Access to Medicines at the World Health Organization

1. Access to Medicines at the World Health Organization A quick 10 year overview

2. History Lesson • ‘70ties Primary Health Care • 1975 WHA resolution calling on WHO to assist countries • 1977 1st Essential Drugs List published – contained 207 items • Selection and provision of medicines core function of government

3. Essential Drugs ’70 – ‘80 • “a peaceful revolution in international health” (E. Lauridsen) • Nevertheless a controversial concept • Pharma concerns: gov intervention in freedom to operate • Decisions what to pay for • IP – Andean countries excluded essential drugs from patentability

4. Essential medicines • 1977 WHO definition of “essential medicines” was that they were ‘of utmost importance, basic, indispensable, and necessary for the healthcare needs of the population’ • Current: ‘Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility.’

5. From EDL to RDS • 1985 Nairobi conference on drug policy • ED List – not enough. NGOs advocating for :”access to medicines AND rational use” • HAI: WHO medicines policy should go beyond making lists and regulate how medicines are marketed and used • WHO DG Dr. Mahler promised: “Strategy for strengthening WHO’s activities in support of the action required to make drugs more rational throughout the world”

6. Revised Drug Strategy • May 1986 World Health Assembly adopted the RDS which contained a series of strategies to • Increase availability of essential medicines • Improve the use of medicines (“Rational use of Drugs”) • Established the concept of “essential medicines” • Rooted in the promotion of generics Patents /IP issues not on the table!

7. Meanwhile at the GATT …. • Drug companies established an elite, high powered lobby group to ensure intellectual property issues would be part of the GATT framework • Gatt became the …

8. 1995

9. 1995 Changed IP Environment

10. WHO and WTO • 1996 WHA – health ministers for the first time discussed effects of international trade agreements on access to medicines • Public health advocates called for a role of WHO – Gatt negotiations carried out without regard to health needs • RDS resolution gave WHO mandate to work on IP – but US and Europe continue to object • 1998 Red Book …. Became the Blue Book • 1999 IP was a core issue in RDS discussions at the WHA

11. Seattle ‘99

12. Health at the WTO • TRIPS Council • 2001 Doha Declaration on TRIPS and Public Health • 2003 August 30 decision to amend the TRIPS

13. Effect of Generic Competition Source: http://www.msfaccess.org/fileadmin/user_upload/diseases/hiv-aids/Untangling_the_Web/Untanglingtheweb_July2008_English.pdf

15. $$$

16. WHO and trade debates • 1999 RDS changed to include work on trade (IP) • 2001 Big Pharma vs. Mandela • 2002 affordability criteria for inclusion in EDL challenged by NGOs • 2002 ARVs included in EML • 2006 CIPIH Report Published • 2006 – 2008 IGWG negotiations => GSPOA adopted • Implementation starts => eg. Medicines Patent Pool

17. Where are we now? • NGOs played a key role in pushing the agenda both at WHO and WTO • WHO no longer sole multilateral player in health • Progress on IP and health  • I+A agenda needs shaping up • New paradigms for R&D funding

18. Thank you!