Agreement to produce generic against Covid in Brazil should not reach the population

In another year of a pandemic, the world today breathes relieved to have effective weapons available to fight the coronavirus, such as vaccines and the first antiviral pills.

However, experts argue that the inequality in the global distribution of these drugs, as seen for vaccines, should continue to harm low-income countries without access to these drugs, while rich countries have sufficient stocks to treat their populations.

Pfizer announced in March the 35 companies licensed to produce a generic version of its Covid drug, Paxlovid. The agreement, via the Medicine Patent Pool (MPP) mechanism — a tool supported by the World Health Organization for the production of generics in low- and middle-income countries — was signed by the pharmaceutical company itself with the aim of helping to supply the drug to countries considered priorities, which concentrate 53% of the world’s population.

The pill, which works by blocking the replication of the virus in cells, had its effectiveness proven in clinical studies with an 89% reduction in the risk of hospitalization and is now available in several countries, including the United States.

Among the companies chosen to produce the generic is a Brazilian company, Nortec Química, but the production will be restricted to exports, with no plans to sell to the domestic market. Anvisa approved the emergency use of the pill on the 30th.

The license is for the production of nirmatrelvir only, one of the two antivirals present in the formulation. The other, ritonavir, also used to treat HIV, will be produced elsewhere, says the company’s president, Marcelo Mansur.

“As Nortec works only with the IFA [ingrediente farmacêutico ativo]we are going to supply this product to other program licensees who will finalize the drug”, he said. The businessman did not say what the IFA sale price should be for exports due to the confidentiality of the agreement.

“It is an unfortunate situation because once again Brazil falls into the trap of a middle-income country, that is, it is not able to receive the drug via MPP and we will produce it, but we will not be able to sell it to the domestic market or Latin America”, says Elize Massard, a professor at Fundação Getulio Vargas.

For her, the supply of the drug here is restricted to a purchase decision by the federal government, at the price set by Pfizer, and so far the country has not demonstrated the ability to make a market reserve.

Pfizer told the sheet that the details on the availability of the drug in Brazil are in the process of being defined and that it does not comment on contracts or negotiations with the Brazilian government. Its production capacity, he says, is between 80 and 120 million doses of Paxlovid this year. The company says it is “committed to working towards equitable access to oral care”.

Regarding licensing, Pfizer did not answer why the Paxlovid produced here will not be sold in Brazil. In a note, it also said that it “continues to evaluate internal and external options in terms of production capacity, expansion of its manufacturing units, among other possibilities, but that, so far, there are no agreements for technology transfer signed”.

Specialists consider that the MPP mechanism ends up being very comfortable for the pharmaceutical companies themselves, since they choose the licensees, but there is no release of patents to generate autonomy in the development of products.

“In addition to the delay in the process, Pfizer itself chooses who will produce and to whom it will sell, so again there is a concentration of income that is incompatible with a pandemic”, evaluates Pedro Villardi, doctor in health and member of the GTPI (Group of Work on Intellectual Property).

According to him, often the criteria for choosing the potential beneficiaries of the program are marketing, not public health.

Even countries eligible to receive Paxlovid via MPP should only receive it in the last two months of 2022 or early 2023, predicts Villardi. “And Pfizer’s production for this year is paltry. It is again leaving the monopoly for the manufacture of medicines in the hands of a multinational in the midst of a health emergency”, she says.

In the case of vaccines, the WHO’s global distribution mechanism, the Covax Facility, has so far failed to achieve its goal of vaccinating 70% of the population, and the breach of patents has not facilitated access either.

The same view is shared by economist Monica De Bolle, a professor at John Hopkins University and a master’s student in the immunology program at Georgetown University. For her, the argument of the pharmaceutical companies of loss of profit with the breach of patents is a “tacit blackmail” made to the governments to maintain the monopoly of the market.

“It is not true that governments cannot compensate companies for any loss of profit. And they allow themselves to be carried away by this line of argument because the sale of large quantities of medicines or vaccines is also reversed in revenue for the countries of origin of these companies. , in these cases the United States, mainly, but also European countries”, he says.

One way to “force” the breach of patents is the License Law (14,200/2021), sanctioned in August by the Brazilian Senate, but which is still awaiting a vote in Congress after President Jair Bolsonaro (PL) vetoed important items of it, including the mechanism called “compulsory licensing”.

“Brazil could be a world example in this matter. Historically, our pharmaceutical park was relevant in the production of generic drugs against HIV through reverse engineering, and this could happen again for Covid”, explains Villardi.

In a note, the Ministry of Health said that every request for incorporation of treatments in the SUS follows the standard rite of Conitec (National Commission for the Incorporation of New Technologies), of initial evaluation, public consultation and final evaluation. The folder did not respond to whether the government is interested in acquiring doses of Paxlovid or molnupiravir.

Fiocruz, through Farmanguinhos, said it is in advanced talks with MSD to define a model of technical cooperation to evaluate the antiviral against Covid molnupiravir and other drugs in the fight against other viral infections, such as dengue and chikungunya.