Author: Daniele Dionisio
Position: Director, Infectious Disease Division, Pistoia Hospital, Pistoia, Italy
Institution: Pistoia Hospital, Pistoia, Italy
E-mail: d.dionisio@usl3.toscana.it
Additional Authors: Daniela Messeri, Assistant M.D., Division of Infectious Diseases, Pistoia Hospital, Pistoia, Italy
Submitted Date: August 30, 2007
Published Date: August 30, 2007
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

Compulsory licensing (CL) has brought antiretrovirals (ARVs) within reach in the developing world but has resulted in pressures by wealthy country industries and governments. Therefore, less risky solutions to maximize equitable access should be sought.

On a world perspective, multiplying South-South partnerships and enhancing research and development (R+D) leadership of multinational research-based corporations are concurrently emerging as leading phenomena in ARV drug sector: - New South-South partnerships addressing the building and output of antiretroviral (ARV) drug plants (also as regional companies to become cost-effective and stronger in resisting pressures) were recently signed or announced in Africa between governments (Mozambique-Zimbabwe, Mozambique-Brazil) or generic companies (Ugandan Quality Chemicals-Indian Cipla Pharmaceuticals). They fall into African Union’s plans (adding to already working examples), while strengthening generic companies competitiveness and entailing erosion of profits and markets for brand-name enterprises. For leading counterpart in agreement, instead, these partnerships do mean market expansion (including royalties and revenues from sales of active pharmaceutical ingredients-APIs), while for the other counterpart they represent self-sufficiency in pharmaceutical manufacturing, escape from dependence on countries with a 'colonial past', sustained drug supply to home market, domestic employment increase, as well as discounts for APIs.

On the other side, research-based multinationals still keep on with unrivalled R+D and new drug discovery leadership. This does imply that patent rights exploitation, control of prices, attraction power and prestige on the world market will be kept on by them indefinitely. Actually, this links up with R+D investments multinational research-based companies are exceedingly making in China and Singapore where mutual trade interests do secure substantial incentives.

On the whole, awareness of these scenarios, coupled with TRIPS and TRIPS-plus obligations, should definitely spur generic manufacturers into boosting innovation for new drugs discovery too. This would help gain wealthy markets while enjoying advantages from patent protection adoption. On these perspectives, why should generic manufacturers insist on CL rather than fuelling voluntary licensing (VL) with brand-name industry to exploit entwined know-how, training and technology transfer for new ARVs production?

Absolutely, these opportunities would help generic companies fast achieve high-level innovation performances. Conversely, threats to profits by CL and South-South partnerships are expected to push brand-name corporations into more VL deals with generic competitors (adding to already signed ones) to secure mutual advantages, while keeping leadership and delaying wealthy markets forays by generic firms. Overall, dynamics here may explain the generic and brand-name industry’s confluent interest towards VL.

Definitely, these agreements should include combination incentives and brokerage by World Health Organization to secure both most affordable prices and most equitably expanded access to ARVs in the sake of the worst-off as well.