[Ip-health] Statement by Ambassador Maria Nazareth Farani Azevado of Brazil to WHO Executive Board on Counterfeit medical products

[Thiru Balasubramaniam]

THE FINAL VERSION

"Mr. Chairman,

Madam Director-General,

Members of the Board,

Ladies and gentlemen,

Let me start by saying that falsification of medicines, in Brazil, is
typified as heinous crime. So, this clarifies any question  on the
Brazilian position on the matter.

The Brazilian Government is deeply concerned with the quality, safety
and efficacy of medicines and other medical products. This is
reflected in our national health policy and international action. In
this sense, Brazil has been working to combat the falsification of
medicines and medical products and to hinder all forms of illegality
with a strict focus on the risks to public health.

Based on those assumptions, the Brazilian Government believes that, at
the global level, the World Health Organization is the forum for the
debate of methodologies focused on the quality, safety and efficacy of
medicines and other medical products, taking always into consideration
the protection of public health and the promotion of access to
medicines. WHO should help Member States strengthen their regulatory
capacities and authorities always based on concerns of health
surveillance and regulation.

On the other hand, the Brazilian Government understands that WHO is
not the forum for discussions on enforcement of intellectual property
rights. Other issues related to IP are of interest to WHO and its
Members, and are an integral part of the Global Strategy and Plan of
Action on Public Health, Innovation and Intellectual Property. We also
believe that any norms or definitions set to deal with quality, safety
and efficacy issues have to be inclusive, evidence-based and done
through a member-state-driven process. In that sense, Brazil opposes
the draft resolution on counterfeit medical products. Any definition
related to the falsification of medical products cannot be used to
undermine the access to legitimate generic medicines, especially in
countries where they are part of national public health policies. As
well as on branded medicines, any deviations of quality or non-
compliance to Good Manufacturing Practices are infractions against
public health, but should not be taken as examples of falsification.

As a concrete example of the negative impacts of the relationship
between health issues and the enforcement of IPRs, I would like to
read the following joint statement made by the Minister of Health of
Brazil, Dr. Jose Gomes Tempor=E3o, and the Minister of Foreign Relations
of Brazil, Ambassador Celso Amorim, released today:

The Brazilian Government has learnt, with great concern, of the
retention by the Dutch authorities, in the port of Rotterdam, of a
shipment of the generic drug LOSARTAN, which was produced in India and
being transported to Brazil. The drug was sold by the Indian company
Dr. Reddy's to the Brazilian company EMS, which would distribute it in
the Brazilian market as a medicine for arterial hypertension. In
Brazil, hypertension is one of the principal causes of disease and
death, and the majority of the patients depend on the Unified Health
System (SUS, the universally available, government funded, healthcare
system) for treatment.

The production of LOSARTAN in India is sanctioned under the
international legal instruments which govern intellectual property
rights in the pharmaceutical industry, in particular those which are
stated in the TRIPS Agreement (Trade Related Intellectual Property
Rights). In Brazil, as in India, the drug is not protected by a patent
and may be imported freely, if the shipment is in accordance with the
applicable sanitary legislation. In the Brazilian market, there are
currently numerous generic pharmaceuticals which contain LOSARTAN in
their composition.

The decision to retain the shipment - which was not, at any moment,
brought onto Dutch territory - was undertaken as a result of an
administrative request from a third company (therefore without the
official endorsement of the local judiciary system) which allegedly
owns intellectual property rights over LOSARTAN in the Netherlands.
This process imposes on the supplier, and not on the company which
requested the intervention, the responsibility to prove the legality
of the transaction, essentially an inversion of the universally
accepted juridical concept that the accusatory part must present the
evidence.

Irrespective of the value or volume involved, or of the fact that the
shipment was returned to the country of origin (India), the Brazilian
Government considers that the decision by the Dutch authorities to
detain an input which is strategic to public health in a developing
country, and exported in conformity with the existing international
norms, represents a grave drawback in the treatment of the issue of
the universal access to medicines. It represents a distorted use of
the international intellectual property system, supposedly upheld by
European Union legislation, and contrary to the spirit and provisions
of the "Doha Declaration on TRIPs and Public Health". This is the sort
of procedure that this  Organization  should  oppose  to,  firmly.

The case must also be seen in light of the direction which the
IMPACT  (International Medical Products Anti- Counterfeiting
Taskforce) initiative has taken. Under the pretext of a fight against
counterfeit medicines, this program attempts to impose a revision of
WHO's position on the issue, with a view to inhibit the legitimate
commerce of high  quality, competitively priced generic drugs.

Considering the severity of the case, which is the first to directly
affect Brazilian imports for the public health sector, the Brazilian
Government decided to raise the issue before this Executive Board. Our
delegation wishes to stress, before  the  international  health
community, its dissatisfaction with the action undertaken in the port
of Rotterdam, which raises doubts with respect to the commitment of
European countries to the issue of access to medicines by the
populations of developing countries. Other possible reactions will be
taken into consideration according to how this problem evolves,
including within the World Trade Organization (WTO). Brazil defends
the primacy of health over trade, as the WTO's very regulations
establish, as well as the right of countries to fully use the
flexibilities of the TRIPS Agreement to guarantee universal access to
medicines, as reaffirmed by this Organization in the Global Strategy
on Public Health, Innovation and Intellectual Property.

Thank you."

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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997