Intellectual
Property Protection for the Pharmaceuticals: An Economic and Legal Impacts
Study with special reference toBangladesh and Mali
Mohammad
Monirul Azam and Yacouba Sabere Mounkoro
1. Introduction
Before the
creation of the World Trade Organization (WTO) in 1995, individual countries
were free to have their own patents laws. But the policy environment has now changed. One
of the WTO agreements, the Agreement on Trade Related Aspects of Intellectual
Property Rights (TRIPS)[1],binding on all
member countries of WTO, basically aims at establishing strong minimum
standards for intellectual property rights (IPRs). Apart from patents,
intellectual property includes copyrights, trademarks, geographical
indications, industrial designs, integrated circuits and trade secrets. Under
TRIPS, all the WTO member countries will have to provide product patent
protection in all products including pharmaceuticals, within the time
specified.
All the
agreements of WTO, including TRIPS, came into force on 1 January, 1995. But
Article 65.2 of TRIPS permits developing countries, a transition period of five
years to implement the provisions of TRIPS. In addition, if a country did not
provide product patent protection in any field when TRIPS came into force, then
under Article 65.4, she gets another five years (in addition to the five years
permissible under Article 65.2) to introduce such protection. But
Articles 70.8 and 70.9 of TRIPS put a limitation on the transition periods
allowed under Articles 65 for two classes of products - pharmaceuticals and
agricultural chemicals. The protection of the rights of the patentees, however
is not the sole concern of TRIPS. TRIPS provides flexibilities for governments
to fine tune the protection granted in order to meet social and economic goals.
Article 7
of TRIPS on Objectives speaks of the mutual advantage of both
producers and users of technological knowledge and stresses the need for a
balance of rights and obligations. TRIPS recognises in Article 7 that the
protection and enforcement of IPRs should be “conducive to social and economic
welfare.” Again Article 8 on Principles, empowers the member
countries to adopt measures to “protect public health and nutrition, and to
promote the public interest in sectors of vital importance …” and “to prevent
the abuse of intellectual property rights by right holders.” Such measures are
however required to be consistent with the provisions of TRIPS. The Preamble to
the agreement recognises that IPRs are private rights. But it also recognises
the underlying public policy objectives and the special needs of the developing
countries to have flexibility in implementing the provisions of TRIPS. In the
light of certain developments and apprehensions expressed, the Ministerial Conference
at Doha adopted a special declaration on issues related to TRIPS and
public health in November 2001. The Doha Declaration clarified and confirmed
that member countries have the rights under TRIPS to take appropriate measures
to protect public health.
In this
paper, we will try to shed light on the status and impacts of the
pharmaceutical patents in the selected least developed countries(i.e., Bangladeshand Mali)
after the introduction of the WTO TRIPS agreement.
2. Objectives
and Scope of the Study
The basic
objective of this paper is to examine the suitability of patent protection for
the pharmaceuticals in the context of the TRIPS agreement. In the second
section we will deal with the issues of argument and counter argument regarding
pharmaceutical patents. In the third section we will show the status of
pharmaceutical patents in the Least Developed countries(LDC’s). In the fourth
section we will evaluate the impacts of pharmaceutical patents both from the
perspectives of patent laws and pharmaceutical sectors in Bangladesh and Mali.
In the next section we will try to find out balancing factors between the
pharmaceutical patent and the right to health under the spaces available under
the TRIPS agreement and outside the TRIPS agreement.
3. Méthodologies
Due to
shortage of time and space, this study mostly based on the secondary data,
available online and paper sources and a few interviews conducted by the both
researchers.
II
4.
Argument and counter argument regarding intellectual property protection on
Pharmaceuticals
This
section explores the grounds on which patent rights are needed for the
pharmaceutical industry and the reasons for which such a right is opposed. The
following two questions, though in rhetorical language, give a perspective to
the issue and highlight the paradox. ‘What if your doctor told you that you are
suffering from a life threatening disease but he may not provide you proper
treatment because the necessary drug costs ten times more than your monthly
salary? What if you were told to go home to die, because no-one is doing
research and making medicine for that disease because you and many others who
are suffering from this disease may not pay enough for the medicine? The
relationship between patent rights and right to health is remarkable because if
patents increase prices of the drugs, at the same time, they provide the
pharmaceutical industry an incentive to innovation to undertake research for
new diseases and develop new medicines.
4.1. Justification
of the intellectual property protection for the pharmaceutical industry:
Of the
various justifications for intellectual property rights utilitarian rationale,
even with inherent problems, is most widely accepted. This is certainly true in
case of patent rights for pharmaceuticals. Even though patent rights
result in patentee’s monopoly over the concerned product in the market; in
economic parlance they are a source of ‘deadweight losses’[2] and
ordinarily, public policy is hostile to monopoly; the justification for
tolerating patents is that they provide a desirable return to inventors. By
virtue of patents, a patent holder is allowed to recoup research and
development costs from the monopoly rents. Thus, the objective is to encourage
an investor to incur the cost of innovation by an assurance that his invention
would not be copied and sold by competitors immediately, driving down the
prices to the marginal cost of producing the product.
There exits
an important relationship between a strong patent regime and research and
development (R&D) in the pharmaceutical industry. The industry spends a lot
on R&D and it views the nature of intellectual property protection as one
of the key elements before investing in research and development. The high
importance that pharmaceutical industry places on patents has been demonstrated
by several studies. Professor Mansfield of the University of Pennsylvania described
dependence of pharmaceutical innovation and development on strong patent
protection. From a survey of the research directors of 100 American
corporations he concluded that in absence of patent, without some period of
restricted competition, the developers of new drugs would be unable to recoup
R&D and regulatory approval costs, and the incentive to develop new drugs
would diminish greatly[3]. It can also
be argued that a strong patent system not only stimulates innovation but also a
consequent generic competition. If new products do not enter into market the
generic industry, which competes on the new commodity, would find it difficult
to flourish.
Patent
system allows easy availability of information. Without such a system, the
spread of information about new discoveries to other firms would be hampered.
Patents allow the information to be used as an input into the new research and
development and thus, others can build upon it and avoid the replication of research
efforts. This area of research and development also differs from most others in
that large numbers of inventions will never make it to the market. The
regulatory approval costs also form a large part of the industry’s total
production cost. Normally it is after a decade that the pre-clinical and
clinical testing phases are completed. R&D and regulatory approval costs
are incurred in the main by the company that develops a drug
initially—subsequent producers of the same drug face much lower costs. Reverse
engineering of pharmaceutical products is considerably easier than for other
products. Furthermore, the probability of success for generic drugs is very
high.
Moreover,
patent rights are also seen as a tool for development in countries because of increase
in technology base from funding, local research and the introduction of
technology that produces economic growth. Countries with strong patent
protection have strong innovative pharmaceutical industry. Some developing
countries that are experiencing strong economic growth and which have adopted
more effective patent protection in recent years have been witnessing increased
drug R&D[4]. For example, Korea is
becoming a technology exporter and most of the new patent applications are from
local companies.
In
contrast, it is said, a weak patent system, or a system that does not protect
the patent at all, will have a chilling effect on local scientific and
technological capabilities. Thus, the evidence unambiguously indicates the
significance of intellectual property rights as incentives for innovation.
4.2.
Opposition to pharmaceutical patents:
It is
generally recognised that patent protection of pharmaceuticals is imperative in
creating incentives for the industry, but there are limitations to this system.
The system is designed to encourage the availability of new drugs in the future
at the cost of restricting the current availability and use. If looked from an
economic perspective the main problem with the patent system is that of
calibration.“Patent systems traditionally provide a fixed term of patent,
regardless of the type of invention or the costs of innovation that need to be
recouped.”The modern patent systems provide a crude way for rewarding inventors
in the face of great uncertainty about the optimal rewards in each case.
Arguments
against patent protection of pharmaceuticals typically centre on social
considerations such as avoiding price increase in health care. Though a variety
of factors, such as rational selection and use of drugs; the costs of drug
testing and approval; sustainable financing; reliable health and supply system;
level of import duties and taxes; and local market approval costs; influence the
price of drugs, patent protection does play a role in determining the
affordability of drugs. There is sufficient evidence to suggest that the effect
of patents on affordability of drugs is significant with drug prices falling
sharply when generic substitutes enter a market to compete with drugs upon
patent expiry.
Though one
can argue that the low income level of the consumers and lack of good medical
insurance cover could also influence in lowering the prices of the drugs, the
evidence does not support such a proposition. There are valid reasons to doubt
if a patent system promotes research in inventing of drugs for diseases more
prevalent in the developing countries or more generally tropical diseases.
Intellectual property rights are limited commercial rights, essentially
economic reward and that the objective of promoting respect for human rights
would at best appear to be a secondary consideration[5]. Pharmaceutical
research is driven by commercial considerations and if the effective demand in
terms of market size is small it is not good commercial sense to invest even in
common diseases like TB and malaria[6]. Moreover,
companies are accountable to their shareholders and therefore, the needs of the
poor in the developing countries, cannot be the guiding motive for undertaking
research.
III
5.
Pharmaceutical Patents and LDC's
Under
Article 66 of the TRIPS Agreement, least developed countries are allowed to
defer implementing the TRIPS Agreement until at least 1 January 2006. The
Ministerial meeting in Doha provided a further 10 year transition period in
respect of introducing patents for pharmaceutical products and protecting
undisclosed information submitted to a regulatory body to approve such products
which is until January 1, 2016 . However, except pharmaceutical patents, all
other provisions of the TRIPS agreement is to be implemented by July 1, 2013.
It is however noted that the requirement to provide patent protection for
pharmaceutical products has already been met by the vast majority of LDC in
Africa and Asia. For example, among the African LDC’s Benin, Burkina Faso,Senegal, Sudan, Tanzania, Zambia, Malawi, Mali respectively
allowed protection for pharmaceutical patents. Among the asian LDC’s Bangladesh
provided patent protection for pharmaceuticals until recent decelaration by the
Government prohibiting pharmaceutical patents.
It is
interesting to explore that whether LDC'c are protecting pharmaceutical patents
due to their ignorance of waiver by Doha declaration or pressure of
transnational Pharmaceutical companies or they are doing this as per obligation
of any bilateral or regional agreement having TRIPS plus provisions.
IV
6. Legal
and Economic Impacts study in selected countries
6.1. Bangladesh
Bangladesh is
a least developed country situated in South Asia. As a least developed
country, Bangladesh is exempted from implementing the general provisions of the
TRIPS agreement until 2013, and has an extension until 2016 to implement its
provisions on pharmaceutical patents (in accordance with the Doha Declaration).
However, the country is presently working towards gradual compliance with the
TRIPS Agreement pursuant to a bilateral treaty with the EU that requires Bangladesh to
amend its national IP regime to conform to the TRIPS Agreement. The
EU-Bangladesh Commission is currently negotiating the U.S-Bangladesh Bilateral
Investment Treaty where the definition of investment includes the protection of
intellectual property. Article 1(c) of the agreement defines investment to
include intellectual property protection.6 Bangladesh’s
Parliament is expected to amend the country’s trademark, patent, and copyright
legislations, following a lengthy inter-agency approval and clearance process,
in order to make the country’s IP regime TRIPS-compliant.
As part of
these obligations, the Law Commission of Bangladesh has formulated a new Trade
Marks Law that makes Bangladesh TRIPS-compliant, in consultation with
the WIPO, has already promulgated as the Trademark Ordinance, 2008[7].
Similarly,
new legislations for Patents and Designs (provisionally called the Patent Law
2007, and the Designs Law, 2007) have been formulated by the Ministry of
Industries, which are presently with the Ministry of Law and Parliamentary
Affairs for legal vetting, and are expected to be enacted next year.
The Draft
Patent Law of 2007 grants an exemption to the pharmaceutical sector, and
provides that “It shall come into force at once except the provisions relating
to examination, sealing, grant and post-grant matters of the patents relating
to pharmaceutical and agricultural chemical products, but excluding the grant
of exclusive marketing rights therefore and mailbox filings which shall come
into force on and from the first day of January, 2016” (Section 1).
In below we tried to evaluate the existing patent regime and pharmaceutical
industry in Bangladesh:
6.1.1. Status
of patent protection in Bangladesh
The present
patent protection regime comprises the Patents and Designs Act of 1911 (last
amended in 2003) and the Patent and Design Rules of 1933. The Act deems patents
to be valid for a total of sixteen years (Section 14), calculated from the date
of application (Section 7), and allows a further extension of ten years
(Section 15(a)(1)). Section 8 contains provisions for opposition to grant of
patent (within four months from the date of advertisement of acceptance of
application). The law grants both process and product patents on
pharmaceuticals.
In fact
until recently as per patent law of Bangladesh pharmaceutical patent
is allowed although Bangladesh is not bound to do so until January 1, 2016 as
per Doha declaration on the Public Health and TRIPS Agreement. In below we
provided a statistics regarding granting of patent in Bangladesh which includes
a good number of pharmaceutical patents.
Patents
Granted in Bangladesh between 2001 and 2007
Year
|
Applications Filed
|
Applications Accepted
|
||||||||||
Local
|
Foreign
|
Total
|
Local
|
Foreign
|
Total
|
|
||||||
2001
|
56
|
239
|
295
|
21
|
185
|
206
|
||||||
2002
|
43
|
246
|
289
|
24
|
233
|
257
|
||||||
2003
|
58
|
260
|
318
|
16
|
206
|
222
|
||||||
2004
|
48
|
268
|
316
|
28
|
202
|
230
|
||||||
2005
|
50
|
294
|
344
|
21
|
161
|
182
|
||||||
2006
2007
|
23
10
|
287
225
|
310
325
|
16
no info
|
146
no info
|
162
no info
|
||||||
However, Non
Governmental organisations, public health group, local pharmaceutical
industries and civil society groups criticised the provision to grant
pharmaceutical patents as detrimental to the public interest and local thriving
pharmaceutical industries. Finally, on the basis of public
demand and evaluating public interest and interest of local pharmaceutical
industries, by a Gazette notification, the government has suspended the
issuance of new patent rights of medicines and agricultural chemicals, as the
country is exempted from issuing patent registrations until 2016 under a WTO
deal[8]. A circular
issued by the Department of Patent, Design and Trademarks in January said as per
the TRIPS agreement all applications for patents of medicines and agricultural
chemicals will be kept suspended until January 01, 2016.It said the previous
applications as well as fresh applications relating to patents for medicines
and agricultural chemicals will be preserved in a 'mail box' and will be
considered after the expiry of the deadline. But once again, the decision has
sparked a debate between local and foreign pharmaceutical companies. The
government took the decision in the light of the agreement on Trade-Related
Aspects of Intellectual Property Rights.
Local pharmaceutical companies that usually produce generic drugs welcomed the decision while the multinationals see it as a barrier to the development of the industry in Bangladesh.The government decision will help local medicine industry, Bangladesh Association of Pharmaceuticals Industries General Secretary Nazmul Hasan said after the notification. He also claimed that earlier patent protection for pharmaceuticals increases products prices.
Local pharmaceutical companies that usually produce generic drugs welcomed the decision while the multinationals see it as a barrier to the development of the industry in Bangladesh.The government decision will help local medicine industry, Bangladesh Association of Pharmaceuticals Industries General Secretary Nazmul Hasan said after the notification. He also claimed that earlier patent protection for pharmaceuticals increases products prices.
On the
other hand Ashfaque ur Rahman, managing director of Novartis
(Bangladesh) Limited(Switzerland based pharmaceutical company), said,
“Bangladesh will be benefited in terms strength of the sector if patent
registration continues. Other countries will evaluate the situation that Bangladesh has
a strong base of patent regime and its products carry specific standards."
Patenting of any pharmaceutical process is a must to maintain product
standards, Rahman added. Another executive of a multinational company said Bangladesh will
not get any new formula because of the suspension. Although in last few years a
number of multinational pharmaceutical companies got their drugs patented in Bangladesh,
now they will not be able to patent their formula in Bangladesh due
to the present notification in line with the waiver given to the LDCs under the
WTO agreement.
6.1.2.
Status of the pharmaceutical sector in Bangladesh[9]
As
mentioned earlier, despite WTO waiver of pharmaceutical patents, it was allowed
in Bangladesh until recently although local pharmaceutical companies
always pushed the government to implement the WTO waiver. On the other hand
there are some foreign pharmaceutical companies in Bangladesh who are
interested to take patent of their products not satisfied with recent move of
the government.
Bangladesh now
exports a wide range of pharmaceutical products (therapeutic class and dosage
forms) to 67 countries[10].
The Drug Control Ordinance of 1982 placed a ceiling on selling imported drugs
in the local market promoted self-reliance in its pharmaceutical sector, prior
to which the local manufacturing catered to only 20 per cent of the total
needs. Local exports have risen from USD 0.04 million in 1985 to USD 27.54 million
in 2006 (Export Promotion Bureau). As opposed to relying on foreign companies
for 75 per cent of their drug supply prior to the Ordinance, local firms now
cater to 82 per cent of the markets, whereas subsidiaries of MNCs supply 13 per
cent of the market and 5 per cent of the drugs are imported. Square
Pharmaceuticals is the largest firm in the market for many years now, and is
followed closely by Beximco, Incepta, ACME and Eskayef (IMS, 2006). Other firms
in the top ten bracket include Aristopharma, General, Healthcare Pharma,
Novartis and Drug International (Ibid.). The market is extremely concentrated:
the top ten firms cater to about 70 per cent of the market and only two
companies, Beximco and Square hold 25 per cent of the entire market.
Pharmaceutical
manufacturing consists of two steps: production of active pharmaceutical
ingredients (APIs), which requires chemical synthesis skills and is commonly
referred to as ‘reverse-engineering’ capabilities, and final formulations,
which is a manufacturing activity and involves the mixing of active
pharmaceutical ingredients with other non-active ingredients into pill,
tablets, or other forms of administration. Pharmaceutical firms in Bangladesh are
mainly engaged in formulation of APIs requiring manufacturing skills only, and
are presently struggling to build capacity in the more knowledge-intensive
processes of reverse engineering active pharmaceutical ingredients (APIs).
Product
range:
Approximately 450 generic drugs, in 5,300 registered brands having 8,300 different
presentations of dosage forms and strengths are manufactured by 237 registered
companies (including 5 multinationals) in the sector. The local companies
produce a wide range of products that include antiulcerants, flouroquinolones,
antirheumatic non-steroid drugs, non-narcotic analgesics, antihistamines, and
oral antidiabetic drugs. I is worth noting that many of the bigger firms are
now venturing into the production of anti-cancer drugs, anti retroviral drugs
for the treatment of HIV/AIDS[11] and
anti Bird Flu drugs.
Firm
size: The
companies include specialized multinational companies, local large companies
with international links and smaller local companies. Out of the 237 registered
companies, only around 150 are estimated to be in a functional state.14The
Bangladesh Association of Pharmaceutical Industries (BAPI) is the main
professional association for the sector, and has 150 member companies that
lobby the government for policy changes, among other activities.
Technologies
used: Firms
mainly use process development technologies to manufacture generic
formulations. The survey shows that the firms import between 75 to 100 per cent
of their machinery and 50 to 100 per cent of all production inputs are imported
from foreign sources.
Despite
very impressive growth over the years, now the pharmaceutical sector
inBangladesh suffers from a lack of coherent policy regime. The Drug
Control Ordinance of 1982 of Bangladesh is almost similar
to India’s policy initiative of a similar kind that triggered
self-reliance in its pharmaceutical sector, but likeIndia, in Bangladesh this
policy has not been supported by complementary industrial policy measures to
support the sector. Even if the new notification under
the patent law that incorporates the Doha flexibilities for pharmaceutical
patents inBangladesh until 2016 is enacted, strategic policy support is
required to promote API and reverse engineering skills amongst local firms, in
order to utilise the flexibilities of the TRIPS agreement and effectively
supply low cost generic versions of patented drugs to other LDCs.
The pharmaceutical
sector falls under the Ministry of Health and Family Welfare (MHFW) in
Bangladesh, rather than the Ministry of Industry and Commerce (or Ministry of
Science and Technology), which is generally the case in other countries. The
sector has not been a leading sector in the most recent economic policies that
seek to provide a variety of incentives for exports, although the government
has enacted a New Drug Policy (2005) and a National Biotechnology Policy
(2005), and is in the process of establishing an API park. The New Drug Policy
(2005) contains provisions for technology transfer and some other incentives to
MNCs to set up production facilities in the country both on a joint venture or
independent basis, although it is not clear how this alone will help in the
absence of other institutional incentives that promote knowledge intensive
activities, such as human skills. The Directorate of Drug Administration is the
key department in charge of the sector, and is supported by the Institute ofPublic
Health, which has the mandate of supporting public health activities, quality
control, and production of biomedicals, training and research. Both
organizations are severely under-equipped and under-funded. One
of the few services offered by the Directorate is the Bangladesh National
Formulary, produced by the Directorate of Drugs Administration which contains a
list of all drugs available in the country, with manufacturing details and
price.
From the
above analysis, we can sum up following propositions on the pharmaceutical
patents and allied issues in Bangladesh
a. Bangladesh allowed
pharmaceutical patents until January, 2008. Now it is suspended pharmaceutical
patents until January 1, 2016 as per WTO waiver.
b. Local
pharmaceutical companies are providing cheap generic medicines and exporting to
a good number of countries, which ultimately contributing for global access to
affordable medicines. But they have to invest in R&D considering future
competitive environment post 2016 scenario.
c. Foreign
pharmaceutical companies not welcomed the decision of the Government regarding
suspension of pharmaceutical patents and consider it may be a barrier for the
technology transfer and investment in the pharmaceutical sector in Bangladesh.
d. Although
cheap medicine is available overall health sector inBangladesh is in very
poor shape due to lack of proper infrastructure and supervision. Therefore
simply non granting of pharmaceutical patent is not enough to ensure right to
health.
e. It
is apprehended that post 2016 Bangladesh may face serious problem due
to high price of patented medicine. But till date Government is not taking
proper steps for capacity building apart from suspending pharmaceutical patent
until 2016.
f. The
Government should encourage local pharmaceutical companies, Universities and
Research institutions to invest in R&D and to come up with local solutions
for common diseases inBangladesh. As foreign pharmaceutical companies may not
be interested for producing medicine of common diseases inBangladesh considering
unprofitable, local institutions have to come up with solutions and innovative
medicines.
6.2. The
Context of Mali
As an LDC, Mali is
allowed to suspend pharmaceutical patents. But as a member of The industrial
property regime of the African Intellectual Property Organization (OAPI), Mali provide
protection for pharmaceutical patents. Mali ratified the 1999
revision of the Bangui Agreement on 19 June 2000. The government ofMali is
also working to harmonize its intellectual property regime with the
requirements of the TRIPS Agreement. The State lacks both human and
financial resources to utilise the TRIPS agreement in general and its flexibilities
in particular.Mali has made 2 direct deposits of patent applications by
non-residents in 2005 and none has been issued therefore not in force[12].
6.2.1.
Status of patent protection in Mali
Patent
protection in Mali is governed by the Bangui Agreement of 2 March
1977 and its Annex 1. The meaning of it:
« "Can
be a patent or a patent confers on its author under conditions and for a time,
the exclusive right to exploit the new invention involves an inventive step and
capable of 'Industrial application. "
The
applicant for a patent must file its application or submit to the Director
General of OAPI which is represented in Mali by Organisation OMAPI.
The
invention is then subject to a formal review of its purpose and compliance of
the claims, a substantive examination to establish that the invention does not
duplicate already granted a patent protected earlier, it is new and involves an
inventive step. The granting of patents held by decision of the Director
General of OAPI and must give rise to a specification. The patent generates for
the recipient an exclusive right to operate for a period of ten calendar years
renewable
Legal
framework in countries OAPI
The
framework of patents in Annex 1 of the Bangui Agreement of 1999 is one kind of
"TRIPS plus" provisions obliterating the moratorium for LDCs as
allowed by the Doha declaration on the TRIPS agreement and Public
Health. There is a lack of clarity of the options, the inability to use the
flexibilities, the difficulties of combating unfair competitive practices and
abuse of IP rights.
6.2.2.
Status of the pharmaceutical sector in Mali
This
development is characterized by four important periods.
Period 1960 - 1983:
Period 1960 - 1983:
The state
has provided most of the functions of the pharmaceutical sector, namely: the
importation and distribution through the People's Pharmacy Mali (PPM), a
company of State, the importation and distribution to public health facilities
through the supply of Pharmacy (Pharmappro) and 2 private pharmacies, creation
of the Malian Office of Pharmacy (OMP) combining administrative functions of
distribution, production and research, the strengths of this period are the
existence of import and distribution, the care and medicines are free, and its
weaknesses were lack of private sector, decline of resources for the purchase
of medicines, mismanagement of state structures.
Period 1983 - 1989
Period 1983 - 1989
The
characteristics of this period can be summarized as the elimination of
Pharmappro, the creation of the Malian plant pharmaceuticals, a monopoly of the
MPC on the importation and distribution of drugs, the experience import
essential drugs in DCI in the first development project to promote health cost
recovery MOE and the viability of systems tested. There are other many
important factors listed under: the development of real laboratory for
experimenting with the distribution of drugs (Federations of habitations (FGR),
Zones expansion and literacy CO rural areas, health stores in the regions of
Timbuktu, Gao and Mopti, the privatization of health professions has resulted
in the development of private pharmaceutical sector, the development and
implementation of the reform pharmaceutical, remove the OMP.
Period 1989
to January 1994 considering that Mali became member of WTO
in 11th January 1993:
The
fundamental characteristics of this period are: Putting into practice the
concepts of the Bamako Initiative in the distribution of medicines and cost
recovery, the lifting of the monopoly of popular pharmacy which resulted in the
emergence of drug wholesalers of 4 private, the Health Project population and
rural water supply among others contributing to the acceleration of the
establishment of community deposits at health facilities, the establishment of
new experiences drug distribution in Segou (Draft Segou SSP), in Sikasso (draft
PSMs / PSF) and Koulikoro (PAPDK) and others, the signing of a contract between
the state plan and the Popular Pharmacy of Mali, making it the preferred tool
in the supply of essential drugs, the reorientation of different experiences
drug distribution areas north (Gao, Timbuktu), remove the Inspectorate of
Health.
Period from 12 January 1994 to present
To
anticipate the effects of devaluation, the Department of Health has taken the
following measures: Freezing of consumer prices from 13 to 31 January 1994,
following negotiations between the various stakeholders in the field of
medicine,
limiting the rising price of the drug through a consensual setting new margins which saw the government reduce the tax burden on medicines from 22% to 6%, wholesalers reduce their margin of 20% to 14% and pharmacists of pharmacies by 25% to 20%. These measures have helped to limit the increase to 55%, renewal of the policy of essential generic drugs at both the national level with the redefinition of a new political and subregional level marked by the return of Abidjan (March 1994) and the final communiqué of Brussels (April 1995), establishment of a distribution system called the master supply and distribution, mobilization by the MSPAS its development partners for assistance that enabled the acquisition of Meg, by an open international quality and competitive prices, agreement between distributors and private MSPAS on the establishment of maximum margins on medicines and distribution of essential medicines, fixing the maximum MSPAS margins in public and community training, development of the Code of Public Health.
limiting the rising price of the drug through a consensual setting new margins which saw the government reduce the tax burden on medicines from 22% to 6%, wholesalers reduce their margin of 20% to 14% and pharmacists of pharmacies by 25% to 20%. These measures have helped to limit the increase to 55%, renewal of the policy of essential generic drugs at both the national level with the redefinition of a new political and subregional level marked by the return of Abidjan (March 1994) and the final communiqué of Brussels (April 1995), establishment of a distribution system called the master supply and distribution, mobilization by the MSPAS its development partners for assistance that enabled the acquisition of Meg, by an open international quality and competitive prices, agreement between distributors and private MSPAS on the establishment of maximum margins on medicines and distribution of essential medicines, fixing the maximum MSPAS margins in public and community training, development of the Code of Public Health.
6.2.3.
The national drug policy
Mali, to
achieve the goal of health for all, has established guidelines and clear
strategies through a national policy based on the social cultural and economic
goals of the country. In December 1990, Mali declared its sectoral
health policy and population, based on the principles of IB (Bamako
Initiative), the essential drugs occupied a central place.
Four major
strategies were used in this sector policy and population health. This is the
extension of health coverage and improving the quality, availability and
accessibility of essential medicines, community participation in managing the
system, mobilization of resources needed to finance the system health,
including cost recovery.
Another
major problem in the health sector of Mali is the counterfeiting
medicines. Despite the efforts of governments, the phenomenon of drug known as
"land" persists. A tour through the capital Bamako enough
to realize the magnitude of this trend but it is an even more serious within
the country where the majority of the population is illiterate. Yet the
government has made great efforts to combat the scourge by substantially
lowering drug prices and promoting essential medicines commonly called DCI
(international name). In 2003, prices of DCI had been regulated in the public
sector. Resulting in price reductions ranging from 3 to 64% depending on the
product. On 25 January 2006, the Council of Ministers adopted a decree fixing
the prices of essential medicines in the private sector. The decree sets the
prices of 107 medicines. The result is an overall decrease of about 31.5% of
prices in the private sector.
In Mali,
90% of diseases are treatable with essential medicines, while the only
difference between them and specialties is that the drug has fallen into the
public domain. It is true that conventional medicine pharmacies remain
relatively expensive despite government efforts.
From the
above analysis, we can sum of situation of Mali pertaining to
pharmaceutical patents as follows
a. In Mali till
date pharmaceutical patent is allowed although the country being a LDC is
entitled to waiver of Pharmaceutical patents until January 1, 2016.
b. The
pharmaceutical sector in Mali was completely under the control of
Government as a nationalised industry. But after becoming a member of WTO the
Government tried to attract private investors in this sector. The aims of
withdrawing government intervention were to improve the health and
pharmaceutical sector and to ensure affordable medicine for its citizens.
c. Even
withdrawal of government monopoly on the pharmaceutical sector till date the
progress of pharmaceutical sector in Mali is not satisfactory rather
the price of medicine is increasing day by day.
d. Traditional
knowledge as means of treatment has great prospect in Mali, so government
should take initiative so that it is not exploited unduly by any transnational
pharmaceutical companies.
V
7.
Towards a Balanced Legal Regime for the Pharmaceutical Patents
7.1. Options under the TRIPS Agreement: Flexibilities under TRIPS
It is anticipated that with the introduction of full product patent protection in pharmaceuticals before or after 1st January, 2016, as the generic companies are to be prevented from introducing new drugs, the lack of competition will result in high prices. Supply of low cost new drugs to the local market and to other countries will be threatened.
However, TRIPS provides for some flexibilities to member countries of WTO to take action to tackle such negative consequences of product patent protection. We analyse here to what extent Bangladesh and Mali can utilise them for protecting public interest.
Within the scope of TRIPS, the following are the main flexibilities which developing countries can use:
7.1.1. Provide exemptions from grant of patents in certain cases:
7.1. Options under the TRIPS Agreement: Flexibilities under TRIPS
It is anticipated that with the introduction of full product patent protection in pharmaceuticals before or after 1st January, 2016, as the generic companies are to be prevented from introducing new drugs, the lack of competition will result in high prices. Supply of low cost new drugs to the local market and to other countries will be threatened.
However, TRIPS provides for some flexibilities to member countries of WTO to take action to tackle such negative consequences of product patent protection. We analyse here to what extent Bangladesh and Mali can utilise them for protecting public interest.
Within the scope of TRIPS, the following are the main flexibilities which developing countries can use:
7.1.1. Provide exemptions from grant of patents in certain cases:
Under
Article 27(1) of TRIPS, patents will have to be provided for inventions, which
are “new, involve an inventive step and are capable of industrial application”
The agreement however does not define these terms. This provides some
flexibility. It has been suggested that a developing country can interpret
these terms so as to restrict the number of patents (Correa 2000; Abbott 2001;
CIPR 2002).
Developed
countries, for example, USA follow very liberal patent standards.
Patents are granted not only for new chemical entities (NCEs) involved in the
new drugs. Secondary patents can also be taken for new formulations, new
combinations and new uses of existing NCEs. As a recent research report in USA has
found, most of these new products provide no clinical benefits (NIHCM 2002).
But these secondary patents can be taken later and since these would be valid
even after the expiry of the patents on NCEs, the entry of generics can be
delayed (Federal Trade Commission 2002). WHO (2001) in fact has warned that if
the patentability standards are too broad, so that the terms “new”, “inventive”
are defined to include all the new forms of the same NCE, then effectively the
patent life can be extended beyond the 20-year period. WHO has advised
governments to exercise discretion in this regard. CIPR (2002, p. 49) has
pointed out that there is no compulsion under TRIPS for the developing
countries to follow the liberal patent standards of developed countries. The
aim should be to ensure that patents are granted for true technical
contributions and not for blocking innovation and legitimate competition by
generic producers (Correa 2000, p. 110).
Stricter
patentability criteria are important not only to prevent the MNCs from
“evergreening,” i.e., extending the life of patents. It can also prevent them
from taking action to stop the generic companies from producing drugs covered
by mailbox applications.
The
Goverment of Mali and Bangladesh may take a restricting view of the
definition of invention so as to prevent TNCs from broadening the scope and
duration of their patent. Unfortunately till date the national laws of both
country is very broad so as to allow MNCs overgreening practices.
7.1.2. Provide exceptions to product patent rights in certain cases
Patents
basically confer on the patentee the right to prevent others from using the
invention. But such rights are not absolute. All patent laws usually provide
some qualifications to such exclusive rights. Article 30 of TRIPS permits
member countries to “provide limited exceptions to the exclusive rights
conferred by a patent …” This article does not list the specific acts for which
exceptions can be provided. What it says is that such exceptions should satisfy
certain conditions that it does not “unreasonably conflict with a normal
exploitation of the patent and do not unreasonably prejudice the legitimate
interests of the patent owner, taking account of the legitimate interests of
third parties”. TRIPS does not contain any other explanation about the terms,
“limited exceptions”, “unreasonably conflict”, “legitimate interests” and hence
the use of this provision depends on the interpretation of these conditions.
The following three are the most significant and common exceptions which the
national laws in many countries provided when TRIPS came into effect:
a) Early
working b) Parallel imports and c) Research and experimental use.
It is
generally understood that individual countries have some flexibility in
interpreting these terms and incorporating some exceptions to exclusive rights
of the patentees in national patent laws. But under TRIPS , in the absence of
clear guidance, any such use by a country can be contested by any
other country and in that case the former cannot use it unless the dispute is
resolved in its favour.
a)
Early working(bolar exceptions)
The “early
working” provision is popularly referred to as the “Bolar” provision or
exception, as it is known in USA. It is important to understand the
background of the Bolar provision.
Under the
Bolar provision of the Patent Act, non-patentees could start using the patented
product for regulatory purposes even before the expiration of the patents.Moreover,
generic applicants were no longer required to repeat the clinical studies to
prove the efficacy and the safety of the product. They were permitted to rely
on the innovator company’s safety and efficacy data and could file only anAbbreviated New
Drug Application (ANDA). The generic applicants were required to demonstrate
that the generic drug product has the same active ingredient, route of
administration, dosage form and strength and is bioequivalent (the rate at
which the drug becomes available for absorption in the patient) to the relevant
brand-name product.
The Bolar
provision is very important for generic entry. It permits generic entry soon
after the patents expire and hence allows the consumers to benefit from
competition and lower prices without delay. In the absence of it, generic
companies will have to wait till the patents actually expire before they can
start the tests necessary for getting regulatory approval. During the several
months or even years it may take to get such approvals, the patentee will effectively
enjoy monopoly status even though there are no legal barriers to entry.
The WTO
dispute panel upheld the use of the Bolar exception as conforming with TRIPS in
the Canada-EU dispute. Not surprisingly, after the very clear ruling in the
EC-Canada case, ,most of the countries provides for Bolar exception.
Mali enjoys
the benefits of Bolar exception under Article 8 of the Bangui Agreement of March 2, 1977 (Annex I),
since September 1984, as last amended in February 1999 and adopted in 2002.
Unfortunately in the Patents and Designs Act, 1911 of Bangladesh not
provided any provision for early use like bolar exceptions. Therefore, the
patent law of Bangladesh may be amended to incorporate this.
b) Parallel imports
Under
Article 28 of TRIPS, the patent owner has the exclusive right to prevent others
not only from making, using or selling the invented product or process in the
country, but also importing from other countries. This is however subject to
Article 6 on “exhaustion.” What it basically means is that the patent holder in
a country cannot legally stop imports of patented products offered for sale in
another country. Such imports of patented products without the consent of the
patent holder in the importing country are known as parallel imports. This is
very important in the pharmaceutical industry because the same patented
medicine is often sold at different prices in different countries and hence
parallel imports permit a country to shop around for the lowest price. The
underlying justification of allowing parallel imports is that since the
innovator has been rewarded through the first sale of the product, its patent
rights have been “exhausted” and hence it should have no say over the
subsequent re-sale. Under Article 6 of TRIPS as clarified by the Doha
Declaration (paragraph 5(d)), each country is “free to establish its own regime
for such exhaustion without challenge.”
The patent
law of Mali and Bangladesh yet to introduce a parallel
import provisions.
c)Research
and experimental use
As
the Doha Declaration has affirmed, “the TRIPS Agreement shall be read in the
light of the object and purpose of the Agreement as expressed, in particular,
in its objectives and principles”. Utilising the above deceleration, the LDCs
may provide exceptions for research and experimental use of patented medicines
for the promotion of technological innovation and transfer and dissemination of
technology. This is also important for maintaining and developing efficient
alternatives to protect public health and to prevent patentees from abusing
patent rights (Article 8 onPrinciples). R&D is a continuous process.
If the indigenous sector is asked once in a while to develop a process, it is
possible that they may not be able to do so. The opportunity of using the patented
product for R&D purposes, will enable the indigenous firms to be ready with
efficient processes and use these whenever they are permitted to do so. Article
66.2 obliges the developed countries to provide incentives to developing
countries to promote technology transfer.
This
provision may also be utilised by the Mali and Bangladesh and
all other LDC’s.
7.1.3.
Limit data protection
To
get marketing approval for a new drug developed, innovator companies are
required to submit test and clinical data relating to safety and efficacy to
national health authorities. The current practice is that when generic
companies apply for approval of their drug, they are not required to conduct
their own studies and submit independent data. They can rely on the safety and
efficacy data submitted by the innovator company and get marketing approval for
their products. But if the law of a country provides for data exclusivity,
i.e., grants exclusive rights to the innovator company to prevent subsequent
applicants from using the data submitted, then generic companies cannot use
such data till the data exclusivity period ends.
Article
39.3 of TRIPS is being interpreted by the MNCs and some developed countries,
particularly USA to mean that WTO member countries are required to
grant data exclusivity for a specified period of time. But tracing the
negotiating history and the text of Article 39, Watal (2001) and Correa
(2002(a)) have concluded that the protection need not be in the form of data
exclusivity. Watal 2001 (a) has pointed out that if that were the intention
then the terms “exclusive rights” would have been used as in Article 70.9 (p.
204). Article 39.3 requires countries to protect data against “unfair
commercial use.” And as Correa has argued, countries have the discretion to do
so not through data exclusivity but by proscribing situations where a
competitor obtains the results of testing data through fraud, breach of
confidence or other “dishonest” practices and derive a commercial advantage.
Protection
is not necessary if regulatory authorities do not require the submission of
such data for marketing approval or if the data are already public. Protection
is required only for new chemical entities. Countries have considerable
discretion in defining what is “new,” and may exclude the different
formulations based on the same chemicals. Thus even if test data are required
to justify a new formulation, Article 39.3 does not require any protection of
such data.
Thus if Mali and Bangladesh utilise
the above flexibility that would be useful to promote generic
pharmaceutical industries.
7.1.4.
Provide for government use
Article 31
of TRIPS dealing with compulsory licensing provides for special provisions “in
the case of a national emergency or other circumstances of extreme urgency or
in cases of public non-commercial use.”
Public use
of patents or “government use” is a standard feature of patent laws in many
countries. Under 28 USC Sec 1498 of the US patent law, the US government
can use a patent or authorize third parties to use patents for virtually any
public purpose. For any such use, the government is not required to negotiate
with the patent owner. Nor is the latter provided any injunctive relief. All
that it can expect is payment of compensation for the use.
The government
or anyone authorised by it may use (i.e., “make, use, exercise or vend”) an
invention or acquire an invention for the purpose of the central government,
state Governments or a government undertaking on payment of adequate
remuneration or compensation. Except in circumstances of
national emergencies, extreme urgency or public non-commercial use, the
government need not even inform the patentee about such use. The patent owner,
however can challenge such a use or the terms of such use. If the patented
drugs are too expensive, then the government can produce or authorize others to
produce and distribute these through public clinics.
In Bangladesh,
considering the public interest Government may revoke any patent(under section
25 of the Act) . But this provision is not similar to TRIPS. Therefore, it may
be challenged by any WTO member in future. That is why, the patent law of Bangladesh may
follow the approach of US law. In Mali the provision of
government use is not clear enough.
7.1.5.
Provide compulsory licenses to non-patentees
TRIPS do
not use the term “compulsory license.” Article 31 refers to “use without
authorization of the right holder,” and includes both use by third parties
(what is usually refereed to as compulsory licenses) and use by government.
Article 31
of TRIPS dealing with compulsory licensing, does not place any restriction on the
grounds under which a compulsory licenses can be given. In case there were any
doubt, the Doha Declaration has made it clear that “Each member has the right
to grant compulsory license and the freedom to determine the grounds upon which
such licenses are granted.”
The problem
is that certain conditions listed in the Article will have to be satisfied.
These include: (i) that authorization of such use will have to be considered on
its individual merits, (ii) that before permitting such use (except in such cases
as situations of national emergencies, extreme urgency, public non-commercial
use), the proposed user will have to make efforts over a reasonable period of
time to get a voluntary license on reasonable commercial terms, (iii) that the
legal validity of the compulsory licensing decision and the remuneration will
be subject to judicial or other independent review, (iv) the compulsory
licenses can be terminated if and when the circumstances which led to it cease
to exist and are unlikely to recur.
In fact as
WHO and WTO point out, compulsory licensing is one of the ways in
which TRIPS attempts to strike a balance between promoting access to existing
drugs and promoting R&D into new drugs.
In Bangladesh section
22 of the Act deals with the grant of compulsory licenses and revocation of
patents. According to this section, any person can present a petition to the
government of Bangladesh that the demand for a patented article is
not being met. Under such circumstances, the government or the high court
division may order the patentee to grant licenses on reasonable terms as they
thinks fit. A revocation can also be made within grant of four years of the
patent, in case the patentee fails to give adequate reasons for his default of
non working or lack of adequate supply(Section 22 (4)).
Under the
TRIPS Agreement, Mali allows use by third parties (compulsory
licensing) or use public non-commercial (use by the government) without the
permission of the patent owner. Agreement does not limit the grounds for these
uses, but it contains a number of conditions must be met in order to protect
the legitimate interests of the patentee.
7.2.
Human Rights consistent legal regime for the Pharmaceuticals
Almost 2
billion people lack access to essential medicines. Improving access to existing
medicines could save 10 millions lives each year, 4 millions of them in Africa
and South-East Asia. Access to medicines is characterised by profound
global inequity. 15% of the world’s population consumes over 90% of the world’s
pharmaceuticals. The Millennium Development Goals(MDG), such as reducing child
mortality, improving maternal health, and combating HIV/AIDS, malaria and other
diseases, depend upon improving access to medicines. One of the Millennium
Development Goal targets is to provide, in cooperation with pharmaceutical
companies, access to affordable essential drugs in developing countries. The
Constitution of the World Health Organisation (WHO) affirms that the highest
attainable standard of health is a fundamental right of every human being. The
Universal Declaration of Human Rights lays the foundations for the
international framework for the right to the highest attainable standard of
health. This human right is now codified in numerous national constitutions, as
well as legally binding international human rights treaties, such as the
International Covenant on Economic, Social and Cultural Rights and the
Convention on the Rights of the Child. Medical care and access to
medicines are vital features of the right to the highest attainable standard of
health. In 2000, the United Nations Committee on Economic, Social and Cultural
Rights confirmed that the private business sector has responsibilities
regarding the realisation of the right to the highest attainable standard of
health. While this general statement of principle is important, it provides no
practical guidance to pharmaceutical companies and others. In below,
we tried to provide some idea for balancing pharmaceutical patents
and right to health paradigm:
7.2.1.
Duty of the sate
The state
parties have a duty to respect, protect and ensure human rights. As right to
health is a human right, therefore states are bound to ensure, protect and
respect right to affordable medicines. Thus when patented medicines are out of
reach of its citizens state must go for bargaining, negotiation and/or taking
all the necessary steps to ensure right to health of its citizens. Over the
years, the government of Brazil and south Africa negotiated
and finally resort to compulsory license for ensuring affordable medicine for
its citizens.
7.2.2.
Duty of the Global Actors (WTO, WIPO, UN, WHO etc)
World
Intellectual Property Organisation(WIPO) and WORLD Health Organisation(WHO)
both are specialised agency of the United Nations. Therefore both the
organisation must work together to meet the human rights of all including right
to health which is one of the prime objectives of the United
Nations. Keeping in mind this prime objectives and MDG, WIPO and WHO may go for
negotiations with the WTO to make a framework to investigate the issues how
intellectual property in general and pharmaceutical patent in particular may
become human rights consistent in general and pro public health in particular.
There may be a global agreement integrating all the major global players(WTO,
WIPO, WHO), representative of pharmaceutical companies, stakeholders etc under
the arrangement of United Nations for balancing between pharmaceutical patents
and right to health.
7.2.3.
Duty of the Pharmaceutical Companies
Although
pharmaceutical companies are interested to invest for profitable
medicines(which has great demand in the developed countries) and would like to
charge as much as possible to recoup its investment and maximise profit, there
must be some limit and alternative measures. In this case, there may be
guidelines that all pharmaceutical company must invest 30%-40% of its total
capital for neglected diseases. This may be ensured by a global agreement
between the state parties of the United Nations. Again, there may be creation
of global impact fund which will provide some compensation to any
pharmaceutical company in proportion to its investment, R&D and
contribution for neglected diseases in the developing and least developed
countries.
7.2.4.
Duty of the Civil Society groups
Civil
society and Non Governmental organisation can play a major role to investigate
the problems of public health and related issues. In every country
civil society group and NGO’s may be encouraged to make monthly or yearly
studies on the impact of patent on the health sector of the country and may
propose particular government to take proper measures to ensure public health
and balancing between intellectual property and public health. They may also
make study and database on the available traditional medicinal knowledge in the
country and may encourage the people to use the same.
8. Concluding Remarks
Under
TRIPS, it is mandatory for all member countries of WTO to provide patent
protection for all products including pharmaceuticals. But the protection of
the rights of the patentees is not the sole concern of TRIPS. TRIPS provides
flexibility for governments to strike a balance between the private rights of
patentees and the socio-economic needs and objectives of its people. The costs
of high prices resulting from product patent protection can be tackled by:
(i)
resorting to parallel imports or granting compulsory licenses during the patent
term and
(ii)
ensuring that the entry of generics is not delayed after the expiry of patents.
In a
product patent regime, a proper compulsory licensing system is of vital
importance in promoting competition while ensuring that patentees get
compensation through royalties. In fact compulsory licensing is one of the ways
in which TRIPS attempts to strike a balance between promoting access to
existing drugs and promoting R&D into new drugs.
On the
other hand, until January 1, 2016, all the LDC’s may suspend the protection of
pharmaceutical patents and may take capacity building programs to encourage R&D
and investment in the pharmaceutical sectors and to promote its
research institutions to come up with local solutions for common diseases in
the country. Furthermore, WTO, WIPO, WHO may take measures to make the existing
intellectual property mechanisms human rights consistent and development
friendly not only for developed countries but also for least developed
countries. Let us work together for a better world, where nobody will die
simply for lack of medicine or high price of patented medicine.
[2] Alan O. Sykes, TRIPS,
Pharmaceuticals, Developing Countries, and the Doha“Solution”, 3 Chi. .
Int’l L. 47, 57. According to Sykes, deadweight loss occurs when monopolists
charge more for goods and services than the cost of producing them, thereby
pricing consumers willing to pay that cost but less than the monopoly price out
of the market. This loss of ‘consumer surplus’ represents the standard
deadweight loss. In addition, with patents, monopoly rents may be dissipated by
excessive investment in the race to develop new invention – a so called patent
race. The extent of monopoly power in the form of patents proportionally
decides the amount of deadweight losses.
[3] Edwin Mansfield, ‘Patents and
Innovation: An Empirical Study’, 32 Management Science (1986) 175. According to
another study pharmaceutical R&D expenditure in the UKwould be reduced
by 64% in the absence of patent protection. C.T. Taylor and Z.A. Silberston,
The Economic Impact, The Economic Impact of the Patent System (Cambridge, UK:
Cambridge University Press 1973). Grabowski, supra note 51, 849,
where he cites several such studies. Also see, Scherer, F.M. (2001) “The Patent
System and Innovation in Pharmaceuticals”, Revue Internationale de Droit
Economique, (Special Edition, “Pharmaceutical Patents, Innovations and Public
Health”) 109-112
[4]Singham, supra note 60, at 375-79.
Countries such as Japan and Canada that changed their laws
in favour of strong intellectual property laws have experienced dramatic
increase in R&D investment in their domestic pharmaceutical industry since
making the change. Henry Grabowski, supra note 51, at 854-855.
[6] Report of the High Commissioner on
Human Rights on ‘The impact of the Agreement on Trade-Related Aspects of
Intellectual Property Rights on Human Rights.’ UN Doc No. E/CN.4/Sub.2/2001/13,
27 June 2001, paragraph 38. (Hereinafter Report of the High Commissioner)
[7]See for details, Azam, Mohammad Monirul,
Intellectual Property, WTO and Bangladesh, New Warsi Book Corporation, 2008, Dhaka, Bangladesh..
[9] This
section is based on Gehl Sampath, “Innovation and Health in Developing
Countries: Can Bangladesh’s Pharmaceutical Sector Help Promote Access to
Medicines?” A UNU-MERIT Study, 2007. This is a broader study on the
pharmaceutical sector in Bangladesh, that looks at all other components in
the domestic knowledge system (such as universities, public research
institutes, hospitals and clinics), in addition to firms.
[12] Rapport
de l’OMPI sur les brevets, statistiques sur l’activité-brevets dans le
monde : Organisation Mondiale de la Propriété Intéllectuelle Édition
2007
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