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Intellectual Property Rights Series
Malaysia’s Experience in
Increasing Access to Antiretroviral
Drags: Exercising the
‘Government Use’ Option
Chee Yoke Ling
TWN
Third World Network
9
Malaysia’s Experience in Increasing Access to
Antiretroviral Drugs: Exercising the ‘Government
Use’ Option
Chee Yoke Ling
TWN
Third World Network
Malaysia’s Experience in Increasing Access to Antiretroviral Drugs:
Exercising the ‘Government Use’ Option
is published by
Third World Network
131 Jalan Macalister
10400 Penang, Malaysia.
Website: www.twnside.org.sg
E-mail: twnet@po.jaring.my
© Third World Netw ork 2006
Printed by Jutaprint
2 Solok Sungei Pinang 3, Sg. Pinang
11600 Penang, Malaysia.
ISBN: 983-2729-61-0
CONTENTS
1
Background
5
2
Access to ARVs
7
3
From Negotiations to Government Use
11
15
‘Adequate Remuneration’
4
The Next Step: Encouraging Domestic Manufacture
and Using TRIPS Flexibilities
Bilateral Free Trade Agreements
Government Use in Indonesia
Conclusion
17
18
19
20
APPENDICES
21
Appendix 1: Form 11, Patents Act 1983: Application for Compulsory
Licence (Patents Regulations 1996 - Regulation 38) (Malaysia)
21
Appendix 2: Authorisation for exploitation of patented invention in
Malaysia under Section 84(1 )(a), Patents Act 1983
(‘Government Use’ provision)
23
Appendix 3: Open letter to Prime Minister Datuk Seri Abdullah
Ahmad Badawi - Appeal for Malaysians to have access to affordable
medicines (3 March 2006)
25
Appendix 4: Presidential Decree No. 83 of 2004 Regarding
Exploitation of Patent by the Government on Anti Retroviral
Drugs (Indonesia)
27
NOTE:
This paper is based on data and information from the Pharmaceutical Services
Division, Ministry of Health, Malaysia.
1 Background
MALAYSIA has a population of 24 million. In the period 1986 to June 2005,
the number of recorded HIV patients was 63,438 while AIDS patients num
bered 10,044. Recorded AIDS deaths were 7,673. There are already 15,000
children orphaned by AIDS in the country.
The World Health Organization in June 2005 warned that an HIV epidemic is
knocking on Malaysia’s door1. The figures, according to health authorities and
NGOs, are a conservative estimate.
The budget in 2003 for pharmaceutical drugs of the Malaysian Ministry of Health
(MOH) was USD 193.6 million, of which USD 3.6 million was for antiretroviral
drugs (ARVs). Since prices of ARVs are high, and about 75% of the HIV posi
tive persons are intravenous drug users who largely cannot afford treatment, the
MOH was faced with the challenge of increasing access to affordable ARVs.
In facing the challenges of HIV/AIDS through the provision of antiretroviral
drugs, the MOH underwent an experience that may be useful for other develop
ing countries.
At the initiative of the MOH, in 2003, Malaysia became the first country to
issue a compulsory licence following the adoption of the Doha Declaration on
the TRIPS Agreement and Public Health by the 2001 Ministerial Conference of
the World Trade Organisation (WTO).
1 UNAIDS/WHO Report on the Global HIV/AIDS Epidemic 2004
The Declaration reaffirmed the rights, flexibilities and safeguards vested in WTO
Members by the Agreement on Trade-Related Aspects of Intellectual Property
(TRIPS). One of these is the use of compulsory licences on grounds to be
determined by national law.
The ‘Government Use' or ‘public non-commercial use’ option can be described
as a special type of compulsory licence, whereby there is no need to have prior
unsuccessful negotiations with the patent holder before authorising the import
or manufacture of the subject matter of a patent.
Thus for the purposes of ensuring access to medicines, a government or a third
party (contractor) authorised by the government can import or manufacture a
generic version of a patented drug for ‘public non-commercial use’. This means
the use of those drugs in public hospitals and clinics.
6
2 Access to ARVs
THE ARVs2 in the Malaysian MOH Drug List and their patent status are as
follows:
1.
Nucleoside reverse transcriptase inhibitors (NRTI)
Stavudine (not patented)
Didanosine (patented)
Zidovudine + Lamivudine combination (patented)
2.
Protease Inhibitors
Ritonavir (not patented)
Indinavir (patented)
3.
Non-nucleoside reverse transcriptase inhibitors (NNRTI)
Efavirenz (patented)
Nevirapine (not patented)
Malaysia’s practice in providing access to ARVs at that time was as follows:
1.
Monotherapy was free in MOH hospitals.
2
d4T (NRTI) alternative name Stavudine
ZDV (NRTI) alternative names Zidovudine or AZT
EFZ (NNRTI) alternative name Efavirenz
NVP (NNRTI) alternative name Nevirapine
3TC (NRTI) alternative name Lamivudine
2.
Triple combined drug treatment or Highly Active Antiretroviral
Treatment (HAART) was given free to:
(a) infected mothers after delivery';
(b) infected children;
(c) healthcare workers infected in the line of duty;
(d) patients infected through contaminated products/blood transfusion.
3.
Other patients on HAART were required to purchase two dings, with one
other drug provided free of charge.
According to the MOH, the payment requirement is to ensure commitment to
treatment. The other reason is that with an annual drug budget of USD3.5 mil
lion for H1V/AIDS treatment, the MOH is unable to give free full treatment.
However, the majority of patients are intravenous drug users (about 75%), many
of whom cannot afford to buy the ARVs and who have serious problems in
treatment compliance.
As a result of growing concerns over high prices of patented and non-patented
drugs in Malaysia, the MOH (in particular, the Pharmaceutical Services Divi
sion) started in 2001 to seek price reductions from pharmaceutical companies.
In July 2001 the following reductions in percentage terms were obtained as a
result of these negotiations:
1.
Non-patented ARVs:
Ritonavir capsule and oral solution (10%)
Stavudine (25% - 34%)
Nevirapine (68.5%)
2.
Patented ARVs:
Didanosine (36%)
Zidovudine (30%)
Zidovudine + Lamivudine combination (40%)
8
Indinavir (65%)
Efavirenz (65%)
However, negotiations with drug companies to effectively bring down prices
were not satisfactory; the reductions were still inadequate, and prices remained
too high.
It was at this juncture that Third World Network cooperated with the Ministry
of Health (with full endorsement of the then Minister of Health), to organise an
Expert Briefing on Parallel Importing and Compulsory Licensing on 16, Au
gust 2002?
The briefing provided information to relevant government agencies regarding
developments related to access to affordable medicines, intellectual property
rights and the WTO TRIPS Agreement.
TWN facilitated the participation of local and foreign experts on issues relating
to the Doha Declaration on the TRIPS Agreement and Public Health, patents
and access to affordable drugs as well as the options available to developing
countries such as compulsory licensing, parallel imports and 'Government Use’.
The use of compulsory licences in developed countries was highlighted.
In order to increase access to ARV drugs, the government adopted a HAART
policy in late 2002 with the following strategy:
1.
Provide free HAART to patients with CD4 count < 400. Target: 10,000
patients (there are 4,000 patients'1 on record and the government expects
more unregistered patients to seek treatment with the availability of free
drugs);
3
The Malaysian AIDS Council had earlier alerted the government to the compulsory
licencing and parallel import provisions under the Malaysian Patents Act 1983.
Before the government use/compulsory licence, the MOH could provide treatment to
only 1,500 patients. This number could be increased to 4,000 after the generic imports
from Cipla, a generic manufacturer in India, under the Government Use authorisation.
4
9
2.
3.
4.
10
Bring prices of HIV drugs down through negotiations with patent holders;
Encourage local production of HIV drugs that are not patented in Malay
sia;
Consider the use of the ‘Rights of Government’ under the Patents Act
1983 (i.e., the ‘Government Use’ option).
3
From Negotiations to
Government Use
THE Ministry of Domestic Trade and Consumer Affairs is responsible for in
tellectual property in Malaysia, and the administration of the Patents Act 1983.
The examination and granting of applications for patents and other intellectual
property claims lies with the Intellectual Property Corporation of Malaysia.
Sections 48 to 54 provides for compulsory licences (there is a prescribed form
under the Act for applications for a compulsory licence, which is simple to use:
see Appendix 1).
Sections 37(2) and 58A provide for parallel import, based on the international
exhaustion of rights principle.
Section 84 provides for the ‘Rights of Government’, the term for ‘Govern
ment Use’ in the Patents Act. There is no prescribed form required. A decision
of the relevant government authority is sufficient.
In November 2002, given the limitations of negotiations with drug companies,
and boosted by the Doha Declaration on TRIPS and Public Health, the MOH
submitted a paper to the Malaysian Cabinet with a recommendation to import
generic ARV drugs. The drugs concerned are patented in Malaysia.
The Cabinet approved on the basis of the government use provisions in section
84 of the Patents Act 1983.
Section 84(1) provides for the ‘Rights of Government':
‘Notwithstanding anything contained in [this] Act —
(a) where there is national emergency or where the public interest,
in particular, national security, nutrition, health or the development
of other vital sectors of the national economy as determined by the
Government, so requires: or
(b) where a judicial or relevant authority has determined that the
manner of exploitation by the owner of the patent or his licensee is
anti-competitive,
the Minister may decide that, even without the agreement ofthe owner
of the patent, a Government agency or third person designated by
the Minister may exploit a patented invention.’
The patent owner shall be notified of the Minister’s decision ‘as soon as is
reasonably practicable’. Section 84(3) provides for ‘the payment to the owner
of the patent of an adequate remuneration’.
In January 2003, the MOM began price negotiations with the representative of
the Indian company, Cipla, and applied for an authorisation from the Ministry
of Domestic Trade and Consumer Affairs which is responsible for intellectual
property. At this point, the opposition began.
GSK in February 2003 offered to drop the price of Combi vir by 57% after the
Cabinet decision to purchase drugs from India. In March, some other govern
ment agencies asked the MOH to reconsider their move, citing concerns that
such an action would deter foreign investors. At the same time, GSK met with
then Minister of Health.
In August 2003 the Ministry of Domestic Trade and Consumer Affairs sug
gested that the MOH does not use compulsory licensing.
12
In April GSK dropped the price of 3TC, AZT and Combivir by 31-57%. The
MOH decided to proceed first with the import of non-patented drugs. Thus in
May, the MOH issued contracts for Stavudine (USD5.54 per 60 tablets), Ritonavir
(USD90.21 per 120 tablets) and Nevirapine (USD21.91 per 60 tablets) to be
imported from India.
Meanwhile, the MOH stood firm on the imports under the ‘Government Use’
provisions and the Cabinet decision was reaffirmed. The authorisation for a
period of two years beginning 1 November 2003 was finally obtained from the
Ministry of Domestic Trade and Consumer Affairs for the import of AZT, ddl
and Combivir.
The drugs were:
1.
2.
3.
4.
Didanosine 100 mg tablet (patent holder: Bristol-Myers Squibb)
Didanosine 25 mg tablet (patent holder: Bristol-Myers Squibb)
Zidovudine 100 mg capsule (patent holder: GlaxoSmithKline)
Lamivudine 150 mg + Zidovudine 300 mg tablet (patent holder:
GlaxoSmithKline).
The conditions for the company assigned under the government use were as
follows (see Appendix 2):
1.
2.
3.
4.
5.
6.
The imported drugs shall be supplied to government hospitals only.
Every box of medicines shall be labelled with the words ‘MINISTRY OF
HEALTH’.
The brand name, shape or color of tablet or capsule shall be different from
the patented products in Malaysia.
The company shall keep records of sales in a Poisons Wholesale Book.
Compensation payment shall be paid to the patent holders within a period
of two months after every time the products are imported.
The permit shall be valid for two years.
13
The quantity to be imported was specified by the MOH. The Minister of Health
announced in November 2003 that the supply of HAART would be free once
the import of generics started.
GSK and Bristol-Myers Squibb lodged complaints against the Malaysian
government’s move after the issuance of the ‘Government Use’ authorisation.
Both companies used the threat of reduced foreign investment in the country,
and one of them also expressed concerns that Malaysia’s action would create a
precedent internationally.5
At the same time, there was wide national media coverage on the availability of
cheaper ARVs, a development that gained public support.
In February 2004, the MOH issued a contract to a local Malaysian company to
import generic Zidovudine, Didanosine and a combination of Lamivudine and
Zidovudine from generic manufacturer Cipla (India): see Annex 2.
The average cost of MOH treatment per month per patient dropped from USD315
to USD58, equivalent to about an 81% reduction, when generic drugs were
used. The number of patients who could be treated in government hospitals and
clinics increased from 1,500 to 4,000. The MOH target is 10,000 when there is
more awareness of the ARVs availability and more outreach by the public health
system to the needy patients.
As a result of the exercise of the right of government use, the patent holders
dropped their own prices. There has thus been a considerable reduction in cost
for the first and second line regimen ARVs, as seen in the tables on next page,
for use in government hospitals and clinics.
5
14
A law suit has even been filed in the Malaysian courts by one of the patent holders, and
it is still on record though not activated.
GlaxoSmithKline drops prices again from an earlier reduction in 2003
Combivir(60 tablets)
AZT(l00 tablets)
3TC(60 tablets)
2001 prices
(USD)
286.28
77.58
141.75
2004 prices
(USD)
57.99
36.08
46.39
% drop in price
80%
53%
67%
Source: Ministry of Health, Malaysia
Bristol-Myers Squibb drops prices of Didanosine
Didanosine (lOOmg)
(60 tablets
Didanosine (25 mg)
(60 tablets)
% drop in price
2001 prices
(USD)
63.55
2004 prices
(USD)
32.68
49%
44.49
8.17
82%
Source: Ministry of Health, Malaysia
Monthly Cost of Treatment Per Patient
Treatment
d4T + ddl + Nevirapine
Combivir + Efavirenz
2001 price
for patented
drug (USD)
261.44
362.63
2004 price
for patented
drug (USD)
197.10
136.34
2004 price for
generic drug
(USD)
45.32
115.14
Source: Ministry of Health, Malaysia
‘Adequate Remuneration’
Taking into account existing state practices and the UNDP Human Develop
ment Report 2001 recommendation, the MOH proposed to the patent holders a
remuneration level of 4% of the value of stocks actually delivered.
15
However, according to MOH officials, the patent holders ‘show no interest in
claiming compensation'.
The possible reasons that they have identified are:
1.
A precedent would be set for future government use/compulsory licence
remuneration in Malaysia and other countries.
2.
Bad publicity for the patent-holder, because they have accepted the prac
tice of issuing compulsory licences and agreed to receive less than full
royalties, thus setting an undesirable precedent from the industry’s view
point.
3.
Sign of acceptance of the rights of the MOH.
Thus there was no move on either side to proceed with negotiations on remu
neration as of February 2006. However, a court case was Hied when the govern
ment use authorisation was first issued, and this remains even though the patent
holder has not activated the lawsuit. Meanwhile, the period of the government
use authorisation has ended.
16
4
The Next Step: Encouraging
Domestic Manufacture and
Using TRIPS Flexibilities
CURRENTLY, the Malaysian government has a policy to encourage domestic
manufacture of non-patented drugs. In 2003 Stavudine and Nevarapine which
are not patented in Malaysia were registered for local production in order to
increase access to those drugs.
In February 2004, the MOH received a proposal from a local manufacturer to
manufacture a three-in-one ARV combination (Stavudine + Lamivudine +
Nevirapine). In October the local manufacturer approached GSK, the patent
holder, for a voluntary licence to use Lamivudine to manufacture the three-inone combination drug, the other two components being non-patented. Negotia
tions have been completed on the royalty payment of USD0.042 (16 Malaysian
sen) per tablet, i.e. 6.0 % of the price per tablet.
However, since only one of the three components is patented, assuming that
there are equal proportions of each component the actual royalty is 18% per
tablet. This is very high, especially when compared to the average remunera
tion rate of 4% for compulsory licensing that MOH had offered the same patent
holder in relation to the imports of generic ARVs from India.
The other conditions are not publicly known, as in the case of most voluntary
licencing arrangements.
Meanwhile, according to the MOH, patent holders are more cooperative now
compared to the earlier period of failed negotiations and subsequent exercise of
government use.
Since the government use authorisation ended in November 2005, the MOH
has been considering two options: to negotiate prices of patented products to
an acceptable level or to apply for a renewal of the authorisation.
It appears that the compulsory licensing option will not be used for the lime
being and the advantage gained from the government use order will be used
instead for negotiating lower prices of the patented drugs. However, the limits
to price negotiations and voluntary licensing as experienced in other develop
ing countries (including Malaysia) point to the need for developing countries to
use compulsory licences, including government use, to ensure access to afford
able medicines.
As the issue of access to affordable ARVs gains momentum, the community of
people living with HIV/AIDs in Malaysia has also begun to organise them
selves to promote their rights. In late 2005, the Positive Malaysian Treatment
Access and Advocacy Group (MTAAG+) was officially registered. This is a
group of People Living with HIV/AIDS doing treatment literacy, treatment ad
vocacy and networking.
Bilateral Free Trade Agreements
A recent development that is creating increasing concern is the negotiation of a
bilateral free trade agreement (FTA) between Malaysia and the United States
that was officially launched on 8 March 2006.
FTAs between the US and developing countries as well as Australia contain a
chapter on intellectual property rights that expand the rights and protection for
patent holders by extending patent protection periods, restricting the grounds
for compulsory licensing and prevention of the use of clinical test data for ge
neric drug registration. All these provisions have a negative impact on generic
drug manufacture and access to affordable medicines. This has evoked serious
concerns from many national health authorities and the WHO. For example, the
African Union’s ministers of trade in June 2005 and ministers of health in Oc
18
tober 2005 have issued declarations that call for the rejection of intellectual
property provisions in FTAs that compromise the rights and flexibilities of WTO
Members to ensure access to medicines and public health.6 In January 2006,
when intellectual property rights was the subject of negotiations between Thai
land and the US, there were widespread protests in Thailand, with access to
affordable medicines being a central issue of the protests.
On 3 March 2006 an open letter to the Malaysian Prime Minister was sent by
MTAAG+ and Positive Living, PT Foundation (a program of a community
based organisation that provides a drop-in centre, outreach and peer counseling
for People Living with H1V/AIDS). They have expressed their concerns over
the possible inclusion of intellectual property rights provisions that will threaten
access to affordable medicines and public health and sought assurance that the
Malaysian Government will ‘safeguard our human right to affordable medi
cines and treatment'. (See Appendix 3).
With reference to the government use authorisation, the signatories stated: ‘We
were very encouraged when the Government issued a special compulsory li
cence in 2003 to import some generic ARVs from India for use by MOH. The
monthly treatment cost by government hospitals and clinics fell by 81% from
USD315 to USD58. MOH has targeted 4,000 people to be on ARVs therapy.
But this is still below the more than 10,000 AIDS cases that need urgent treat
ment. The import licence has also come to an end. So we hope and trust that the
Government has plans to ensure continuing access to affordable ARVs. With
out ARVs, more PLWHAs will die.’
Government Use in Indonesia
The second Asian country in the post-Doha Declaration period to issue a gov
ernment use authorisation was Indonesia. This was on 5 October 2004 when a
6
The African Union in an inter-government organisation comprising all Afrcian countries
except for Morocco.
19
Presidential Decree was issued in accordance with Article 5 of the Indonesian
Government Regulation No. 27 of 2004 regarding the Mechanism of Patent
Exploitation by the Government. This was in light of‘the urgent need of com
munity in the effort to control H1V/AIDS epidemic'.
The Presidential Decree No 83 of 2004 Regarding Exploitation of Patent by the
Government on Antiretroviral Drugs empowered the Minister of Health to ap
point a ‘pharmaceutical factory’ as the patent exploiter on behalf of the Gov
ernment, taking into account the recommendations from the Head of the Na
tional Drug and Food Authority. The two ARVs are Nevirapine (for seven years)
and Lamivudine (for eight years).
The Decree also set the ‘compensation fee’ at 0.5% of the net selling value of
the ARVs concerned to the patent holder: see Appendix 4. Production of the
ARVs is underway.
Conclusion
The Malaysian experience illustrates that when health officials and ministers
are informed of the rights and flexibilities under TRIPS, and national patent
laws are designed appropriately, access to affordable drugs can become a real
ity. This is despite the pressures from the patent holders and even misgivings
from other government agencies.
The challenge is to continue to exercise these rights and flexibilities to ensure
access to treatment for HIV/AIDS, as well as to take these rights to treat other
diseases of importance to developing countries.
20
Appendix 1
FORM 11, PATENTS ACT 1983 (MALAYSIA)
APPLICATION FOR COMPULSORY LICENCE
(PATENTS REGULATIONS 1996 - REGULATION 38)
Patents Form No 11
For Official Use
PATENTS ACT 1983
APPLICATION NO :
Filing Date :
Application received on :
Fee received on :
APPLICATION FOR
COMPULSORY LICENCE
(REGULATION 38)
Amount:
To : The Registrar of Patents
Patent Registration Office
Kuala Lumpur
Malaysia
Please submit one copy of this Form
together with the prescribed fee.
1.
* Cheque/Postal Ordcr/Money Order/Draft/Cash
No :
Date of mailing :
Applicant’s or Agent’s file reference
IN THE MATTER OF:
Patent Application No:
II.
Filing Date:
APPLICANT:
Name
:
Address:
Address for service in Malaysia:
Nationality:
* Permanent residence or principal place of business:
Telephone Number
Fax Number
(if any)
(if any)
III.
REQUEST
The above applicant applies to the Registrar to transmit to the Board the request, in
respect of the patent identified above, for the grant of a compulsory licence under section 49
and/or 49A of the Patents Act 1983. in accordance with the terms proposed in Part IV of this
Form and upon the grounds set out in Part V of this Form.
PROPOSED TERMS:
A Statement setting out the amount of royalty, the conditions of the exploita tion of the
patent and the restriction of the rights of the licensor or licensee, as the case may be, is
attached.
IV.
V.
** STATEMENT OF GROUNDS attached.
VI.
ADDITIONAL INFORMATION
The following items accompany this Form:
(a)
(b)
( c)
VII.
evidence that the patent owner has received a request from
the applicant to obtain a licence contract but that he has been
unable to obtain such a licence on reasonable terms and
within a reasonable time
plan according to which the applicant intends to work the
patented invention, including evidence that he has the ability
to do so in Malaysia
other (specify)
SIGNATURE
***(Applicant/Agent)
(Date)
If Agent, indicate Agent’s Registration No:
*
Delete whichever does not apply
** The ground upon which the request is based shall be indicated by a reference to the
statutory provision the applicant considers applicable (section 49( l)(a) and/or 49(1 )(Z>) and/
or 49A of the Patents Act 1983) and to the facts he considers as justifying the grant of a
compulsory licence.
*** Type name under signature and delete whichever does not apply.
Note: This form is for use in the case of an application for a compulsory licence, after
failure to obtain a voluntary licence through negotiations with the patent-holder con
cerned. However, for the purposes of a “Government Use” authorisation, there is no
need for prior negotiations or a prescribed form, and a decision by the relevant gov
ernment authority is sufficient.
22
Appendix 2
GOVERNMENT USE AUTHORISATION
TRANSLATED FROM THE ORIGINAL COPY
29 October 2003
Director of Operations
Syarikat Megah Pharma & Vaccines (M) Sdn Bhd
Suite E 1103, Block E
Pusat Dagangan Phileo Damansara 1
46350 Petaling Jaya
Sir,
Authorisation for exploitation of patented invention in Malaysia
By virtue of Section 84(1 )(a), Patents Act 1983, Syarikat Megah Pharma & Vaccines (M)
Sdn Bhd (Company No : 552048-H) is hereby authorized to exploit patented inventions for
the following drugs :
i.
ii.
iii.
iv.
Didanosine lOOmg tablets produced by Bristol-Myers Squibb;
Didanosine 25mg tablets produced by Bristol-Myers Squibb;
Zidovudine lOOmg capsules produced by GlaxoSmithKline; and
Lamivudine 150mg + Zidovudine 300mg tablet produced by GlaxoSmithKline.
2.
The authorization is valid for two years, commencing November 1, 2003.
It is subject to the following conditions :
i.
the authorization shall be limited to the importation of the above listed drugs from
Cipla, India;
ii.
the drugs to be imported shall only be supply to government (public) hospitals;
iii.
importation of the said drugs shall be subject to the terms and conditions as specific
by the Ministry of Health, Malaysia;
iv.
the quantity to be imported shall be as specified by the Ministry of Health, Malaysia;
v.
all packaging of the drugs shall be labeled with the words "KEMENTERIAN
KESIHATAN MALAYSIA” (Ministry of Health, Malaysia);
vi.
the name (brand), shape or colouring of the tablets or capsules shall be differentiated
from that of the patented products in Malaysia;
23
vii.
the company shall be required to register the sale in the scheduled poisons register;
viii.
The ceiling price for the said drags to be supplied to the Ministry of Health, Malaysia
shall not exceed the following :
(a)
Didanosine lOOmg tablet
- RM74.58 (per box of 60 tablets)
(b)
Didanosine 25mg tablet
- RM22.80 (per box of 60 tablets)
(c)
Zidovudine lOOmg capsules
- RM5.89 (one set of 10 capsules)
(d)
Lamivudine !50mg +
Zidovudine 300mg tablet
- RM 153.50 (per box of 60 tablets)
ix.
Payment of compensation shall be made to the patent holder(s) within 2 months of
each import of the said drugs. The rate of compensation is to be determined at a later
date.
3.
The above terms and conditions may be amended or varied as deemed appropriate.
4. The authorization may be terminated at any time in the event ofnon-compliance with the
terms and conditions as specific above.
(signature)
(TAN SRI DATO’ MUHYIDDIN BIN HJ MOHD YASSIN)
(Minister of Domestic Trade and Consumer Affairs. Malaysia)
24
Appendix 3
OPEN LETTER TO PRIME MINISTER DATUK SERI ABDULLAH
AHMAD BADAWI
3 March, 2006
[Note: Malaysia began formal negotiations on a bilateral free trade agreement with the
United States on 8 March, 2006.]
Appeal for Malaysians to have access to affordable medicines
We understand that the Malaysian Government is about to begin negotiations with the USA
for a free trade agreement (FTA). As a group representing people living with HIV/AIDS
(PLWHAs) in our country, we are very concerned that the life-saving medicines we need
may become even more unaffordable if a FTA is signed with the USA.
Excessive, high prices of antiretroviral drugs (ARVs) due to patents in the hands of some big
global drug companies have led to world wide outcry in recent years. When there was com
petition from generic ARVs used to treat AIDS, the prices of patented drugs fell from
US$11,000 per patient per year to US$150 per patient per year. Even then, this is too
expensive for those who are poor and in deed of treatment. That is why generic drugs are so
very important.
No generic drugs means no access to affordable life-saving AIDS drugs. This will translate
to more deaths to PLWHAs. In Malaysia, figures in June 2005 show that there are 63,438
reported cases of HIV infection, and 10,044 AIDS cases in Malaysia. Between 1986 and
June 2005, we have already lost 7,673 lives.
At the same time, we understand that the Ministry of Health (MOH) is looking at reaching
out to 1,200 intravenous drug users as a target for their Harm Reduction program. With this
program, MOH is also establishing a strong referrals system to hospitals, rehabilitation cen
tres, substitution therapy, etc. This program is an entry' point towards encouraging more
voluntary testing and counseling. Therefore, there are more likely cases of HIV/AIDs to be
detected amongst this invisible population. This in turn will lead to a bigger number of
detected HIV/AIDS cases in Malaysia. The impact of the FTA will also be on this invisible
population. The World Health Organization in June 2005 has already warned that an HIV
epidemic is knocking on Malaysia’s door.
We were very encouraged when the Government issued a special compulsory licence in
2003 to import some generic ARVs from India for use by MOH. The monthly treatment cost
by government hospitals and clinics fell by 81% from US$315 to US$58. MOH has targetted
4,000 people to be on ARVs therapy. But this is still below the more than 10,000 AIDS cases
that need urgent treatment. The import licence has also come to an end. So we hope and trust
that the Government has plans to ensure continuing access to affordable ARVs. Without
ARVs, more PLWHAs will die.
25
That is why we are very' worried about news reports on FTA negotiations with the USA. We
do not know what is being proposed in the Malaysia-US FTA. but based on previous US
FTAs and the US proposals in the controversial Thai-US FTA negotiations, there are a
number of common provisions which are very alarming. We believe the US will demand that
Malaysia also agree to similar provisions, and these will make all medicines more expen
sive.
For example, US FTAs usually force more medicines to be patented and the patents have to
continue for more than 20 years, which is the length of time for patents to run. When a
medicine is patented, it means there is a monopoly and so no other manufacturers can make
that medicine. That means that the patent owner can charge as much as it likes because there
is no competition.
We have learnt that US FTAs also impose monopolies for at least five years even when there
is no patent, by blocking the use of test information by health authorities to register generic
versions of the patented drugs.
We make a strong plea to Datuk Seri and the whole Malaysian Government to reassure us
that public health will always be a top priority and that FTAs with Malaysia will not contain
anything that goes against access to affordable medicines. We urge Datuk Seri to hold con
sultations so that we, the PLWHAs, and all Malaysians can leam more about FTAs that will
be negotiated and how they will have an impact on public health and access to affordable
medicines. We also urge Datuk Seri to continue with the Government’s promise of transpar
ency by making public suggestions and proposals in the FTAs.
For PLWHAs. the treatment that we need is a life long treatment. For us, it is a matter of life
and death. So we strongly appeal to you, Datuk Seri, to safeguard our human right to afford
able medicines and treatment. Please do not allow an FTA with the USA or any country that
will harm the health of Malaysians.
Thank you.
1) Positive Malaysian Treatment Access & Advocacy Group (MTAAG+)
[A group of People Living with HIV/A1DS doing treatment literacy, treatment
advocacy and networking.]
2) Positive Living, PT Foundation.
[A program of Community-Based Organization to provide a drop-in center,
outreach and peer counseling for People Living with H1V/A1DS.]
26
Appendix 4
DECREE OF THE PRESIDENT OF THE REPUBLIC OF INDONESIA
NUMBER 23 YEAR 2004
REGARDING
EXPLOITATION OF PATENT BY THE GOVERNMENT ON
ANTI RETROVIRAL DRUGS
THE PRESIDENT OF THE REPUBLIC OF INDONESIA
Considering: a.
that in line with the urgent need in the effort to control HIV/
AIDS epidemic in Indonesia, it is necessary to provide access to
Anti Retroviral Drugs that are still protected under Patent;
that as exploitation of Article 5 of Government Regulation No
27 of 2004 regarding the Mechanism of Patent Exploitation by
the Government, it is necessary to stipulate a Presidential
Decree regarding Patent Exploitation of Anti Retroviral Drugs
by the Government;
In view of:
Article 4 paragraph (1) of the Constitution of 1945 as amended
by the Fourth Amendment of the Constitution of 1945;
Law No 23 of 1992 regarding Health (State Gazette of 1992
No 100, Supplementary State Gazette No 3495);
Law No 14 of 2001 regarding Patent (State Gazette of 2001 No
109, Supplementary State Gazette No 4130);
Government Regulation No 27 of 2004 regarding Patent Exploi
tation Mechanism by the Government (State Gazette of2004 No
106, Supplementary State Gazette No 4423);
1.
2.
3.
4.
DECIDES:
Stipulating:
DECREE OF THE PRESIDENT REGARDING PATENT EXPLOITATION
OF ANTI RETROVIRAL DRUGS BY THE GOVERNMENT.
First:
The exploitation of patent of Antiretroviral Drugs by the Government is meant
to comply the urgent need of community in the effort to control HIV/AIDS
epidemic.
Secondly:
The type, name of Patent Holder, Patent number and period of Patent exploi
tation of the Antiretroviral Drugs as referred to the First Dictum is attached
in the Annex of this Decree.
27
Thirdly:
Minister of Health may appoint a Pharmaceutical Factory as the Patent ex
ploiter for and on behalf of the Government to exploit the Patent by taking
into account the recommendations from Head of National Drug and Food
Control Authority
Fourth:
The Government shall give a 0.5% compensation fee of the net selling value
of Anti Retroviral Drugs to the Patent Holder.
Fifth:
This Decree shall take effect on the date of its enactment.
Enacted in Jakarta
On 5 October 2004
THE PRESIDENT OF REPUBLIC OF INDONESIA
Signed
MEGAWATI SOEKARNOPUTRI
For true copy
Deputy Cabinet Secretary
Legal and Legislation Department,
Lambock V Nahatlands
28
Annex
PRESIDENTIAL DECREE OF REPUBLIC OF INDONESIA
NUMBER:
83 YEAR 2004
DATED
5 OCTOBER 2004
:
TYPE, NAME OF PATENT HOLDER, PATENT NUMBER, AND PERIOD OF PATENT
EXPLOITATION OF ANTI RETROVIRAL DRUGS
NO
TYPE
NAME OF PATENT
HOLDER
PATENT
NUMBER
PERIOD OF
PATENT
EXPLOITATION
1
Nevirapine
Boehringer Ingelheim (BI)
ID 0001338
7 years
2
Lamivudine
Biochem Pharma INC
ID 0002473
8 years
THE PRESIDENT OF REPUBLIC OF INDONESIA
Signed
MEGAWATI SOEKARNOPUTRI
For true copy
Deputy Cabinet Secretary
Legal and Legislation Department,
Lambock V Nahattands
29
Titles in the TWN Intellectual Property Rights Series
1
Rethinking IPRs and the TRIPS Agreement
by Martin Khor (24 pages $6.00)
2
TRIPS, Drugs and Public Health: Issues & Proposals
by TWN (32 pages $6.00)
3
IPRs and Economic Development - Historical Lessons & Emerging
Issues
by Ha-Joon Chang (40 pages $6.00)
4
Patents and Development: Leassons Learnt from the Economic History of
Switzerland
by Richard Gerster (32 pages $6.00)
5
Biodiversity, Traditional Knowledge and Rights of Indigenous Peoples
by Victoria Tauli-Corpuz (48 pages $6.00)
6
Compulsory Licensing: Models for State Practices in Developing Countries,
Access to Medicine and Compliance with the WTO TRIPS Accord
by James Love (32 pages $6.00)
7
Intellectual Property, Competition and Development
by Martin Khor (44 pages $6.00)
8
Imports by and Exports to Countries with Insufficient or No Manufacturing
Capacities in the Pharmaceutical Sector: Measures Required by the WTO
Decision of 30 August 2003 in Relation to the TRIPS Agreement and Public
Health
by TWN (40 pages $6.00)
9
Malaysia’s Experience in Increasing Access to Antiretroviral Drugs:
Exercising the ‘Government Use’ Option
by Chee Yoke Ling (32 pages $6.00)
MALAYSIA’S EXPERIENCE IN INCREASING ACCESS TO
ANTIRETROVIRAL DRUGS: EXERCISING THE ‘GOVERNMENT
USE’ OPTION
•
An HIV epidemic is knocking on Malaysia’s door.
•
The prices of some antiretroviral (ARV) drugs have become increasingly
high.
•
About 75% of HIV positive persons in Malaysia are intravenous drug us
ers who largely cannot afford treatment.
In a direct and determined response to the above scenario, the Ministry of Health
(MOH) in Malaysia initiated an experience that may be useful for other devel
oping countries.
It resulted in Malaysia becoming the first country to issue a compulsory licence
following the adoption of the Doha Declaration on TRIPS and Public Health by
the 2001 Ministerial Conference of the World Trade Organisation (WTO).
TWN took an active part in this process by providing information to relevant
government agencies regarding developments related to access to affordable
medicines, intellectual property rights and the WTO TRIPS Agreement.
CHEE YOKE LING is a Legal Advisor to TWN. Ofparticular concern in her
work is the ecological, social and economic impact ofglobalisation, especially
in the developing countries of the South.
TWN INTELLECTUAL PROPERTY RIGHTS SERIES
is a series of papers published by the Third World Network to provide
a critical analysis of intellectual property rights protection from a Third
World perspective. A particular focus is given to the WTO Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS) and its
implications for developing countries.
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