Because Italy and Trump will vivisection drug prices. Word of Aifa
On medicines we are facing an information asymmetry that all governments, including Trump, want to resolve”. The general director of Aifa (Italian drug agency), Luca Li Bassi, explains Italy's next moves on drug price transparency
START Magazine – 12 March 2019
The Ministry of Health, at the instigation of Aifa, has sent the WHO a proposal for a resolution on the transparency of the price of medicines: it will be discussed in Geneva at the next assembly (from 20 to 28 May). The general manager of Aifa, Luca Li Bassi, explains: "We report the price agreed with the pharmaceutical companies only to the Minister of Health and no one can reveal it".
Why secret prices?
The industries include confidentiality clauses in the contract in exchange for discounts. If you don't accept, they charge you a higher price.
Are they actually blackmailing you?
Yes. This is unacceptable, because we are a public institution that uses public resources and citizens need to know how their money is being spent. We don't know how much France, Germany and any other country spend on the same drug.
And so what?
We negotiate blindly. The list prices abroad must appear in the dossier presented to us by the company. But these are bogus because they don't take into account the hidden discounts. Two weeks ago at the meeting of the heads of European regulatory agencies there was the usual embarrassment. “I bet you spend too…”, we said to each other, but the answer was a bitter smile and absolute reticence.
Change the rules?
We have also begun to negotiate on price transparency: tell anyone who asks us even if we cannot publish it in the Official Gazette.
How many drugs are we talking about?
At least 1,800 medicines, equal to 57% of all hospital medicines (band H) and distributed in pharmacies (A-pht). Without transparency there can be no real competition. We cannot compare ourselves with other states.
Are you spending too much today?
Yes. A cancer treatment costs even more than 200,000 euros per patient. In addition to a European database in which to share drug prices, we ask WHO to include the costs incurred for research and development among the requirements for the registration of the molecule.
Another request from Italy is the publication of all the results of the clinical studies.
The industries select the test results, keep silent about some adverse effects, and we don't have the tools to establish the effective added therapeutic value of that drug.
Are there no European transparency laws?
Here I am. The first dates back to 1988 but like all subsequent ones it remains unfulfilled. We are faced with an information asymmetry that all governments, even President Donald Trump, want to resolve.
(extract from an interview published in the Fatto Quotidiano; here the full version)
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Transparency of the price of medicines, Minister Grillo presents the proposed resolution sent to the WHO
Ministry of Health – 13 March 2019
“Without transparency in the pharmaceutical market there can be no real competition. The cost of medicines is a very important issue for the country, because it is directly linked to the sustainability of the National Health Service. We must not be afraid of transparency, the markets must not fear a change in this direction which is increasingly necessary. Citizens are asking us for it, for whom access to treatment remains a primary need, and is essential for the future of our health systems".
Thus the Minister of Health Giulia Grillo opened the press conference for the presentation of the proposed resolution to the World Health Organization (WHO) on the transparency of the price of medicines. The conference was held on March 12 at the Ministerial Auditorium in Lungotevere Ripa; The Undersecretary for Foreign Affairs Manlio Di Stefano and the Director General of the Italian Medicines Agency (AIFA) Luca Li Bassi also attended, in the presence of the Undersecretary for Health Armando Bartolazzi.
"The draft resolution that I sent to the WHO stems from the need to address the issue of lack of transparency in the pharmaceutical sector and in particular of how prices are established - continued the minister - In Europe since 1988 there has been the Transparency Directive was issued, which unfortunately never achieved the transparency objectives it set for itself. Since then there have been numerous, albeit fragmented, initiatives on this important issue which, however, has never been tackled with a systematic and common approach at an international level. For these reasons, I have therefore sent this proposal for a resolution to the WHO, which will be discussed in Geneva during the next World Health Assembly, from 20 to 28 May. The 194 countries that adhere to the WHO will participate, plus other states present as observers, non-governmental organizations (NGOs), civil society associations, students associations, health professional societies, etc.”.
In summary, the motion for a resolution asks WHO to act in order to:
- collect and analyze data on clinical trial results and adverse effects of medicines and other health technologies;
- provide governments with a forum for sharing information on drug prices, revenues, R&D costs, public sector investment and R&D subsidies, marketing costs, and other related information;
- provide crucial information on the patent landscape;
- take further action through meetings and forums to foster further progress.
Lastly, Minister Grillo reiterated that Italy is the first country to have requested a recommendation on transparency in the pharmaceutical sector from a supranational body, such as the WHO, so that it can have a global impact.
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