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’s Concerns
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?
Other considerations
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.
By
MAKNA - Majlis Kanser Nasional/National Cancer Council
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