Details of Module and its Structure

Module Detail

Subject Name Sociology

Paper Name Sociology of Health

Module Name/Title Issues of Accessibility and Affordability to Medicines in India

Pre-requisites

Objectives To understand the issues of accessibility and affordability in India.

To examine the barriers to access to medicines.
To analyse the role of state.
Keywords Patent policies, Pharmaceutical industry, Neglected diseases, availability,
affordability

Structure of Module / Syllabus of a module (Define Topic / Sub-topic of module)

Issues of Accessibility Introduction, Intellectual Property Rights and Issue of Access to Medicines
and Affordability to in India, TRIPS Flexibilities and Access to Patented Medicines, Constraints in
Medicines in India TRIPS Flexibilities, The Paradox of the Indian State, Barriers to access,
Recommendations by Experts, Discussion

Role Name Affiliation

Principal Investigator Prof Sujata Patel Dept. of Sociology,

University of Hyderabad
Paper Coordinator Prof Purendra Prasad Dept. of Sociology
University of Hyderabad
Content Writer/Author (CW) Shilpa Krishna Dept. of Sociology
Research Scholar University of Hyderabad
Content Reviewer (CR) Prof Purendra Prasad Dept. of Sociology
University of Hyderabad
Language Editor (LE) Prof Purendra Prasad Dept. of Sociology
University of Hyderabad
Module 16

Issues of Accessibility and Affordability to Medicines in India

1. Introduction
2. Intellectual Property Rights and Issue of Access to
Medicines in India
2.1 TRIPS Flexibilities and Access to Patented
Medicines
2.2 Constraints in TRIPS Flexibilities
3. The Paradox of the Indian State
4. Barriers to access
5. Recommendations by experts
6. Discussion

1. Introduction

On 24 September 2001 Tsapi Thathe, a young man living with HIV, was shot and killed in
Soweto by people intent on stealing his cell-phone. Tsapi was a volunteer for the AIDS
Counselling and Care Trust (ACCT).He was also an active member of the Treatment Action
Campaign (TAC), involved in campaigns to reduce the price of patented essential medicines,
thereby hoping to postpone his inevitable illness and premature death caused by HIV. In
April 2001 he was briefly imprisoned for participating in an illegal demonstration at the
head office of the Pharmaceutical Manufacturers Association (PMA) in Johannesburg.
Tsapi's death points to the tenuousness of 'health' in Africa and other parts of the 'developing
world'. (Mark Heywood: 2002)

Access to essential medicines is a major determinant of health outcomes. In spite of health

being one of the important agendas for Millennium Development Goals (MDG), the present
situation of health indicators in South East Asia and Sub-Saharan Africa is dreadful and
require attention. Most of the countries in these regions are suffering from double burden of
communicable and non-communicable diseases mainly HIV-AIDS, TB, and Malaria etc. In
developing countries, cholera and tuberculosis - diseases are causing death while in the
developed countries, they have lost their ground. According to the World Health
Organization (WHO), six million children under the age of five die every year due to lack of
medical care. Access to Essential Medicines is a serious problem throughout the world
especially in the developing countries. About one third of the world population lack regular
access to essential drugs, which is as high as 50% in the poorest parts of Africa and Asia.
(Mandall and Mandal: 2013)

Many African countries continue to rely on chloroquine, an outdated drug, to treat malaria
because the newer, more effective artemisinin-based treatment costs as much as twenty times
more. Hepatitis C, a lifelong infectious liver disease causing cirrhosis and liver cancer, affects
170 million people worldwide, but the cost of treating one patient is 30,000 US$ per year.
Governments of poor countries cannot afford such high prices for medicines when running a
health system on very limited resources. High prices also create barriers to research; for
example, the high cost of the new quinolone class of antibiotics has prevented sufficient
research into whether such drugs could be used to reduce the length of tuberculosis treatment,
which currently takes six to eight months (Sinha: 2014). Gehrke (2012), points out that
developing a new drug takes approximately 10 to 12 years and Pharmaceutical companies do
not specify the exact costs; rather they project figures of $600-800 million (462 to 616
million euros) as needed to develop a new pharmaceutical agent. While the US consumer
advocacy organization ‘Public Citizen’ estimates actual costs for the development of a new
drug at a maximum of $110 million. The huge difference stems from the fact that the
companies factor in so-called "opportunity cost": the benefits a company could have had if it
had invested its money in an alternative project. Expensive modern medicine and the
pharmaceutical industry's patent policies are the main reasons for inadequate access to
medicines. In the next section we would discuss about the patent policies and its
consequence in the Indian context.

2. Intellectual Property Rights1 and Issue of Access to Medicines in India:

Bhardwaj (2013) notes that India from 1947 to 1970s was dependent on imports of highly
priced medicines due to the Patents and Designs Act 1911. In 1959, Justice N. Rajagopal
Ayyangar submitted the ‘Report on the revision of the patents law’ to the government. The
report outlined the recommendations for the overhaul of India’s patent regime insisting that
patents on medicines should be restricted to process patents. Based on this recommendation
the Indian government enacted the Indian Patents Act of 1970. This meant that the product
that is the medicine could not be patented and the manufacturers were free to come up with
different processes to manufacture the same medicine. This process was referred as Reverse
engineering. As a result of this act a strong and a vibrant indigenous generic industry was
developed which for several decades was able to provide a safe, effective and affordable
medicines not just to India but also to much of the global south. By 2000 the impact was felt
beyond the Indian borders and India was referred as the pharmacy of the global south.

The Indian generic industry has often been depicted as a ‘copycat’ industry implying that
everything has been copied and there is no innovation involved. It is true that India did not
innovate new drugs (except for a few which were not commercially successful). But India
did innovate new processes for manufacturing drugs. In fact the processes developed by the
Indian generic companies were often superior to those developed by the MNCs. Even after
the product patent expires abroad, a generic company cannot enter the market unless it can
develop a process of manufacturing which does not infringe on any existing patented process.
MNCs usually patent a large number of processes to prevent the entry of generics, and skill is
required to create a new non-infringing process. Eli Lilly, for example protected the
production of cefaclor through 32 processes. Ranbaxy managed to develop a new and
superior process, and paved the way for collaboration between Eli Lilly and Ranbaxy. The
Indian generic industry has earned international recognition for the innovative capability of
developing non-infringing processes. (Chaudhuri: 2007).

An Indian company called Cipla produced HIV-AIDS generic drugs that could treat a patient
for US$300 a year, far cheaper than the branded product’s cost of US$10,000 a patient a year.

1
For details refer Module 17 on ‘Drugs and Patents’.
Today, the Indian drug cost has been cut further to below US$80 (RM248). This has enabled
millions more AIDS patients to be treated. India supplies 70% of the HIV-AIDS drugs
obtained by UNICEF, the Global Fund and Clinton Foundation for developing countries. And
75%-80% of medicines (not only for AIDS) distributed by the International Dispensary
Association to developing countries come from India. Therefore, India has been termed the
pharmacy of the developing world. Khor (2012) explains “For millions of poor and sick
people around the world, the Indian pharmaceutical industry has been something of a life-
saver, thanks to its capacity to produce cheap generic versions of expensive patented drugs.
However, some developments are threatening to undermine India's role as the pharmacy of
the developing world.” The major threat is the intellectual property agreement known as
TRIPS (The Agreement on Trade-Related Aspects of Intellectual Property Rights) which was
established in 1995 along with the World Trade Organisation. It disallowed countries from
excluding medicines from patentability. To implement TRIPS obligations, India passed
changes to its patent law in 2005 so that medicines could be patented.
A Brief Comparison of Indian Patent Act, 1970 and TRIPS, 1995
Different Indian Patent Act, 1970 TRIPS-WTO, 1995
Provisions of
Patent Acts
Type of Patents Only process patent allowed Product patent allowed in all
in the case of sectors
pharmaceuticals,
chemicals and food
Effective Duration Seven years from the date of Twenty years from the date of
of Patent filing or five years from filing of patent application
the date of sealing,
whichever is earlier
Compulsory Compulsory licensing Restrictive use of the provision
Licensing* allowed after three of compulsory licensing –
years of sealing of allowed only when there is
patent if the prices of national emergency/public
product under question non-commercial
is above reasonable use/government use
level or if it did not
satisfy public interests
Working of Domestic production alone is Whether products are
Patent* considered as ‘working manufactured locally or
of patent’ imported, it would amount
to ‘working of patent’
Burden of Proof In case of patent The burden of proof would fall
infringement, the on the alleged defendant
burden of proof lies of patent infringement.
with the complainant
of the patents
Transitional - Developing countries like India
Arrangement are given time period till
31, December 2004.
However, the exclusive
marketing rights for patent
holders would start from
January 2000.

India’s best patent law of 1972 has been eroded because many new drugs since 2005 have
been patented by multinational companies which sell them at exorbitant prices. Indian
companies can no longer make their own generic versions of these new medicines unless they
successfully apply to the government for compulsory licences - which is quite cumbersome -
or unless they obtain a licence from the patent-owning multinational, and that usually comes
with stringent conditions especially for export. According to the International health
organisation UNAIDS and WHO, Report on the Global HIV/Aids epidemic, June 1998,
“India had made remarkable progress in antiretrovirals (ARV) used in the treatment of HIV.
By mid 1990s, effective treatment for HIV in the form of triple combination therapy (that is
three medicines taken at the same time) was known to the world though it was largely
available only in the developed countries.” UNAIDS executive director Michel Sidibe (2012)
says “Millions will die if India cannot produce the new HIV/AIDS medicines in future, it is a
matter of life and death.” India has had positive worldwide impact through its large supplies
of low-cost, good quality generic medicines. Millions of lives have been saved or prolonged
by this. Many people from developing countries would buy life-saving generic medicines
from Indian pharmacies and take them to give to relatives who cannot afford the expensive
original products. Patients worldwide suffering from various ailments have benefited from
cheap generic Indian drugs. (Khor: 2012). However there are certain flexibilities in TRIPS
agreement which has facilitated the industry to succeed.

2.1 TRIPS Flexibilities and Access to Patented Medicines

The TRIPS Agreement contains certain flexibilities that allows countries to determine the
criteria for an invention to grant a patent, and governments to grant a compulsory licence to
local companies to produce the patented products if the latter's requests to patent owners for a
voluntary licence do not succeed (Khor:2012). That is restriction on the patenting of
insignificant or minor improvements of known medicines (under section 3[d]); provision of
compulsory licensing to encourage generic competition and reduce prices (under Article 31
of the TRIPS agreement); pre- and post-grant opposition to patents, etc. By restricting the use
of frivolous patents (which the multinational drug companies have mastered), section 3(d)
disallows pharmaceutical companies from obtaining patents in India that are not actual
‘blockbuster’ inventions, but a slightly modified version of an existing medicine whose
bioequivalence can be easily established. Large drug companies often indulge in patenting
medicines whose utility or efficacy is already known, which are typically designed to delay
generic competition, and result in higher prices. Compulsory license is vital for the Indian
government as it is a powerful tool to combat high drug prices and reduces the procurement
costs considerably. It is also important for people who approach the private sector for
treatment as 80 per cent of all out-patient treatment takes place in the private sector. (Sakthi
and Nabbar, 2010)

A. Section 3 (d) of Indian Patents Act Limitation on Patentability -The mere discovery of a
new form of a known substance, which does not result in the enhancement of the known
efficacy of that substance; Salts, esters, ethers, polymorphs, metabolites, pure form,
particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives
of known substance shall be considered to be the same substance, unless they differ
significantly in properties with regard to efficacy”
Example- Novartis patent application for a CML drug known as Glevic was rejected in 2006.
Grounds of rejection were on many grounds including section 3(d).

B. Compulsory Licensing Indian Patent Act- Compulsory licensing is the authorisation given
by the government, judiciary or even the competition commission to a third party to
produce, market and supply a generic version of a patented drug, without the consent of
the patent holder. Under Article 31 of the TRIPS Agreement, Compulsory Licensing is a
legally recognised means to overcome barriers in accessing affordable medicines.
 Example- Natco Pharma requested for a CL for the anti-cancer drug Nexavar (Sorafenib
Tosylate), patented by Bayer and was granted in March 2012.

2.2 Constraints in TRIPS Flexibilities-

There are many constraints on incorporation of TRIPS flexibilities. There is Pressure on

developing countries not to use TRIPS flexibilities as there is threat of litigation and lack of
IP oriented technical assistance and expertise. There is No mechanism to assess the impact of
patented [Link] Patent Office plays a vital role in the implementation and utilisation
of the TRIPS flexibilities. India incorporated these flexibilities to curb the practice of
patenting of known substances. The Patent Office has to apply these flexibilities while
examining the patent applications and to decide whether the patents are to be granted or not.
Due to the inefficiency of the Patent Office in applying the legal safeguards to prevent the
patenting of known substances, many patents were also granted on molecules invented in
1960, 1970, 1980 and 1990s. Since these molecules are already available in India these
patents may not affect the availability of these medicines in its original molecule form, but
would deny access to the incrementally modified forms of these medicines. Data also reveals
the growing number of patent applications from the pharmaceutical MNCs. Pharmaceutical
MNCs attempted violate the public interest safeguards available in the Patents Act by not
recognising India’s sovereign rights to use the TRIPS flexibilities. MNCs also continue to
lobby against Section 3(d) of Patents Act. There is a consistent campaign against Section 3(d)
stating that it denies benefits of incremental innovation to Indian patients. Pharmaceutical
MNCs try to neutralise the generic industry’s freedom to make use of the pre-grant
opposition by providing voluntary licence containing obligation to protect the patent on
generic companies. (Gopakumar: 2010)

However, the Indian pharmaceutical industry is responding in multiple ways, depending on

their financial strength, to meet the challenges of product patent regime. The generic
industry’s response includes: R&D on new drug development, patent challenges and
innovation on existing drugs. The new drug development strategy is in a nascent stage and is
yet to develop the final product. However, the patent opposition strategy paid good dividends
to Indian companies. It helped them launch many new drugs, which would have otherwise
been patented.

3. The Paradox of the Indian State

With the help of the flexibilities and other industrial policies the Indian‘s pharmaceuticals
industry has boosted the country into being the ‘global pharmacy of the south’, exporting life-
saving drugs to developing countries and supplying quality drugs to the rich nations at
affordable prices. The country now boasts of operating the maximum number of Food and
Drug Administration (FDA) - approved manufacturing facilities outside the United States. In
2013, national production of Drugs and Pharmaceuticals of India was placing the country in
a strong position in the pharmaceutical world, but ironically, 50- 65 percent of the Indian
population have no regular access to Essential Medicines . Only 0.36 percent of the GDP is
allocated for health care budget in India (2010-2011), which is insignificant in comparison to
the actual need. Moreover, it is anticipated, that medicine prices are likely to spiral to a great
extent in the coming years because of current global policies, thereby making the problem of
non-availability of medicines graver day by day. (Mandall and Mandal: 2013)
Indian pharmaceutical industry was valued at $ 12 billion in 2013. The market is primarily
driven by exports to regulated as well as semi-regulated markets. In 2014, India exports drugs
to more than 200 countries and vaccines and biopharmaceutical products to about 151
countries. (Business standard: 2014) India has received worldwide recognition as a low-cost
producer of high-quality drugs and globally, India ranks 3rd in terms of volume and 14th in
terms of value. This has contributed to accessibility of drugs abroad and reflects strong
innovative capabilities developed in India. Yet at home, most Indian people do not have
regular access to essential medicines.

Selvaraj and Nabar (2010) states “Despite the seemingly commendable performance, millions
of Indian households do not have access to drugs as a result of financial (lack of the
necessary purchasing power) or physical barriers (lack of public health facilities). India’s
health and drug policies have, over the years, tended to benefit the wealthy and the private
sector rather than the vulnerable masses.” Sengupta (2013) rightly notes “One of the best
developed pharmaceutical industries is sitting on top of the poorest health care systems” The
contrast between the success of Indian industrial policy in developing the industry and the
failure of Indian health policy in ensuring access to drugs demonstrates starkly the need for
integration of industrial and health policies if safe universal access to essential medicines
is to be achieved (Chaudhri: 2007)

4. Barriers to access:

According to Chaudhri (2007) there are three basic elements that are required for ensuring
access to medicines: Availability, Accessibility and Appropriateness:

A. Availability- Medicines are considered to be available if the medicines required for

the relevant diseases exist, are produced (or can be imported) and distributed and are
of proper quality. Diseases prevalent in the poor countries are often neglected. There
are very few or no drugs exist for the neglected diseases. While diseases like malaria
and TB have drawn attention, there are no drugs for diseases such as African
trypanosomiasis, leishmaniasis and Chagas’ diseases (the ‘most neglected’ diseases).
However, drugs are available for many other diseases which affect the population in
India. Production of these drugs has not been a problem in India. The problem is
distributing the drugs to those who need them and ensuring that these are of proper
quality. Most Indian states do not have a proper drug procurement and distribution
system. As a result drugs are often not available when they are needed.

B. Affordability – The medicines should be available as well as affordable. Purchase of

drugs is financed by the consumers, by the government or through private or other
forms of insurance. Publicly funded healthcare and/or subsidized insurance can both
influence prices and shift the financial burden from the poor who are unable to afford
the cost and thereby improve accessibility.

C. Appropriateness- a medicine must not only be available and affordable, It must also
be appropriate to a particular need. Due to many factors like misleading advertising,
lack of education and information, illiteracy and the lack of effective regulation of
prescribing, medicines sold are often not appropriate. In India thousands of brands are
available in the market. But the vast majority of these are considered to be
therapeutically irrational, resulting in tremendous wasteful expenditure.
 4.1-Other Barriers are:
(a) Unreliable supply system
(b) Irrational prescription
(c) Poor quality medicines
(d) Unaffordable pricing
(e) Inadequate funding for research in neglected diseases
(f) Unfair health financing mechanisms
(g) A stringent product patent regime

Policy options to improve affordability and availability of medicines according to WHO

(2011)

1. Selection of essential medicines

a. Formulation/updating of essential medicines lists and institutional formularies

b. Development and use of Standard Treatment Guidelines
c. Development of a therapeutic substitution policy

2. Procurement/ purchasing

a. Limit to an essential medicines list by international non-proprietary name

b. Base quantities on reliable estimates of actual need
c. Base on formal written procedures and explicit, predetermined criteria to
award contracts (i.e. ensure transparency of the process).
d. Plan properly and monitor performance (results should be made publicly
available)
e. Base on competitive procurement from prequalified suppliers n Pool
procurements at the national level
f. Use pharmaco economics or external reference pricing (international price
comparisons) as a guideline for setting prices of new medicines (single-
source)
g. For high-priced products, apply pressure for differential prices and consider
use of TRIPS a flexibilities for medicines under patent

3. Distribution system

a. Maximize efficiency and transparency

b. Control mark-ups with regressive margins and with effective enforcement

4. Generic competition

a. Establish an effective quality assurance capacity

b. Reduce regulatory barriers to market entry of generic equivalents (e.g. early-
working, fast-tracking applications, reduce the application fee)
c. Permit and promote generic substitution

5. Prescribing and dispensing

a. Introduce incentives to prescribe and dispense generic medicines

 b. Improve health professional and public confidence in generics
c. Provide unbiased consumer medicine information
d. Strictly regulate promotion of products by pharmaceutical companies according to
WHO’s Ethical Criteria for Medicinal Drug Promotion and ban direct-toconsumer
advertising of prescription medicines
e. Separate prescribing and dispensing functions; develop and monitor good prescribing
and good dispensing practices
f. Empower patients through the publishing of prices and availability
g. Establish regular monitoring of prices and availability

6. Financing

a. Encourage pooled and prepaid financing of medicines (e.g. through employment

based or social insurance schemes)
b. Support community-based insurance initiatives that focus on improving access to
essential medicines
c. Establish a social health insurance system covering the whole population
d. Ensure that social health insurance benefits are comprehensive, using limited
formularies based on cost-effective therapeutic guidelines, and that patients are not
required to seek reimbursements
e. Abolish taxes and duties on essential medicines
f. Introduce minimal or no patient co-payments in the public sector or health insurance
systems.

5. Recommendations by experts-

Gopakumar (2010) suggests that Policy concerns on access to affordable medicines demand
changes in:
a) Fine-tuning of the relevant provisions of the Patent Act
b) Sound policy measures
c) Capacity building of institutions like the Patent Office and judiciary.
He also warns that mere incorporation of the TRIPS flexibilities in the domestic legislation
alone is not enough to address the concerns of access to medicines. The flexibilities in
domestic patent law should be complemented with sound policy measures and institutional
support. Such complementary policy measures and institutional support requires investment
in financial and human resources, which most of developing countries cannot afford.

The Planning Commission’s High Level Expert Group (HLEG) report (2011) on Universal
Health Coverage (UHC) for India, in tune with the demands made by the groups such as the
All India Drug Action Network, the Jan Swasthya Abhiyan and the Medico Friend Circle
have recommended (Srinivasan, 2012)
a. Increase public spending on drug procurement to 0.5% of the gross domestic
product and provide free essential medicines to all.
b. Enforce price regulation and apply price control on all formulations in the
Essential Drug List.
c. Ensure drug and vaccine security by strengthening the public sector and protecting
the capacity of Indian private sectorcompanies to produce low cost drugs and
vaccines needed for the country.
d. Strengthen institutional mechanisms for procurement and distribution of allopathic
and AYUSH drugs.
 e. Promote rational use of drugs through prescriber, patient and public education.
f. Strengthen central and state regulatory agencies to effectively perform quality and
price control functions.
g. Protect the safeguards provided by the Indian patents law and the TRIPS
Agreement against the country’s ability to produce essential drugs.
h. Transfer the Department of Pharmaceuticals to the Ministry of Health.

However Srinivasan (2012) who is working with LOCOST (Low Cost Standard therapeutics,
a non-profit organisation) is sceptical, about the government accepting these
recommendations. He expresses concern and hopes that in the interest of public health and
for a reduction of impoverishment due to ill health the government implements the
recommendations along with their comments on the report.

6. Discussion-

From a human rights perspective, implementation of intellectual property rules should be

governed by those principles which support public health goals and access to medicines, thus
ensuring a rapid and effective response to public health needs and crises; supply of quality
medicines at affordable prices; effective competition through a multiplicity of potential
suppliers; the provision for a wide range of pharmaceuticals to meet the basic health needs of
the population; and equality of opportunities for countries in need, irrespective of their
membership in the WTO, level of technological capacity, or lack of manufacturing capacity
(WHO: 2005)

Gherke (2012), observes that there is not only lack of access to inexpensive drugs but also
lack of health infrastructure, such as doctors, logistics, supply, drugstores and diagnoses in
the developing countries along with poor policies. He adds, hunger and malnourishment also
promote diseases, such as diarrhoea, pneumonia and malaria. Therefore a strategy that
involves the government and the drug companies is needed to ensure that the local
pharmaceutical industry continues to thrive, that it produces not only the existing medicines
but also the new medicines even if they are patented, and that they are supplied at affordable
prices not only in India but in the rest of the developing world.

Gopakumar (2010) notes that the introduction of product patent protection in India raises two
critical concerns with regard to access to medicines:
First, whether the grant of product patent would curtail the existing supply of generic drugs?
This concern is emerging due to the mailbox protection under TRIPS. India started accepting
product patent applications from 1995 as per the transitional provisions of TRIPS. During this
period, Indian generic companies introduced many new medicines in the market for which
product patent applications were pending under the mailbox facility. If patents were granted
on these applications, the generic companies would have been exposed to liability of patent
infringement. Further, patent on existing generic medicines also eliminates the generic
availability of that medicine. Section 11 A of the Patents Act addressed these concerns by
allowing the generic producers to continue the production even after the grant of patent
against a royalty payment to the patent holder. However, no patent holder has claimed
royalties under Section 11. Generic companies used pre-grant opposition provisions to
challenge the patent applications on medicines having generic versions.
Second challenge is regarding the availability of patented medicines at an affordable price.
Compulsory licence and government use provisions of the Patent Act is going to play critical
role in ensuring access to patented medicines. However, both these safeguards suffer from
procedural and substantial limitations. Hence, Gopakumar (2010), states that these provisions
do not offer an effective tool to deal with the abuse of patents.

Chaudhri ( 2007), points out that India occupies an important position in the international
pharmaceutical industry, yet fails to give its own population access to essential drugs. The
sense of paradox is armored by evidence that Indian generic companies have made drugs
more accessible for US consumers. These companies have been able to challenge the patents
of the MNCs and speed up the entry of generics in the US, reducing prices. Lofgren (2013)
asserts that the tension between capital accumulation and public health is reflected in
fragmentation and friction within governments. Policies and programs in the three main
regulatory areas of (1). Safety and efficacy controls for the purpose of public health, (2)
Access and equity, and (3). Assisting industry development, are promoted by different
departments and agencies, which are in turn linked to distinct groups of social and economic
interests, including business associations and firms, health professionals and consumers. Such
fragmentations between agencies and interlocking advocacy coalitions are a characteristic of
pharmaceutical policy in all countries, particularly those with significant local industries. If
accessibility of drugs for all is to be ensured, the state needs to play a much more active and
pervasive role. It is too critical a matter to be left to the market and private sector. The state
needs to regulate the manufacturers, to exercise bargaining power to influence prices and to
fund directly or indirectly the health care expenses of those who need care but cannot afford
it.