The Global Access to Medicines Movement Peter Maybarduk April 15, 2011

Asunto central: Como podemos asegurar el acceso a los medicamentos y a la vez optimizar la innovación biomedica?

La Competencia y el Acceso (Médicos Sin Fronteras)

Access: Looking forward 2nd, 3rd line HIV/AIDS treatment Heart disease & cancer in developing countries. Expensive biologics. Generics producers bought out Patent regimes in developing countries

“Intellectual Property” U.S. Constitution, Article 1, Section 8, Clause 8, empowers Congress: –“To promote the Progress of Science and useful Arts, by securing for limited Times to authors and inventors the exclusive Right to their respective Writings and Discoveries” Natural right to control our ideas? Artificial concept of “IP”

Patents and IP in practice But who controls IP in practice? For how long? On what terms? Patents under WTO: 20 year exclusive right to control a technology Data exclusivity: right to control clinical trial data Drug monopolies

Global IP Norm-Setting WTO / TRIPS (1995) –New patent rules for many countries Doha Declaration (2001) –Pro-public health WTO interpretation of TRIPS –See also Clinton Executive Order (2000) Free Trade Agreements –EU-India, Trans-Pacific FTA Unilateral Pressure / Sanctions

TPP: Nuevo TLC, Acuerdo Estrategico Trans-Pacifico Express goal of USA: APEC members. 21 countries; 40% of world’s population Consider precedent; shifts for global rules

(Melbourne Round)

Goal: I+A & uso racional de medicamentos –Innovation plus access and rational use. How do we get there? –Competition: Flexibilities in IP rules –Alternative financing methods for neglected diseases –Positive agenda on quality & rational use The big idea: “Delinkage.” Separating manufacturing costs from R&D.

I+A Licensing and competition –Global licensing campaign –Licensing of federally funded inventions –Medicines Patent Pool Foundation Multi-faceted innovation system –Prizes –Public research & funding –Global R&D Treaty

Las Licencias Uso gubernamental y las licencias obligatorias Autoriza la competencia con los medicamentos patentados Derecho soberano siguiendo la OMC Necesario para: Reducir costos, y así aumentar los servicios de salud y el acceso a medicamentos. Facilitar la fabricación nacional.

Compulsory licensing Authorize generic competition with a patented medicine –Patent holder receives royalties Examples: Europe, USA, developing countries Ecuador, Colombia New UNAIDS, UNDP, WHO report

Que podemos hace nosotros?

Asunto central: Como podemos asegurar el acceso a los medicamentos y a la vez optimizar la innovación biomedica?

Peter Maybarduk

Data Exclusivity EU grants marketer of new medicine 8 years exclusive use of clinical data –EC Regulation 726/2004: years Anyone wishing to market the same medicine must duplicate clinical trials Results in ten year monopolies

Counterfeit legislation Laws misrepresenting their ingredients Some bills enforce monopolies rather than protecting drug supply –IP framework vs. DRA framework EC customs regulation 1383/2003 East African bills criminalizing generics

Positive Agenda Positive agenda on medicines quality assurance and rational use –Strengthen DRAs –Combat pharmaceutical fraud –Access to medicines –International cooperation –Private sector accountability –Public participation

Data exclusivity & compulsory licensing Data exclusivity could allow for exceptions in cases of compulsory licensing –Safeguard for competition to protect health But according to DG Enterprise: –“does not foresee any exception … in case of emergency … or compulsory license” Letter to EGMA 20 Feb Impermeable ten year drug monopolies for EU members