[Ip-health] A Conversation with Eloan Pinheiro

[Manon Ress]

http://www.kestudies.org/ojs/index.php/kes/article/view/39/66

Knowledge Ecology Studies, Vol 2 (2008)
Cite as: =93A Conversation with Eloan Pinheiro,=94 KEStudies Vol. 2 (2008).

A Conversation with Eloan Pinheiro

July 2008

Dr. Eloan Pinheiro has played an important role in expanding access to
treatments for AIDS. After beginning her career as a research chemist
for a multinational pharmaceutical company, she later became the
Executive Director of Fundac=E3o Oswaldo Cruz/Farmanguinhos, in Rio de
Janeiro, Brazil. Dr. Pinheiro was chiefly responsible for the
development and manufacturing of inexpensive generic versions of AIDS
medicines in Brazil. After her retirement from Farmanguinhos, Dr.
Pinheiro worked for the World Health Organization on the scale-up of
AIDS treatment in developing countries. In May 2008, Dr. Pinheiro
spoke with the editors of KES.

KES: Dr. Pinheiro, when did you first become interested in the
manufacture of medicines for the treatment of AIDS?

Dr. Pinheiro: In 1996, a Brazilian Presidential decree established the
principle of governmental responsibility for providing all HIV=96
infected citizens with medication essential  to the combat of the AIDS
epidemic, without taking money from the citizens' pockets. This fact,
along with increasing pressure from a pool of non-governmental
organizations, pushed the Ministry of Health (MoH) and the National
Program of DST/AIDS (STDs and AIDS) to request from Farmanguinhos the
production of all ARVs off of patent. The other reason was that the
MoH, unduly burdened by the high cost of imported medicines,
strengthened its proposition to Farmanguinhos: analyzing brand-name
drugs and developing their generic forms.

As director of Farmanguinhos, I accepted the challenge because the
mission and vision of Farmanguinhos was focused on its social role.
Since then, I have believed that the price of any drug cannot
determine whether one lives or dies.

KES: For those who don't know, what is Farmanguinhos?

Dr. Pinheiro: Farmanguinhos is a Technical Institute Unit of the
Oswald Cruz Foundation (Fiocruz), which is responsible for the
production and development of essential medicines.  Fiocruz is a
public foundation directly linked to the Ministry of Health.
Consequently, Farmanguinhos is the government=92s official laboratory.
Its main role is supplying medicines to the strategic programs of the
Ministry of Health and providing safe medicines to the Brazilian
population free of charge.

KES: In 1996, Brazil had not yet granted product patents on AIDS
drugs.  But what were the other challenges in developing generic
versions of AIDS drugs?

Dr. Pinheiro: Our patent law was implemented in May 1996, but the main
reason for developing generic drugs, in my view, was that the majority
of people from developing countries have to live with low salaries or
even without any income.  In such circumstances, purchasing medicines
is a luxury, and if the government does not have an efficient public
health system, many people die without treatment. To confront this
problem, governments have to establish policies on research and
development, policies to incentivize industrialization, legal
procedures to permit the accelerated approval of generic drugs, and
programs to make universal access to medicines and treatment possible.

In Brazil, such policies were implemented, and comprised: (i)
governmental purchasing associated with price negotiation, (ii) a
generic drug-manufacturing policy for non-patented medicines, and
(iii) the introduction of a referential pricing rule for medicines
(maximum price paid by the government for specific medicines).
Farmanguinhos, as the public laboratory of the MoH, successfully
executed its role.

These measures have strongly contributed to the reduction of prices
for medicines in Brazil. The reduction of medicine prices was obtained
not only for anti-retrovirals (ARVs), but also for other medicines on
the market. The Brazilian Generics Law entered into force in February
1999 (Brazilian Generics Law, No. 9,787/99).

In addition, the generic medicines-manufacturing policy contributed to
local capacity building, increased market competition, and
strengthened Brazilian technical competence aimed at acquiring the
know-how to produce Active Pharmaceutical Substances and ARV
formulations.

These were some provisions which were implemented in order to execute
a strategy with the goals of ensuring access to medicines in
developing countries and strengthening local production and development.

It is because of this increase in generic production that bigger price
reductions for ARVs are possible now (see Figures 1 and 2 ).

KES: Brazil issued its first compulsory license on an AIDS drug in
2007.  Until then, Brazil had not made or imported any generic AIDS
drugs that were invented and patented after 1996, the year Brazil
extended product patents to pharmaceutical drugs.  Why did Brazil stop
using generic AIDS drugs for so long, and why was there so much
caution in using the compulsory license mechanism?

Dr. Pinheiro: When Brazil signed the TRIPS agreement in 1994, we knew
that it would bring a lot of problems, firstly, because Brazil
exports shoes, citrus fruits, soybeans, etc., to the U.S., and, in
addition, these economic sectors have strong representatives in the
Brazil Congress to defend their interests. Secondly, the
implementation of the TRIPS flexibility, which was permitted by the
Doha Declaration (2001), has been proved neither easy nor automatic in
developing countries due to the political and economic pressures and
retaliations from developed countries, particularly from the USA.
Moreover, the lack of clear procedures for requesting and managing
compulsory licenses brings uncertainty as to how active pharmaceutical
ingredients can be purchased on the international market at an
affordable price.

 From 1996 until 2000 the National Program provided HAART with off-
patent drugs. The unique exception was the drugs nelfinavir, which was
purchased from Roche. In this case, the Brazilian government tried
hard to decrease the price, negotiating with the owner. To strengthen
their position in the negotiation with Roche, even, the MoH requested
that Farmanguinhos develop, on a pilot scale, the 250 mg dosage of
nelfinavir and the 200 mg efavirenz, importing a small amount from
Indian Companies producers of generic versions.

That strategy elicited a strong reaction. Indeed, the USA threatened
Brazil using its =93Special 301 Report=94, threatening to impose trade
sanctions against Brazilian exportation of items such as orange juice,
shoes, soybean and others. Obviously, the USA gained Brazilian allies
in the export sector.

Despite the government's attempt to issue a compulsory license, the
measure was not accomplished because of the above-mentioned economic
pressures. Notwithstanding, the MoH has gotten a significant price
reduction on those drugs.

Nowadays, the question is the high price of  new, patented drugs which
come to the market every year. Indeed, the Brazilian government has to
both maintain a sustainable AIDS program and deal with patented
medicines, despite their high prices.

Currently, the MoH and the Ministry of Science and Technology give
financial support for the development of innovative drugs derived from
both older and newer drugs, regardless of their patent status.

This action definitely will improve the national capability to quickly
respond whenever a compulsory license is needed.

KES: You eventually left Farmanguinhos to join the staff of the World
Health Organization (WHO) in Geneva.  What were you doing at the WHO,
and what is your opinion of the work of the WHO regarding AIDS and
access to medicine?

Dr. Pinheiro: In July 2004, I was invited to work at the WHO to
organize, within the Department of HIV/AIDS, the Clearing House, which
had as objectives the collection, consolidation and dissemination of
strategic information regarding affordability, accessibility and
availability of HIV drugs. The main tasks I was in charge of were
compiling data on the market prices of medicines and  Active
Pharmaceutical Ingredients (API), as well as identifying their
producers. I was responsible for collecting data about the status of
medicines on the market, including registration, prequalification and
patent status. My other duty was to analyze the actual infrastructure
in low- and middle-income countries, aiming to build in local
production for medicines. My expertise in formulation and
pharmaceutical production notwithstanding, I could unfortunately never
accomplish such a very important task to help people living with AIDS,
in Africa, Asia, wherever.

The objective of my work was to bring transparency to the ARVs market,
helping the MoH and its partners in their advocacy to increase access
to those drugs.

In my view, the WHO is an important organization, which is recognized
worldwide and it is necessary to drive policies more actively.
Unfortunately, there are sectors in the WHO that are very conservative
and that don=92t believe in building local capacity in developing
countries for the production of medicines. On the other hand, I
realize that the WHO suffers from the significant influence of members
who contribute more money to support the WHO infrastructure. This fact
tilts the balance of power in favor of developed countries,
strengthening their proposals. The actions and strategies of
developing countries carry less weight. Consequently, developing
countries and least-developed countries, which comprise the majority
of WHO Member States, face additional difficulties in attending to
their poor population in need of medicines.

I couldn=92t organize a patent database to provide information to these
countries because the most important target for the WHO was to
establish the differential pricing policy for ARVs medicines. Indeed,
in my opinion, to solve the access problems surrounding these
medicines, it is essential to improve local production capability in
order to produce them  within quality standards. However, to achieve
this goal, it is necessary to truly focus on it.

The aforementioned factors are transforming the WHO into a
bureaucratic organization and, consequently, the WHO is making much
less progress in favor of the worldwide poor population. In other
words, the WHO could do much more to benefit poor people by seeking a
balanced position between their members.

 From my viewpoint, the spotlight on the status of a patent is a very
important issue, because this tool provides means to the governmental
and private industry institutions to take decisions on drug production
and procurement.

I believe that the mission of the WHO should be to do everything
necessary to decrease the inequities in health between countries.




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Manon Ress
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