JOINT STATEMENT ON
2nd LEAK OF TPPA INTELLECTUAL PROPERTY CHAPTER
KUALA LUMPUR, 20 October 2014 – Generic medicines save lives by preventing, curing and managing non-communicable and communicable diseases for all Malaysians, especially lower-income and marginalised groups. A majority of first line HIV medications are generic. Many cancer medications are patented and cost 2 to 3 times Malaysian household incomes.
The recent leak of the consolidated text of the Intellectual Property chapter has confirmed our fears that the United States would table 12 years of exclusivity for biologic medicines. Currently in Malaysia, Hepatitis C, gastrointestinal cancer, leukemia, and breast cancer, among others, are treated with biologic medicines. The provision would mean long monopolies, no generics, and high prices for each. It is largely unbracketed, meaning it is final, except for the number of years of exclusivity.
Throughout the text, it can be seen that many TRIPS+ provisions (rules that favour the pharmaceutical industry even more than the World Trade Organization’s rules) that will act to the detriment of Malaysian access to medicines are proposed by the United States and Japan and opposed by the other 10 TPP countries. One such proposal is that a Party may not deny a patent on the basis that the product did not result in enhanced efficacy. But patents should only be granted for new and useful inventions. A derivative of a known medicine may not qualify, especially if it is no more effective than the first. Malaysia has a right to deny such spurious patent claims.
We are also deeply saddened about the removal of a previous proposal on compulsory licences by New Zealand, Canada, Chile and Malaysia. Compulsory licences are issued by governments to order generic medications from India or other generic producers when the originator company is unable to supply medicines for Malaysian use, or is unwilling to lower prices for Malaysian consumption. The previous proposal which protected the use of compulsory licences is missing in this May 16 leak.
The leak also confirms that there will be differential treatment in regard to some provisions relating to medicines. TPP countries are divided into Category A, B and C, with A being the higher income countries (US/JP/SG), Category B middle-income (MX, BN) and Category C being Peru and Vietnam. We believe that categorization based on GNP per capita is arbitrary as it does not correlate with indications of household incomes, purchasing power, and disease burden. Transition periods or differential treatment that does not endure will not protect Malaysians from these harmful rules.
While we commend the Malaysian negotiators for remaining strong on some provisions, it is clear that the United States and Japan continue to be very real threats to access to generic medicines in Malaysia.
We call on the Malaysian government to:
• Reject all TRIPS+ provisions;
• Support 0 years for biologics exclusivity;
• Reintroduce the proposal protecting the use of compulsory licences; and
• Maintain transparency with Malaysian health and patient groups at all times.
“Most first-line medications for HIV are affordable generics, and this treatment has given enabled Malaysian patients to live normal lives. The provisions demanded by the United States in the latest IP chapter leak means that generics will be delayed for future medicines. The Malaysian government must hold strong against US demands, reject TRIPS+ provisions, and support 0 years of exclusivity for biologic medicines.”
Malaysian AIDS Council
“As a non-profit professional organization which focuses on empowering the community and increasing their health status, MIMPA is seriously concerned about the impact of the leaked TPPA provisions will have towards healthcare. We endorse the Joint Statement on TPPA Leak No 2.”
Dr Dhesi Baha Raja
Malaysian Integrated Medical Professionals Association (MIMPA)
“Patents and extended exclusivity are additional barriers for access to medicines for rare diseases. As it is there are many barriers to treatment due to a lack of research on orphan drugs. We are extremely concerned by the content of the leaked chapter.”
Dato’ Hatijah Ayob
Malaysian Rare Disorders Society
“Many Malaysian breast cancer patients depend on biologic medicines to survive. More years of exclusivity is a violation of their right to health and we urge the government to support 0 years of data exclusivity for biologics.”
Associate Prof. Dr Zaharah Aiyub
Breast Cancer Welfare Association (BCWA)
“The latest leak shows that developed countries continue to impose their standards on developing nations. The differential standard based on GNP per capita doesn’t take into account disease burden and earning capacity of our patients.”
Dick van der Tack
“Malaysia needs quality generic medicine to increase treatment coverage and save lives. This can be done only by ensuring a humane trade policy. This leaked chapter is not humane, and should not be seen as legitimate.”
Positive Malaysian Treatment Access & Advocacy Group (MTAAG+)
Further enquiries on this joint statement may be directed to:
Malaysian AIDS Council
Email: [email protected]
Phone (O): +603-4047312