In the coming months, the Ministry of Health will require laboratories to report the cost of production, research and development of a product, as part of the ordinary evaluation process to include it in the National Health System. Negotiations between health institutions and pharmaceutical companies still involve opaque processes and with this approach, assures the team of Minister Mónica García, it wants to advance in favor of transparency.
The measure, which is part of a process prior to setting prices, is part of a royal decree that regulates the assessment of health technologies and which has been in the public consultation phase since August. “The developer of a technology under assessment is required to provide reliable production, research and development costs, as well as the sources of financing for these costs, whether public or private,” states Article 23 of the draft text, which has not yet been published. approved. It has been approved by the Council of Ministers and may be subject to amendments. These technologies range from medicines to medical and surgical procedures.
“This is the first time that we will really have to know what they have invested. Until now, it was like the blind man’s chicken, which allowed them to maximize profits,” explains Ángel María Martín, vice-president of the Association for Equitable Access to Medicines (AAJM).
The organization is satisfied with the decision of Santé, although it has presented allegations to go further. They want the data provided to be decisive in setting prices, so that the profits that the laboratories pocket, which they consider excessive, are reduced to save money in the public coffers.
This is the first time they will be asked to actually know what they are investing in. Until now, it was like the blind man’s chicken, which allowed them to maximize profits.
Ángel María Martín, vice-president of the AAJM
In 1990, Spain approved a decree (271/1990) that stipulated that prices should be set on the basis of costs, “but in practice this decree is not respected, even though it has not been repealed,” says the AAJM, which hopes that this new regulation “will no longer be like a vase.”
In general, the price of medicines in Spain remains a mystery. The maximum cost that administrations can pay for treatments is known, but the amount paid for certain medicines is a secret that pharmaceutical companies and Health have kept for years.
However, last year, the team led by García changed the ministry’s position in two legal proceedings and wants to reveal how much Veklury (remdesivir) and Yescarta (axicabtagén ciloleucel), two treatments from the Gilead laboratory, cost. This change of direction is also confirmed in some way with the decree on the evaluation of health technologies, if the text as written in the draft is finally approved. The ministry also plans to adopt a new law on guarantees and rational use of medicines soon, which will include a section on prices, according to ministerial sources.
8% more pharmaceutical spending in Spain
Pharmaceutical spending in Spain increased from January to May, according to data provided by the AAJM based on those proposed by the Ministry of Finance, by more than 8% compared to the same period of the previous year, an increase of 761 million euros. In 2023, the total figure exceeded 23 billion. “The costs paid for medicines are very far from the production costs,” says the association, which regrets that this is “detrimental to public interests.”
The Provincial Court of Barcelona recently banned Teva Pharma from selling a widely used oral anticoagulant, marketed under the name Apixaban, whose patent belongs to another company (Bristol Myers Squibb). The version of the first pharmaceutical company – which has requested the expiration of the second’s patent – is generic and therefore has a much lower price.
The reestablishment of the monopoly is an unprecedented case, the result of the war between two companies, which will have implications for the public system and its patients: the autonomous communities will have to pay 380,000 euros more per day (138 million per year) to finance the additional treatments of 300,000 patients, according to The country. Each box of the generic costs 45% less (45.08 euros) than those of the branded drug (81.96 euros), called Eliquis. The Association for Fair Access to Medicines has asked the Ministry of Health to appeal this judicial decision in order to avoid an additional cost to the system.
