Access to medicines – B arriers relating to intellectual property rights and data exclusivity

1. Access to medicines – Barriers relating to intellectual property rights and data exclusivity Julian Cockbain & Sigrid Sterckx Yale conference Human rights & economic justice (18-20 Oct 2013)

2. Access to drugs 101 There are two sides to the issue: • New drugs for neglected diseases (covered for example by the HIF, but not our focus here) • Improved access to existing, on-patent or just off-patent, drugs

3. Barriers The barriers are NOT primarily the existence of patents in non-industrialized countries, but rather: • The difficulties faced by manufacturers in countries with manufacturing capabilities, but in which the patents exist, in manufacturing drugs for the non-industrialized countries. • The difficulty of getting regulatory approval in the non-industrialized countries when the patentee does not approve. • The use of ‘evergreening’ strategies by the patentee to delay the entry of generics .

4. Barrier 1: Manufacturing capacity • Few countries, especially non-industrialized countries, have pharmaceutical manufacturing capacity. Thus, even if there is no national patent, there is no way to have the drug manufactured locally. • When asked ‘which countries do we patent our possible new drug in?’, the standard response is ‘where the market is worth the expense (now or within the next 20 years) AND in all countries with pharmaceutical manufacturing capability’. • DOHA does not solve the problem.

5. Barrier 2: Regulatory approval • Countries jealously guard their rights to grant regulatory approval for a drug. • Understandable, but inefficient. • The drug originator maintains control – she has the data (and exclusive rights to it!! so-called ‘data exclusivity rights’). • But national regulators couldaccept recognition elsewhere as sufficient for local marketing by anyone.

6. Barrier 3: Evergreening • When a major profit-earning drug is coming towards the end of its patent cover, pharma uses all the techniques available to ensure that their own drug(s) remain the only ones that make major market sales. • Understandable – of course - but why should non-industrialized countries roll over and play dead?? • Indeed, why should any country? The patent monopoly has come to an end, the country has met its side of the bargain by excluding competitors during the patent’s life. Why allow the drug to continue to be sold at a price that is far above production cost???

7. Barrier 3: Evergreening (2) • Data exclusivity • Trade mark protection for product appearance • New, minor formulation tweaks • Relinquishment of regulatory approval for the first version • Patenting of the efficient manufacturing processes • Use of scale of manufacture efficiency to offer prices below those initially attainable by the generics manufacturers • Scare stories that the generic is not ‘the real thing’ • And many other techniques …

8. Our policy suggestions (1) • Non-industrialized countries should accept regulatory approval in Japan, US or EU and, on that basis, grant local regulatory approval to anyone who applies.

9. Our policy suggestions (2) • Nations with manufacturing capacity should amend their patent laws to exclude both manufacture for exportation and exportation from being patent infringements. In view of the WTO TRIPS Agreement, this would have to be for ALL products. Nonetheless, it is in line with the rationale behind patents – to promote the launching of new products onto the local market. • If even one country, with manufacturing capability and the strength to stand up to the USTR and 301, did this, it would be enough.

10. Our policy suggestions (3) • Where companies surrender their regulatory approval (in favour of a newer, patented, product), non-industrialized countries should still recognise the earlier approval – unless the approving authority has revoked that approval on health/safety grounds.

11. Our policy suggestions (4) • Promote generic uptake • Collaborate with other countries to achieve greater bargaining power when setting prices • Require the technology transfer envisaged by TRIPS and set up local/regional manufacturing capacity • Prevent local elites/decision makers from having a financial interest in continued sales at inflated prices. • Etc.

12. Do these suggestions violate TRIPS? • As far as we can see, all our suggestions would be TRIPS-compliant • Article 27 : ‘[P]atentsshall be available and patent rights enjoyable without discrimination as to the …field of technology’. • Article 39 :‘Members, when requiring … the submission of … data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use.’

13. Thank you for listening! julian.cockbane@btopenworld.com sigrid.sterckx@ugent.be