Thailand holds drug giants over a barrel

September 22, 2015

The Thai health ministry is considering which drugs Thailand needs and will either make or buy generic copies while haggling for "appropriate" prices of patented versions.

Government officials say a discount from drug companies will ensure this will not happen and they say this should not be regarded as a threat, but a negotiation for the country's benefit.

The Health Ministry last week issued compulsory licenses for the heart disease drug Plavix, made by Bristol-Myers Squibb and Sanofi-Aventis, and Abbott Laboratories' Kaletra to treat HIV/AIDS.

Thai health officials say the licenses will save the country up to 800 million baht ($24 million) a year, and while the move has been praised by AIDS activists, it has drawn flak from Washington and the drug industry, who are urging the ministry to rescind them.

The Thais say they will enforce the licenses if they fail to get the two patented drugs from the firms at prices they are prepared to pay.

The move would see a considerable drop in price for both drugs and make them available to a far wider population of sufferers.

Doctors Without Borders in Thailand support the government's action, saying a generic version of Kaletra would cut spending by two thirds.

Rumours that drugs which deal with cancer, cholesterol-reducing drugs and some anti-biotics are on the list have not been confirmed.

However reports that Rituxan, a big-selling drug for lymphoma, and a rheumatoid arthritis drug owned by Genentech are also under consideration appear to have more foundation.

World Trade Organisation (WTO) rules allow governments to declare a "national emergency" and license the production or sale of a patented drug without the permission of the foreign patent owner.

This is the procedure the Thai authorities are currently pursuing.

Maraviroc is the seventh Pfizer new drug application to receive "Priority Review" status from the FDA over the past two years. Other priority review FDA approvals include Sutent for advanced kidney cancer and gastrointestinal stromal tumors, Chantix for smoking cessation, Revatio for pulmonary arterial hypertension, and Macugen for age-related macular degeneration which can lead to blindness in elderly patients.

The marketing applications follow Pfizer's review of efficacy and safety data from two pivotal phase 3 trials. The trials, MOTIVATE-1 and 2 (Maraviroc plus Optimized Therapy In Viremic Antiretroviral Treatment-Experienced patients), represent 24-week data comparing Optimized Background Therapy, with or without maraviroc, in over 1,000 highly treatment-experienced patients with CCR5-tropic HIV-1. These study results have been accepted for presentation at an upcoming HIV conference.

In addition, the independent Data Safety Monitoring Board (DSMB) for maraviroc met on January 15, 2007 and continues to monitor the ongoing clinical program. The DSMB recommended that the maraviroc Phase 3 registrational trials, in both treatment-na??ve and treatment-experienced patients, continue as currently designed.

In December 2006, Pfizer announced plans to establish a multi-national Expanded Access Program to provide maraviroc to patients with limited available treatment options based on its safety and efficacy observed in clinical trials to date. The program is now open for enrollment with a target to enroll patients from over 30 countries.