trade Organization, as the agreement requires the country to recognise patents for both the product and the process to make it.
The authors say that universities and not-for-profit organisations that develop new vaccine technologies should ensure they can be licensed by several manufacturers, rather than allowing one pharmaceutical firm to own the product after clinical trials.
"Much will depend on how licences are structured, or whether provisions are made for regional manufacturers to have the freedom to make cheaper versions," Chandrasekharan told SciDev.Net.
"It will also depend on whether institutions actively decide to transfer technology and know-how through collaborations or partnerships for vaccine development," she added.
Recently, a new type of technology transfer agreement between the US National Institutes of Health and an Indian vaccine company, Serum Institute of India, has helped produce a cheap meningitis vaccine for Africa.
Chandrasekharan pointed out that their review has not been easy "as more often than not there is very little transparency about licence agreements and it is even harder to identify what patents have been filed or granted in different developing countries because of a lack of resources for patent searching and analysis."
The review, published in Nature Biotechnology this month (July) follows a report released in May by international charities Médicins Sans Frontiers and Oxfam International that showed the poor are still missing out on key vaccines.
Nature Biotechnology 28, 671 (2010)