If medicines are equated to a consumer good

Among the first acts of the newly installed European Commission, the placing of the European Medicines Agency under the control of the Directorate of Industry. A move that "favors the economy but risks damaging patients", warns the Mario Negri Institute

EDITORIAL ⎪ THURSDAY 2 OCTOBER 2014, HD Healthcare

The news comes from insiders: the new European Commission, which has just taken office under the leadership of the Luxembourger Jean Claude Junker, reorganized the various European agencies among its first acts. In the midst of the restructuring, the agency responsible for the approval and control of medicines in Europe also ended up, the EMA which, from the directorate of Health and Consumers passed to that of Industry.

An apparently trivial fact that wouldn't deserve a line if someone hadn't tried to turn on the lights on what such a choice can mean. This was done by the scientific director of the Mario Negri Institute Silvio Garattini and the pharmacologist of the Vittorio Bertelè institute who in a editorial on the Mario Negri website descrivono il «disagio» causato dalla scelta. Innanzitutto, perché il passaggio dell’Ema sotto la giurisdizione dell’Industria è un ritorno: «sotto tale giurisdizione fin dalla sua nascita a metà degli Anni Novanta», scrivono i due farmacologi. «C’erano voluti oltre quindici anni per convincere la Commissione dell’inopportunità politica di quella collocazione: i farmaci – sostenevano più voci nell’ambito della comunità scientifica e delle associazioni dei pazienti – non sono assimilabili a qualsiasi altro bene di consumo. Lasciando l’Ema sotto l’Industria la Commissione dava l’impressione di privilegiare l’interesse commerciale rispetto a quello dei pazienti e della sanità pubblica».

Everything seems to change under the Barroso presidency, the Commission had moved Ema from the Directorate of Industry to that of Health and Consumers. «Not that things have changed much since then, on the contrary», point out Garattini and Bertelè. «The EMA continues to approve drugs that often have little documentation of efficacy. Many drugs are still approved today for a clinical benefit only supposed on the basis of surrogate evidence, assuming, for example, that reducing blood sugar or blood pressure undoubtedly avoids a heart attack or stroke and reducing tumor mass actually prolongs life. existence of patients or at least improve their quality», they continue. «In addition to leaving the clinical efficacy of drugs presumed, their innovativeness is advertised without proving it. New drugs are most often approved on the basis of their comparison with placebo or their non-inferiority to already available drugs for the same clinical indication. Everything contributes to producing copies of what already exists, without any possibility for doctors and public health operators to make rational choices based on the clinical value of a drug and its cost/benefit ratio compared to the others available. In this way, even for drugs as for all consumer products, generalized approval offers commercial pressure the opportunity to promote a product regardless of its actual value», they conclude in their criticism of the agency.

Now, "the exhumation of the political position of the EMA under Industry", which "certainly will not facilitate the long-awaited reconversion of the European agency to a role truly inspired by the primary interest of patients and public health".