강제실시 효과

2007년 태국 칼레트라, 에파비렌즈 강제실시 발동후
이전보다 3배정도의 환자들이 제네릭 약물 복용이 가능해졌다는 내용

Thailand figures reveal the benefit of compulsory licences
14 March 2008
Pharma Times
http://www.pharmatimes.com/WorldNews/article.aspx?id=13072

Activists in the USA who support Thailand’s decision to issue compulsory licences have been highlighting data which
demonstrates that the policy is proving to be highly effective in getting HIV/AIDS drugs to more patients in the
country.

Essential Action's Access to Medicines Project cites data from the Thai National Health Security Office’s sub-
committee for benefits and services development which gives details about the number of patients benefiting from two of
the first three drugs that were compulsory licensed in late 2006 and early 2007, namely generic versions of Merck & Co’
s Stocrin (efavirenz) and Abbott Laboratories’ Kaletra (lopinavir/ritonavir), both HIV/AIDS drugs.

The figures demonstrate that as of January this year, roughly 24,013 people were taking the generic version of
efavirenz, approximately three times more than were using the drug before the compulsory licence is issued. Essential
Action also notes that some 2,500 patients were being treated with generic lopinavir/ritonavir from India, again three
times the number using the higher-priced brand-name therapy before the Thai government’s move.

Regarding the third drug, a generic version of Sanofi-Aventis/Bristol-Myers Squibb’s antiplatelet blockbuster Plavix
(clopidogrel) has already registered by the GPO. It is produced by India’s Cadila Healthcare, and an order of the first
batch for two million tablets was placed.

Since then, four other compulsory licences have been issued on cancer drugs -Sanofi’s Taxotere (docetaxel),
Roche/Genentech’s Tarceva (erlotinib) and Novartis’ Femara (letrozole) and Glivec/Gleevec (imatinib), though the latter
licence was cancelled after the Swiss firm agreed to supply it free to hundreds of leukemia patients in Thailand. The
new government in Bangkok has suggested that it intends to continue with the policy, a move that has given rise to
fears that the USA and the European Union will step up pressure on the Thais to think again.

EU will not take Thailand case to WTO

However, Essential Action says that reports suggesting that the European Union is planning to file a case against
Thailand at the World Trade Organisation are untrue. The group says that when asked a plea to the WTO was in the
pipeline, an EU official stated that no challenge was or will be made and acknowledges that Thailand's actions are WTO-
compliant.

The official is quoted as saying that “the Commission has been in constant contact with the Thai authorities and has
stressed that compulsory licensing, while allowed by the WTO rules, should be regarded as a last resort option and that
negotiations and collaboration with pharmaceutical companies should be sought”. The EU is hoping that this will be the
line of the new government, the official said, however “it is clear that the Commission has never threatened WTO
litigation on compulsory licensing for medicines”.

Trade officials across the Atlantic have also denied that any trade sanctions are planned, although Thailand does
appear on the US Trade Representative’s current Priority Watch List for intellectual property transgressors.