The Business Circle reported on May 27, 2015 that with the TPP, Malaysia will theoretically gain access to a market of 800 million people with a combined GDP of US$27.5 trillion. The Peterson Institute of Economics says Malaysia stands to gain over US$41.7 bil (RM133.9 bil) increase in exports and US$26.3 bil in income gains by 2025 if it stays on the TPP track.
To date, Malaysia has not signed the TPPA yet. However, our Ministry of International Trade and Investment have, together with countries such as Australia, Brunei Darussalam, Canada, Chile, Japan, Mexico, New Zealand, Peru, Singapore, United States, and Vietnam, “… successfully concluded the Trans-Pacific Partnership. After more than five years of intensive negotiations, we have come to an agreement that will support jobs, drive sustainable growth, foster inclusive development, and promote innovation across the Asia-Pacific region. Most importantly, the agreement achieves the goal we set forth of an ambitious, comprehensive, high standard and balanced agreement that will benefit our nation’s citizens.”
It would seem that Malaysia is intent on signing the trade agreement. And this is of great concern for non profits and social enterprises that serve communities needing financial and health support. So far the agreement has been very controversial in all the countries involved, particularly in Malaysia there are big Concerns regarding protection for local industries, local agriculture and Generic Medicines Industry and prices.
MAKNA, the social enterprise which provides support for cancer patients and their families (Majlis Kanser Nasional or National Cancer Council), is concerned by the country’s move towards the TPPA. While international trade is an important contributor to Malaysia's economic growth and development and that Malaysia's trade policy is to pursue efforts towards creating a more liberalised and fair global trading environment, there are serious concerns for MAKNA and other social enterprises who serve their communities.
Social enterprises and NGOS are given conflicting arguments. Several members of Local Pharmaceutical industry, Academic, Medical & Scientific communities and civil society have expressed concerns that some specific clauses on the agreement will have a direct impact in drug prices by extending patents protection time and limiting capacity for access to generic medicines. Yet on the other side members of the Malaysian government have told that there will no impact in price medicines and that the necessary legislations will be designed in order to protect access to low price medicines.
“About 80% of medicines sold in Malaysia were generics, which meant prices would likely rise sharply under the TPPA, The trade agreement would create strict curbs on the sale of generic medicines as Western pharmaceutical companies seek to strengthen protection of their patents and intellectual property rights. It will be harder to obtain generic medicines because under the TPPA, most of the medicine that will be sold will be ‘genuine medicine, prices for all sorts of medicines, including antibiotics, for HIV, diabetic and cancer medication, will rise sharply if there are no generics available,” a member of the medical fraternity said.
Minister Datuk Seri Mustapa Mohamed said in an open letter:
“The patent protection for pharmaceutical drugs remains at 20 years, consistent with the WTO trade related aspects of intellectual property rights (TRIPS) agreement, Only in the event there is an unnecessary delay in patent or marketing approval will the patent period be extended. Let me state clearly that Malaysia’s current process of patent and marketing approval for drugs is efficient and hence the likelihood of patent extension will not arise. Therefore, the allegation that the patents clause will result in the price of medicine increasing because of TPP is not accurate. The test data protection regulation in Malaysia, however, has conditions that must be met by the innovator. For example, the innovator has to apply for registration of pharmaceuticals in Malaysia within 18 months from the date the product obtained its first marketing approval in any other country.”
Which is which?
MAKNA is the “end user”. We buy the drugs on behalf of the patients, so if there is price increase coupled with GST and the devaluation of the ringgit, it will adversely affect our budget (it costs more to help the same amount of people). The price of drugs will be affected - Canada Economic Trade Agreement) saw a rise from 6-12% over the course of the years with the implementation of CETA. Can you imagine a similar situation in Malaysia, when Malaysians do not earn the income advanced countries do?
Accessibility to the patented drugs is another concern. 82% of generic drugs are in public hospitals.
What about the supply and demand to affect price of those drugs? This is somehow not assuring to those who are with chronic illnesses.
There are other questions that need to be addressed and they are:
What are the measures to lessen that burden coupled with GST and devaluation of the ringgit
· How is the TPPA different from previous years trade agreement ( during Tan Sri Rafidah Aziz time?) What was the outcome of those trade agreements specifically in price of drugs and patent laws. What is the data on that?
The trade agreement includes evergreening, under the TRIPS clause, which is Flexibility is important because it allows governments to prohibit so-called “evergreening, which enables pharmaceutical companies to extend the patent life and monopoly protection of old drugs by making minor modifications to existing formulations or dosages, without necessarily increasing the therapeutic efficacy for patients, or by identifying a new therapeutic use for an existing medicine.
Even more frightening are the intellectual property provisions that can facilitate evergreening if a country doesn’t have the appropriate IP legislation. In addition to patent extensions, the text contains a controversial provision in the intellectual property chapter, requiring five or eight years of data exclusivity for biologic medicines.
Many cancer medications are biologic, including the breast cancer drug Herceptin which costs RM8,000 (US$2,600) per cycle with 17 cycles of treatment needed, costing a total of RM136,000 (US$44,000) for the entire treatment.
All these at the cost of human lives?
This is our concern in the industry especially for the Not For Profits. I am sure if we were to delve deeper and into other sectors, more issues would be apparent and requires the government’s responds over the concerns. The not for profit sector needs time to conduct their due diligence too in any trade agreements when it affects the end users choice and accessibility to life saving drugs.
MAKNA - Majlis Kanser Nasional/National Cancer Council