In a move that could significantly increase access to treatment for children affected by HIV, the Geneva-based Medicines Patent Pool (MPP) and ViiV Healthcare, a joint venture between pharmaceutical giants Pfizer and GSK, have announced a patent licence agreement for Abacavir — an important drug for treating children infected with the HIV virus.
ViiV Healthcare also announced plans to licence another paediatric HIV drug currently in the pipeline — dolutegravi — on similar terms, once regulatory approval is received to bring it into the market.
The move is expected to significantly reduce the cost of treatment by allowing generic manufacturers to make copycat versions of the two drugs without incurring sanctions for patent violations.
The Medicines Patent Pool, established in 2010 under the aegis of the World Health Organisation and UNITAID, works to lower the price of medicines for HIV and Aids, tuberculosis and malaria through an innovative mechanism that encourages brand holders to allow access to their patents by others under a patent pool.
A patent pool is a system through which the holder of a patent voluntarily surrenders the patent to a central organisation that then allows other companies and researchers to access the patent and develop comparable medicines.
While a small royalty may be paid, the beneficiaries are spared the cost of investing significant amounts in research by piggybacking on the research already done. This enables generic manufacturers to sell their medicines at much lower prices and without the risk of legal sanctions for violating patent rights.
The move by ViiV Healthcare was welcomed by health activists around the world particularly because of the limited range of paediatric formulations for treating children infected with HIV. In most cases, such children have to crush adult anti-retrovirals into smaller doses, which is cumbersome and ill-suited for children. It amounts to treatment through guesswork on dosage.
The abacavir licence covers 118 countries that collectively account for 98.7 per cent of HIV positive children in need of treatment. The licence makes no demands for royalty payments by beneficiary researchers and generic manufacturers.
It also does not designate countries where the drug is manufactured, is non-discriminatory on manufacturers and allows the product to be used in new fixed dose combinations or formulations, which is considered more effective in ensuring adherence to treatment.
An estimated 6,000 people die daily from Aids-related illnesses because of inability to access treatment. The high cost of newer anti-HIV drugs that are recommended by the World Health Organisation (WHO) is a key barrier to treatment. The 20-year patent monopoly for new drugs is blamed for locking out competition from generic manufacturers and hence maintaining high prices.
Generic manufactures can only manufacture copycat versions of older anti-HIV drugs that are off-patent while newer, more effective medicines, remain out of reach. Generic competition is credited with having lowered the cost of HIV treatment from an astronomical $10,000 per patient per year — when the treatments were first available ± to as low as $87.
This has increased the number of people on HIV treatment to over three million — the vast majority drawn from sub-Saharan Africa with Southern Africa bearing the biggest burden.
While there are over two million children living with HIV, less than 10 per cent have access to treatment primarily because of a lack of paediatric formulations and the unsuitability of adult versions.
The limited research on suitable paediatric formulations is blamed on the limited incentive to invest since 90 per cent of children living with HIV live in sub-Saharan Africa — the world’s poorest region. These children do not represent a commercially viable market to motivate research investment from pharmaceutical manufacturers.
Last year, another pharmaceutical manufacturer — Gilead — licensed its Aids drug, tenofovir. However, though the Gilead licence covered more products for both paediatric and adult HIV medication, it was criticised for excluding many developing and middle-income countries including Algeria, Egypt, Libya, Morocco, Philippines and Tunisia.
Health activists have raised similar concerns over the abacavir licence, which has excluded middle-income countries such as Brazil, China, Mexico, Peru, Venezuela, Uruguay, Ukraine and Russia, which have an estimated 47,000 children living with HIV. There is also concern that the adult formulation of the same drug is not included in the licence agreement and will be off-patent only after 2018 in many countries.
The recent ViiV license is viewed as having given the MPP fresh impetus in expanding access to generic versions of medicines for HIV/Aids. It affirms the need for innovative solutions in improving access to treatment in developing countries.
The licence is expected to place additional pressure on other pharmaceutical companies such as Johnson and Johnson, Abbott that have refused to license products to the patent pool, to reconsider their position.
Gichinga Ndirangu is regional co-ordinator for Health Action International Africa