Generics in Argentina: a test still to be passed

"The most impressive achievement of our generics policy has been in the area of social inclusion. There are now three million Argentinians who can afford to buy the drugs they are prescribed, which previously were beyond their reach…”

These words of the Health Minister, Dr Ginés González, are supported by his explanation that 57% of prescriptions in Argentina use the generic name of the drug – and backed up with an amazingly positive statistic for access to medication among the most vulnerable sectors of society, to the effect that, “Paracetamol, which is an analgesic and antipirético, costs 85% less than last year…”

With these statements, Gonzáles García is voicing an undeniable truth. But is this the whole truth about generics in our country? The answer is no.

When I take, as a patient, an analgesic and antipirético which costs 85% less than last year, I am grateful to Health Minister Ginés. But as a person living with HIV/AIDS (PLHA), when the Ministry of Health gives me antiretroviral drugs of unproven and unresearched quality, I think that Mr. Ginés is leaving me vulnerable to potentially negative effects this medication may produce in my body in the future.

Beauty is in the eye of the beholder

From a market perspective, it is understandable that the manufacturers of these drugs should use all the means at their disposal to promote the “marvels” of the product they are selling, whether these are generics, patented drugs, or the dreaded imitations. But these “marvels” lose their meaning when those of us taking ARVs suffer from nausea, diarrhoea, vomiting – or don’t, depending on the manufacturing process and the quality control behind the “marvels” in question.

Generics: what’s in a name?

Precribing a drug by its generic name does not transform the drug into a generic one. A drug is only generic – and can only claim that name – if it has successfully passed the in vivo clinical trials which must be carried out for each pharmaceutical product. The results of these trials to certify bioequivalence and bioavailability must then be presented in accordance with international regulations which must be adhered to nationally. In this regard, Argentina is not compliant, given that ANMAT is far from being able to carry out these studies or have sufficient teeth to ensure this happens.

It is this lack of compliance with bioequivalence and bioavailability that prevents generics from qualifying as such – and which turns them into what are internationally considered to be copycat drugs.

Branded and generic drugs: the old story of Capulets and Montegues

As the International Community of Women Living with HIV/AIDS (ICW), our vision is clear.

We believe it is vital to carry out tests to confirm the quality of the drugs. It is also crucial that the State should implement a series of policies on generics which do not confuse the public with platitudes about the falling prices of analgesics or leave us not knowing what exactly we are taking. The medical aspects are complex - to the point of being categorised as a health risk by the World Health Organisation.

ICW Argentina has been carrying out a consultation over recent months with pharmaceutical companies located in Argentina who produce or sell ARVs. The results of this consultation on quality control systems are not encouraging.

We in ICW are in favour of quality drugs, whether these are branded or generic. We are strongly opposed to taking copycat ARVs – no matter how much the Ministry of Health argues that these ARVs (which the Ministry of Health labels “generics” but which are actually copies) bring down costs and optimise the AIDS budget.

Finally, ICW Argentina and the National Chapters of the 22 countries which belong to ICW’s Latin America and Caribbean region, have made a joint commitment, along with the regional representatives of the 57 countries around the world which are also part of the network, to lobby tirelessly, day and night, to bring down the costs of medication and to promote universal access to treatment for each and every one of the 40 million people around the world living with HIV and AIDS, but without compromising on the quality of the drugs we take each day.

This is our undertaking.

Patricia Pérez
Regional Secretariat, Latin America and the Caribbean

Patricia Pérez
Representante Regional para
América Latina y Caribe
Coordinadora Capítulo Argentino
ICW
www.icwlatina.org