The AIFA reform, which will lead to the departure of general manager Nicola Magrini on 23 January, was one of the first measures of the new Meloni government but appears to be a “lost opportunity” if not an “error” that generates a “conflict of interests”. The pharmacologist and president of the Mario Negri Institute Silvio Garattini94 years of which 70 dedicated to science, Fattoquotidiano.it explains why the new look ofItalian drug agency “this is not good news” and how the future structure presents many critical issues in a sector such as the pharmaceutical one dominated by economic interests rather than attention to citizens’ health. Not to mention that the drugs on the market, for which Italy spends 22 billion each year, are too many and “20-30%” could be eliminated.
The reform abolished the figure of the general manager, who had all the management powers and directs its activity, while the president of Aifa (currently the virologist Giorgio Palù) has become the legal representative of the agency. It will be a ministry decree of Health, together with the Public Administration and Mef and in agreement with the State-Regions Conference, to identify not only the functions, but also the procedures for appointing the president himself, as well as the administrative director and the technical-scientific director. The current two Commissions dealing with pricing and reimbursement and scientific evaluation of new medicines. There will be a new and single scientific and economic drug commission in place of Cts and Cpr.
Professor Garattini, you wrote that the Aifa reform is not good news. Can you explain to me why?
The Aifa reform is a lost opportunity because they have abolished the figure of the general manager. There will be a scientific director and an administrative director and this is not good because all the power and decisions remain within the presidency. It means that the president will carry out both the task of the board of directors, which is to control and give directions so that the activity goes in the best direction, but at the same time also the task of deciding: there is a conflict of interest. Even having two directors is not good because the administrative director who determines the conditions always prevails over the scientific one. We need a board of directors and a general manager. Then the tasks can be distributed differently. Then there is another problem.
It is right to have put together the group that decides scientifically (Cts) and the group that deals with prices (Cpr); with two groups no one is responsible for the decisions. A single commission is fine, but the expected one will be made up of only ten people. The pharmaceutical industry has become extremely complex and therefore there is no way that ten people can master everything, unless they are working full time. But if you want to choose capable and competent people, it will be difficult for them to work full-time. It is necessary to have more people destined for the commission, to have a technical secretariat that instructs the practices so that whoever has to judge has all the material available.
Are there any other problems?
One problem is that AIFA is the place where the quality of the protocols is decided. Anyone who has to carry out a controlled clinical study must go through Aifa, but then it is the Agency itself that indicates the results of those studies when it examines them for approval. Controller and controlled at the same time: thus there is a conflict of interest.
But in your opinion, how should the reform be?
Touch the organization more than the structure because as in all organizations I repeat there must be a board of directors and a general manager: having changed is a mistake. Constantly changing directors does not help the efficiency of an organization. Then there’s the fact that we spend a lot on drugs, 22 billion, but we have too many. The real changes have to go in the way Aifa operates. The formulary has not been reformed and revised since 1993 and it is necessary because we have drugs that are old and many that do the same thing but with different prices. That’s where you have to try to improve things. Medicines should not only be studied because they have quality, efficacy and safety; because that doesn’t tell us if they are better or worse than the existing ones. A new drug should be better than a drug that already exists for the same indication as Helsinki’s statement predicts, but this does not depend on AIFA. The best should remain in the handbook and the others be eliminated, but this does not happen because European legislation does not provide for it.
We have too many drugs, can you give me an estimate?
We have about 1200 active ingredients and probably a good percentage, 20 or even 30%, could be eliminated. Another problem is that drugs that do the same things shouldn’t be priced differently.
And can Aifa affect this?
He can decide on the question because there is a committee; the price issue is very delicate.
You have written in the past that the scientific part is essential to ethics and one cannot help but think of a reference to the so-called drug lobby
At European level there is no will to change the law: it must not be demonstrated that one drug is better than another because this is not foreseen. Each drug must meet quality, efficacy and safety requirements, but it does not have to demonstrate whether it is the best. This is good for the industry because everyone can argue that that drug works better, but comparative studies should be done and only the best should remain. This is in the interest of citizens and the national health service but not of the market. There is certainly a pharmaceutical lobby because it is obvious that whoever sells something tends to increase their turnover; it is a law of the market. But this is not the market for clothes or shoes, but for health and it must be a market that respects the interests of the sick. We have to decide whether drugs are for those who sell them or for those who use them.
And there is also the eternal theme of scientific research which must also be public
There cannot be only the private one. Information doesn’t just have to come from industry. Today, from whom does the doctor learn how drugs work, the side effects? From industry. There is no independent information for the doctor. There is a lack of independent research and independent information. Today the vast majority of controlled clinical trials are carried out in adult male subjects, while they can then be used in children and above all in elderly subjects with all their frailties. Even more penalized are women who should participate in specific protocols given that, for the same disease, women are different from men in terms of prevalence, duration and outcomes.
In your opinion, what is the greatest risk of this reform?
That there is no longer who decides and who controls in separate contexts. The real problem is the lack of a review of the formulary. It was planned when Minister Grillo was there (Conte government, ed), but it didn’t go ahead because the minister changed. Many of the 22 billion we spend on medicines each year could be put to better use: for example in the national health system. And then perhaps in research, because we are the country that spends the least. To be on par with France we would have to spend 20 billion more a year. We have about half as many researchers as the European average when we calculate it per million inhabitants. Unfortunately, this is true in all sectors: having few researchers means condemning the country to having little innovation.