In recent years the No es Sano (It’s Not Healthy) campaign has been carrying out actions to make the entire process for the approval and funding of new medicines and therapies by the National Health System transparent. In the exercise of the right to information, the campaign has made a series of requests to the Ministry of Health, through the Transparency Portal, to find out the real prices of different medicines – mainly the new and higher cost ones – as well as their impact on the budget.
In 2022, No es Sano presented a dozen of these requests. In all of them, the response from the Ministry of Health has always been the same with regard to funding: the prices of medicines are confidential as this allows Spain to buy them at a better price. This explanation forms part of the set of arguments which the pharmaceutical industry has used for years to prevent the disclosure of agreements made with public money, since keeping this information secret allows it to negotiate a different price with each state, depending on what each country is willing to pay, and even to set different prices within the same country in the negotiations between the companies and the hospitals themselves.
No es Sano maintains that, as these are pharmaceutical products paid for by the public, public interest must come above companies’ commercial interests. Therefore, the budgetary impact of each medicine on the public coffers should be known, also as an exercise in accountability and transparency.
Under this criterion, in the summer of 2022, the campaign appealed to the General Transparency Council – the independent body in charge of ensuring transparency in public activity – the Ministry of Health’s response to requests for information on two of these medicines: lanadelumab (Takhzyro), a drug for a rare hereditary disease, and remdesivir (Veklury), a drug against Covid-19.
“Prices will not be fair and affordable until there are fair negotiations, and fair negotiations are not possible when there is no transparency”, asserts the No es Sano brief. In it submissions, the Ministry itself recognises that “the need for ‘secrecy’ apparently collides with the required transparency of administrative action”, before setting out its arguments.
“Transparency of the Administration is fundamental, above all when has an impact on the growing public pharmaceutical spending. In a time when the sustainability of our health system is among citizens’s priorities, such obscurantism is not admissible”, argues Ileana Izverniceanu, Communication Director at OCU.
Backed by the Council
The Transparency Council has ruled in favour of No es Sano in both cases (Takhzyro and Veklury), urging the Ministry to share the requested information. “This Council does not appreciate the existence of the limits to the right of access to information invoked, so it is appropriate to uphold this complaint in order to provide the claimant with the information on the final price of the medicine paid by the National Health System,” it states in its response, in which it gives the Executive a period of 10 days to provide the information.
The Ministry of Health, however, has decided to appeal to the courts, lodging two contentious-administrative appeals against the favourable decision of the Transparency Council to allow citizens to have access to this information. No es Sano has intervened in this case through two of its promoter organisations, the Fundación Salud por Derecho and the Organisation of Consumers and Users (OCU).
“We cannot continue to allow the pharmaceutical industry to set the parameters for purchase negotiations for new pharmaceuticals, imposing secrecy”, states Vanessa López, director of Salud por Derecho. “We are talking about medicines acquired with public money, from our taxes, and the government must be transparent on this subject”.
“Transparency of the Administration is fundamental, above all when has an impact on the growing public pharmaceutical spending. In a time when the sustainability of our health system is among citizens’s priorities, such obscurantism is not admissible”, argues Ileana Izverniceanu, Communication director at OCU
History repeats itself
This is not the first time that No es Sano has been involved in such a case. In 2018, the company Novartis tried to prevent the Ministry of Health from making public the price of Kymriah, a novel therapeutic procedure, framed within the so-called cellular immunotherapies (CAR-T), to treat acute lymphoblastic leukaemia, through another contentious administrative appeal.
On that occasion, No es Sano requested the information from the Ministry of Health, which the Ministry also refused to share. The campaign organisations then appealed to the General Transparency Council, which ruled in their favour, asserting that this was not just a question of pharmaceutical policy, but of a right – that of information – which is a value intrinsic to the concept of democracy. Novartis, the company that markets the therapy, decided to go to court to block the process. In the ruling, the judge pointed out that the Ministry should have listened to the pharmaceutical company and heard its arguments at the beginning of the procedure. The litigation was thus paralysed due to procedural error.
With the current case, there are two essential differences: The Ministry of Health has previously given a period of allegations to the companies involved, so the outcome cannot be the same; and it is not the companies, but the government itself that has filed the lawsuit.