MTAAG+ Memorandum to Human Rights Commission of Malaysia
Online Publication Date: 09 February 2012
Submission to SUHAKAM on the Impact of FTAs on the Right to Health
3 February 2012
Introduction
The Positive Malaysian Treatment Access
& Advocacy Group (MTAAG+) is a group of people living with HIV/AIDS (PLHIV)
doing HIV/AIDS treatment literacy and advocacy and networking. The Ministry of
Health has reported a total number of 91,362 PLHIV in Malaysia.[1]
As we represent many Malaysians living with HIV/AIDS, we are very concerned
that the life-saving medicines we need may become unaffordable if Malaysia signs
the free trade agreements (FTAs) it is currently negotiating with the United
States via the Trans Pacific Partnership Agreement (TPPA), and with the
European Union.
The price of patented medicines in Malaysia
are already high enough to be of concern. For example a 2005 study using WHO
methodology found that for a family of three receiving the lowest level of
Malaysian civil servant salary, it would take two-months’ salary to pay for one
month of patented medicines.[2] Similarly,
an article by Azmi and Alavi found that patented medicines can be 1,044% more
expensive than their generic equivalents in Malaysia.[3]
The Malaysian government is already struggling to provide all the HIV/AIDS
medicines required for free.
Since the negotiating texts have not been
disclosed, we have been unable to determine the obligations in the TPPA and
EU-Malaysia FTA that could affect our right to health, including our access to
affordable medicines. However, based on past US free trade agreements (FTAs) we
are worried that the TPPA will contain stronger intellectual property and other
provisions that will negatively impact our health.
Prior to May 2007,
the intellectual property chapters of USFTAs alone contained many obligations
which, if imposed on Malaysia, would harm our health. A table listing some of
these provisions, their impact on medicine prices and the UN Special Rapporteur
on the Right to Health’s recommendation on them is below.
Table
1: TRIPS+ provisions and UN Special Rapporteur’s specific recommendations
|
USFTA
provision
|
Impact
on medicine price
|
UN
Special Rapporteur’s recommendation to developing countries
|
|
Join the Patent Cooperation Treaty (PCT)
|
More medicines will be patented (based on
the experience of other countries which joined the PCT).
Patented medicines have cost US$15000 per patient per year instead of US$80
per patient per year for generics.
|
Establish high patentability standards
(which would not be possible under current proposals at the PCT)
|
|
Requiring patents on new uses of existing
medicines
|
Would
cause an 8% increase in medicine prices in Colombia by 2020
|
Exclude patents on new uses
|
|
Prohibiting pre-grant patent oppositions
|
Likely to mean that more medicines are
patented for longer and patented medicines have cost US$15000 per patient per
year instead of US$80 per patient per year for generics.[9]
|
Allow pre (and post) grant opposition
|
|
Requiring longer patent terms
|
Korean
National Health Insurance Corporation estimates it will cost US$757 million
if it has to agree to a four year extension in its USFTA negotiations.[10]
|
The extension of patent life in
developing countries can significantly impact the ability of patients to
access medicines, and may pose a burden for national health budgets
|
|
Limiting the grounds on which compulsory
licences could be issued
|
World
Bank estimated that if Thailand uses compulsory licensing to reduce the cost
of second-line antiretroviral therapy to treat people living with HIV/AIDS by
90%, the government would reduce its future budgetary obligations by US$3.2
billion discounted to 2025.[11]
|
Allow all possible grounds for compulsory
licences
|
|
Prohibiting parallel importation
|
Depends on the price at which it is
available elsewhere
|
Allow parallel importation
|
|
Requiring data exclusivity (DE)
|
·The prices of medicines which received data exclusivity in Guatemala are much
more expensive than non-protected drugs in the same therapeutic class. For
example, the
insulin Lantus costs 846% more than non-data protected isophane insulin.
·8 years of data exclusivity alone in Canada would have added $600
million to prescription medicine costs alone in the last five years.[13]
·DE would
require Colombia to spend an additional US$675million per year by 2020 and
US$989million per year by 2030.[14]
If this is not spent, Colombians will have to reduce their medicine
consumption by 30% by 2020.[15]
|
DE
raises ethical concerns of replicating trials on human populations and it
deters and considerably delays the entry of generic medicines and can lead to
the maintenance of high prices of medicines
|
|
Linkage of medicine registration to
patent status
|
Linkage would require increased spending by
Colombia of US$53million per year by 2030.[16]
|
Developed
countries should not encourage developing countries to enter into TRIPS-plus
FTAs. (And the WHO recommends avoiding linkage).
|
Additional
studies on the impact of TRIPS+ provisions on medicine prices
The World
Health Organization (WHO) has an economic model of the impact of provisions
which provide stronger intellectual property protection than the World Trade
Organization’s Agreement on Trade-Related aspects of Intellectual Property
Rights (TRIPS) requires (known as ‘TRIPS+’) on medicine consumption. The model
predicts that the full impact of medicine price rises will not be felt until
about 15 years after the USFTA begins because the stronger IP protection only
applies to each new medicine after the FTA starts so it will not affect all
medicines in a country and the overall medicine price until about 15 years has
passed.
When the
WHO model was applied to Colombia, it found that the effect of most of these
TRIPS-plus provisions (prior to May 2007) is that Colombia would require an
extra US$1.5billion to be spent on medicines every year by 2030.[18] If this
were not spent, Colombians will have to reduce their medicine consumption by
44% by 2030.[19]
A study of
the impact thus far of the TRIPS-plus provisions of the Jordan-USFTA found
that: one hospital alone has increased its medicine spending six-fold, medicine
prices in Jordan have already increased 20% since 2001 when the FTA began, over
25% of the Ministry of Health’s budget is now spent on buying medicines, data
exclusivity has delayed the introduction of cheaper generic versions of 79% of
medicines launched by 21 multinational companies between 2002 and mid-2006 and
ultimately the higher medicine prices are threatening the financial
sustainability of government public health programs.[20]
However, other countries could expect worse outcomes because recent USFTAs can
have twice as many provisions that are likely to delay the introduction of
cheaper generic versions of medicines as the Jordanian one and the Jordan-USFTA
has not yet been in force for the approximately 15 years the WHO’s model
predicts it will take for the full effects to be felt of these provisions on
medicine prices.
We were very encouraged when the Malaysian
Government issued a compulsory license in 2003 to import some generic
antiretrovirals (ARVs) to treat HIV/AIDS from India for use by the Ministry of
Health (MOH). The average monthly treatment cost by government hospitals and
clinics fell by 81% from US$315 to US$58 and more than doubled the number of patients who
could be treated.[21] The MOH has achieved 9,962 people to be on ARV therapy. But this is
still below the targeted 26,700 patients that needed urgent treatment with new
WHO treatment guideline with CD4 350 and below.
The Thai
Government (amongst others) recently issued compulsory licences for three types
of medicines and estimates that it could save it up to US$24million each year.[22] However a
number of provisions in a TPPA could prevent the use of compulsory licences,
including data exclusivity and linkage.
Human rights obligations
According to the UN Special Rapporteur,[23] access to
medicines forms an indispensable part of the right to health and States have an
obligation under the right to health to ensure that medicines are available and
financially affordable. Developed States also have a responsibility to take
steps towards the full realization of the right to health through international
assistance and cooperation.Moreover, all States parties to the
International Covenant on Economic, Social and Cultural Rights have a legal
obligation not to interfere with the rights conferred under the Universal
Declaration of Human Rights and the Covenant, including the right to health.
The UN Special Rapporteurs on the Right to
Health have repeatedly expressed concerns about these provisions. For example,
Anand Grover said that ‘TRIPS and FTAs
have had an adverse impact on prices and availability of medicines, making it
difficult for countries to comply with their obligations to respect, protect,
and fulfil the right to health’. [24]
His
predecessor, Paul Hunt, said he was ‘deeply concerned that the US-Peru trade
agreement will water-down internationally agreed health safeguards, leading to
higher prices for essential drugs that millions of Peruvians will find
unaffordable’. He stated that ‘The US-Peru trade agreement must not restrict
Peru's ability to use the public health safeguards enshrined in TRIPS and the
Doha Declaration . . . Both the US and Peru must honour these binding
obligations during their negotiations. If the final agreement has the effect of
restricting access to essential drugs it will be inconsistent with Peru's
national and international human rights obligations’. Mr Hunt concluded that
‘in accordance with its human rights responsibility of international
cooperation, the US must not apply any pressure on Peru to enter into commitments
that are either ‘TRIPS-plus’ or inconsistent with Peru's constitutional and
international human rights obligations’.[25]
Many others have expressed their concerns about the way the intellectual
property provisions found in USFTAs make medicines more expensive, including
the World Health Assembly,[26]
the WHO’s Commission on Intellectual Property Rights, Innovation and Public
Health,[27]
Ministers of Health from ten Latin American countries,[28] the
Ministers of Health[29]
of the African Union, the African Union’s Ministers of Trade[30],
the UK Government’s Commission on Intellectual Property Rights[31]
and Nobel Peace Prize winning Doctors Without Borders[32].
As a Party to the
Convention the Rights of the Child (CRC), Malaysia is bound by Article 24 of
the Convention which sets out the right of the child to the highest attainable
standard of health and includes an obligation on the Malaysian Government to
ensure the provision of health care to all children[33].
Furthermore, according to the Committee on the Rights of the Child, States
Parties have an obligation to provide antiretroviral medicines to HIV+ mothers
and children.[34] Malaysia
currently provides free antiretroviral therapy to HIV+ pregnant women and HIV+
children.[35] However
the sustainability of this assistance is already proving difficult and the permanently
lower government revenue as tariffs are reduced under the TPPA
and TRIPS+ provisions are likely to further threaten Malaysia’s ability to
fulfill this human rights obligation.
The Committee on the Rights of the Child
has already asked pointed questions as to how Malaysia will ensure that FTAs do
not affect the provision of generic medicines, especially for HIV/AIDS.
The Committee has expressed concern over the way in which TRIPS+ provisions in other
USFTAs may harm access to affordable medicines and has repeatedly urged
countries negotiating such agreements to ensure they do not negatively affect
the right of children to access affordable medicines.
The United States has reaffirmed its
support for the full use of TRIPS flexibilities in the 2010 United Nations
General Assembly resolution on the Millennium Development Goals.
(In 2006 the General Assembly’s resolution on HIV/AIDS also reaffirmed the
right to use all the safeguards in TRIPS and assist developing countries to use
these flexibilities).
We were encouraged to read that ‘President-elect Barack Obama and Vice President-elect Joe Biden believe
that people in developing countries living with HIV/AIDS should have access to
safe, affordable generic drugs to treat HIV/AIDS. They will break the
stranglehold that a few big drug and insurance companies have on these
life-saving drugs. They support the rights of sovereign nations to access
quality-assured, low-cost generic medication to meet their pressing public
health needs under the WTO’s Declaration on Trade Related Aspects of
Intellectual Property Rights (TRIPS).’ We look forward to seeing this
implemented by President Obama ensuring that any TPPA only has TRIPS-level of
intellectual property protection.
The European
Union (EU) is also likely to ask Malaysia for similar TRIPS+ provisions.
However the EU has given other developing countries (with gross national
incomes/capita which are higher than Malaysia’s according to the World Bank)
free trade agreements (FTAs) with no intellectual property (IP) chapter at all,
ie no TRIPS+ provisions. We therefore do not see why Malaysia should agree to
an IP chapter in any EUFTA at all.
No generic medicines means no access to
affordable life-saving AIDS drugs. This will translate to more deaths for
PLHIV. In
Malaysia, figures in December 2010 show that there are 91,362 reported cases of
HIV infection, and 16,352 AIDS cases in Malaysia. We have already lost 12,943
lives.
For PLHIV, the treatment that we need is
lifelong treatment. For us, it is a matter of life and death. As such:
·We strongly appeal to SUHAKAM
to safeguard our human rights to life, health, affordable medicines and
treatment.
·We urge SUHAKAM to conduct a
human rights impact assessment of the FTAs, including on the right to health.
·We call on SUHAKAM to also take
this matter up with the government and to ensure that the latter does not
include in any FTA an intellectual property chapter or any TRIPS+ or other
provisions that will harm the health of Malaysians.
Without ARVs, more PLHIV will die.
Edward Low,
President,
Positive Malaysian
Treatment Access & Advocacy Group (MTAAG+)
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