Intellectual Property Group opposes a resolution which would restrict access to medicines in Brazil

Our partner in Brazil highlights the facts in a debate full of confusion.

Last month, the Working Group on Intellectual Property (GTPI) contributed to a public consultation put forward by Anvisa (Brazilian National Health Surveillance Agency).
Anvisa’s proposed Resolution (n. 327/2017 “Import of unregistered products for use in SUS programs”) would restrict the purchasing of medicines through international multilateral organizations, with the only exception being in cases where there is “proven unavailability in the domestic market”.

Our partner ABIA, is a member of GTPI, which believes the resolution, as it stands, would make it difficult for the Brazilian population to access a number of essential medicines. In addition, it would effectively be quietly bringing in a change to legislation, when it does not have the remit to do so.

The facts of the matter

There are many situations where it is beneficial to buy medicines through a multilateral body. To take an example, this would apply where the only registered supplier in the country charges abusive prices. This is often the case in reality, and purchasing through multilateral agencies makes it possible to circumvent this type of assault on the health budget.

With many medicines purchased by the Brazilian health system, there is a monopoly held by a single supplier in the country. A monopoly allows pharmaceutical companies to set prices much higher than what the medicines may be purchased for in the international market. The higher price limits access, since cost is a key criteria in deciding whether, or how much of a drug, to procure. If purchased, only a portion of the patients in need will benefit as budgets don’t stretch to cover everyone.

Advocates for Anvisa’s more restrictive proposal are trying to create confusion by associating lack of national registration with lack of quality, but the truth is that multilateral agencies do apply strict quality criteria. Therefore, this claim is false and seeks only to distort the debate.

If the resolution is approved, or if the Ministry of Health continues to buy reference medicines, when there are quality assured generic options available, the Brazilian government will be establishing an undue monopoly, and paying significantly higher prices for the same technology.

No remit to legislate

Law No. 9.782 / 1999 exists in Brazil to regulate products registration, procurement, and exemption, of products for use in public health programs.

Anvisa’s resolution would therefore effectively be legislating. GTPI believes that a change which would have such a profound impact cannot come from an administrative decision but from a legal change.

GTPI’s contribution to the consultation calls for the cancellation of the paragraphs that restricts purchase through multilateral organizations, in order to preserve a space that can be used by the government to deal with abusive prices and protect the sustainability of free access to medicines in the Brazilian health system.