Data Exclusivity and Access to Medicines – Empirical Evidence

1. Data Exclusivity and Access to Medicines – Empirical Evidence Hearing European Parliament: EU-India Free Trade Agreement: What Future for Patients in Developing Countries Date Presenter 10 February 2011 Katrien Vervoort

2. Data exclusivity? • Registration brand medicine: show safety and efficacy throug submission of clinical trial data • Registration of a generic medicine: show bioequivalence • DE: Forbids use of or referral to clinical trial data of originator company => Administrative barrier to marketing of generic drugs, even when no patent • Two choices for generic producer: • Repeat clinical tests: unethical + expensive • Wait… • Monopoly, even when not innovative.

3. Consequences for Access to Medicines: Empirical evidence • Jordan: • Oxfam 2007: All costs, no benefits: How TRIPS-plus rules in the US-Jordan FTA affect access to medicines. • Guatemala: • Center for Policy Analysis on Trade and Health, 2009: A trade agreement’s impact on access to generic drugs.

4. TRIPS-plus rules in the US-Jordan FTA 1) Data exclusivity 2) Restricted use of parallel importation 3) Restrictions on the use of compulsory licensing ** Study only examined consequences of data exclusivity

5. US-Jordan FTA The US Government claimed that TRIPS plus rules are beneficial in developing countries. Cited the US-Jordan FTA – particularly: • No public health deterioration • Increased local R+D • Numerous new, innovative product launches • Increased foreign direct investment

6. Oxfam study on US-Jordan FTA • Oxfam hired three researchers to collect data to either verify or rebut US government assertions. • 2 objectives: (1) To measure actual public health consequences of US-Jordan FTA since 2002 (through mid-2006) (2) To measure benefits

7. Overall findings 1) Medicine prices have risen 20% since 2002 and account for an increasing share of overall health care costs. 2) Many new medicines lacking a generic equivalent in Jordan from 2002-2006 were due to the imposition of data exclusivity (and not patent protection). 3) Few or no benefits due to US FTA – despite US claims. ** Only looked at data exclusivity, although the FTA restricts use of parallel imports and compulsory licensing.

8. Data exclusivity in Jordan • Analyzed 108 medicines launched onto the Jordanian market since 2001 (42% of all new, branded medicines launched and more than 70% of sales). • Only 5 medicines (of 108) had patent protection. • Of 103 medicines without patent protection, 79% had no generic competitor (despite the existence of generic competition elsewhere) due solely to data exclusivity. => Drug companies relied upon data exclusivity to function as patent protection.

9. Public Health Consequences? – comparison Egypt – Jordan (1) • Heart disease and diabetes are serious problems in Jordan and Egypt. • Prices for new medicines to treat cardiovascular disease and diabetes are two to ten times higher in Jordan than in Egypt.

10. Public Health Consequences? – comparison Egypt – Jordan (2) • Must qualify that other reasons – costs of APIs, currency shifts and surcharges could be responsible for price increases or lack of a greater price differential. • These medicines had no patent in Jordan or Egypt – only data exclusivity in Jordan prevented generic competition. => Increased health-care costs and less medical treatment, especially for poor people.

11. Medicine prices and TRIPS-Plus rules • Medicine prices increased by 20 percent since the country entered into an FTA in 2001: 2005 National Health Strategy: «the rise in the pharmaceutical bill represents one of the main challenges that face…continuation of health programmes…and sustainability of funding for those programmes. » • Many factors: new economies of scale, procurement negotiations, inflation, currency shifts.

12. Medicine prices and TRIPS-Plus rules • But also: Introduction of new medicines with no generic equivalent. Many remain unsold, some have captured a large share of the local market. Market share of medicines with no generic equivalent (2002-2006)

13. No benefits to TRIPS plus rules 1) Our study found local companies engage only in minimal R&D and are not inventing new medicines; 2) Little or no FDI into Jordan since 2001 - most new medicines are imported rather than produces locally via licensing agreements with multinational companies. (only 5% via licensing agreements) 3) Egypt – No TRIPS implementation until 2005 yet received 223 million USD of FDI (35% of all output due to licensing agreements with foreign manufacturers)

14. No benefits to TRIPS plus rules (2) 4) There have been new product launches in Jordan, but only a fraction of total product launches in US/EU. 5) Even when launched, mostly unaffordable – IMS data indicates few or no sales of most medicines. 6) Scientific offices: aggressive marketing methods

15. New studies on consequences of TRIPS-plus rules – Guatemala • CPATH, 2009 • Research question: Do CAFTA IP rules affect access to generic drugs in Guatemala? • => 77 brand-name drugs are affected by data exclusivity for either 5 or 15 years: contraceptives, diabetes, hypertension, cancer, HIV/Aids, etc.

16. Main findings • CAFTA IP rules affect the price of medicines: • Delayed entry of generics; • Reducedaccess to somegeneric drugs alreadyon the market; • Some data protectionexpiressooner in US than in Guatemala.

17. Guatemala: Brand name vs generic versions

18. Key lessons for EU-India FTA • Data exclusivity => Significantpriceincreases, even on the short term. • Jordan and Guatemala  India: Pharmacy of the developing world: 70% of all genericmedicines in DCs, 80% of ARVs • New challenges: • 2nd and 3rd line ARVs for HIV/Aids, rise of NCDs in developing countries,… • Financial and economiccrisis: constrained budgets; decrease of ODA => The world cannotafford the introduction of data exclusivity

19. Link to studies: • Jordan: http://www.oxfam.org/en/policy/bp102_jordan_us_fta • Guatemala: http://www.cpath.org/sitebuildercontent/sitebuilderfiles/cpathhaonline8-25-09.pdf

20. Katrien Vervoort Oxfam-Solidarity Belgium Email: kve@oxfamsol.be Phone: 0032 (0)2 501 67 56