Technology Transfer & ARV Licensing in Developing Countries

Pharmaceutical companies' preferential pricing of antiretrovirals make effective, safe, high quality HIV/AIDS treatments available to developing countries. In some cases, companies also issue voluntary licenses (VLs) which allow local manufacturers in developing countries to produce and sell generic versions of their products. VLs are not a universal solution to HIV/AIDS but a response to specific circumstances. Local factors encouraging VL use include a severe HIV/AIDS epidemic, adequate health care infrastructure, suitable economic conditions and sufficient manufacturing expertise. Local manufacturers must ensure a long-term supply of good-quality medicines and implement safeguards to prevent diversion of medicines to wealthier markets.

Along with its policy to expand access to nevirapine in Least Developed Countries, low income countries and all countries in Africa, Boehringer Ingelheim offers a non-assert declaration to all WHO pre-qualified manufacturers, stating that it will not enforce its nevirapine patent rights in these countries, in order to ensure supply at lowest possible cost. To date, eleven generic producers benefit from the non-assert declaration. The policy reinforces the need to allow only high-quality products to be distributed in developing countries.

Since 2001, Bristol-Myers Squibb has had a policy of not enforcing its patents for HIV products in sub-Saharan Africa and has immunity from suit agreements with eleven African generic companies for stavudine and didanosine and three for atazanavir. In February 2006, it concluded technology transfer agreements with generic companies Aspen PharmaCare (South Africa) and Emcure Pharmaceuticals (India), for its newest antiretroviral, atazanavir (sold as Reyataz® in the US). Bristol-Myers Squibb has transferred intellectual property and technical know-how related to the manufacturing, testing, packaging, storage and handling of the active pharmaceutical ingredient and finished dosage form.

Gilead has partnered with Aspen Pharmacare, South Africa to manufacture and distribute branded and generic versions of Viread® and Truvada® in Africa. Gilead has entered into non-exclusive licensing agreements with 13 Indian generic companies, allowing them to distribute generic versions of tenofovir and tenofovir-based regimens in 95 developing countries, including India, South Africa and Thailand. The agreements include technology transfer to ensure high-quality products. The generic companies are free to establish their own pricing for their products, as Gilead believes this will ensure competitive pricing and the broadest access possible for patients. Gilead receives a five percent royalty on finished product sales. These Indian generic manufacturers have received a combined 10 tentative approvals through the U.S. Food and Drug Administration and two prequalifications by the World Health Organization. Most importantly, more than 700,000 patients are now receiving Gilead's medicines and more than half of these patients are receiving high-quality, low-cost generic versions of Gilead's medicines.

GlaxoSmithKline granted its first voluntary license in 2001. Now under the auspices of ViiV Healthcare, the number of licenses has been extended to eight royalty free licensing agreements for ViiV Healthcare's ARVs to all of sub-Saharan Africa. Since August 2007 ViiV Healthcare has allowed Apotex, a Canadian company, to manufacture a generic fixed-dose combination ARV, containing two molecules over which ViiV Healthcare has patent rights, for the treatment of HIV/AIDS in Rwanda. This consent was granted under Canada's Access to Medicines Regime which reflects the WTO '31f' agreement. This enables governments to authorize the production of certain patented medicines for export. ViiV Healthcare agreed to waive royalties on the basis that Apotex's triple combination generic ARV will be supplied on a not-for-profit basis. ViiV Healthcare's licensees supplied 439 million tablets of their versions of Epivir® and Combivir® to Africa in 2009. This represents more than 60% growth over 2008.;. This trend is welcome as it gives customers in sub-Saharan Africa greater choice and contributes to better security of supply.

Merck & Co., Inc. is committed to seeking additional ways to reduce the cost of its ARVs and increase access for people living in the world's poorest countries and those hardest hit by the pandemic, including through working with external manufacturers and suppliers to achieve incremental efficiencies. In addition, to date Merck has granted royalty-free licenses of its ARV efavirenz to five generic manufacturers, of which four are currently on the market. All but one licensee donates a percentage of efavirenz net sales to Msizi (Cares) Trust, a charitable trust established to further the fight against HIV/AIDS in South Africa through the provision of preventative and educational programs.

Roche has committed not to file any new patents or enforce existing patents for any of its medicines in the UN-defined Least Developed Countries. Nor will it enforce existing patents for its antiretrovirals in sub-Saharan Africa. As a result, generic versions of ARVs can be produced in these countries, encompassing 88% of all people living with HIV.

In 2006, Roche committed to an 'AIDS Technology Transfer Initiative', to help local firms in Least Developed Countries and sub-Saharan Africa to manufacture second-line HIV medicines. Thirteen agreements have now been signed with entities from eligible countries and expressions of interest have been received from 41 more in 17 eligible countries. Roche has conducted assessment visits with 39 companies to determine timing and delivery of technical expertise. Roche expanded its program in 2008 to include training seminars for local manufacturers across sub-Saharan Africa, focused on the development of good manufacturing practices to improve locally-produced essential medicines - not just ARVs. The first two training seminars were attended by 56 delegates from 21 organizations.

 

Partners: Adcock Ingram in South Africa, Aspen Pharmacare in South Africa, Aurobindo in India, Cipla in India, Emcure Pharmaceuticals in India, Hetero in India, Matrix in India, Ranbaxy in India
Countries: Kenya, India, South Africa