No more secret prices for new drugs
No more secret prices for new drugs
Cancer, neurodegenerative problems and rare diseases. They are all serious ailments with something in common: scientists have made important advances in their treatment. The arrival of new therapies brings enormous hope to thousands of people. However, including them in the public healthcare system is challenging. Some of these drugs have astronomical costs, which can reach or exceed one million euros per patient. Spain’s public agencies, which negotiate with industry what they will pay, treat those prices like state secrets.
At Civio we believe that this opacity leaves countries negotiating blindly and worse. Moreover, we believe that the best weapon to fight corruption is transparency. That is why, since our first Medicamentalia investigation, we have been determined to shed light on the real prices of health treatments. We have done so by sifting through thousands of public contracts, both in Spain and abroad. Since 2019, we have also been trying to do use the Medicines Act and the Transparency Act: when Spain’s public healthcare system agrees to pay for a drug, the Ministry of Health issues a secret resolution spelling out the real price and terms. We believe that this document should be public information.
We have been asking the Ministry of Health for almost four years for all the resolutions it has issued to pay for very expensive treatments within the public healthcare system. We did so with CAR-T therapies (Kymriah and Yescarta), intended to treat different types of cancer, whose maximum price exceeds 300,000 euros. Then we followed up with Luxturna, a drug against vision loss, which has a maximum cost of around 700,000 euros. We then requested the price of Zolgensma, the treatment for a degenerative neuromuscular disease with a maximum price tag of around two million euros per patient. Unfortunately, we have gotten the door slammed in our faces each time.
We believe that all citizens have a right to know this information. For this reason, we have appealed all of the Ministry of Health’s refusals to the Council for Transparency and Good Governance. The council had previously accepted that the prices of medicines should be confidential. Until Civio came along. We convinced them, with the law in hand, of the need to shed light on this issue of great public interest: access to new treatments and the sustainability of the National Health System. Unfortunately, the Ministry of Health has not changed its stance, which continues to promote secrecy and opacity, repeating the same arguments as the pharmaceutical industry.
Not only that: as we already reported in July 2022, the Government and several companies have taken us to court several times seeking to void the Transparency Council resolutions. So we will continue this battle in the courts, whatever it takes, to ensure that the money we all pay for each and every one of these new medicines is no longer a mystery.
In a nutshell
Our trials in detail
YESCARTA axicabtagene ciloleucel
- Marketed by the pharmaceutical company Gilead Sciences.
- The laboratory has commercial exclusivity (there are no other potential competing drugs on the market).
- It is for adult patients diagnosed with two types of blood cancers (lymphomas).
- It is a treatment in which the patient’s cells are extracted and genetically modified so that they can then recognise and precisely attack the cancer cells.
- The maximum price set in Spain is 327,000 euros, a figure that does not coincide with the real cost borne by public agencies, the amount of which we exclusively disclosed after finding several related public contracts.
- It has been offered through Spain’s national health system since 2019.
Chronology
2019
Civio asks the Ministry of Health via an access request for the resolution detailing the real price and financing conditions negotiated in secret with Gilead Sciences. The Government does not answer our request. We file a complaint with the Council for Transparency and Good Governance to request protection against administrative silence.
2020
The Transparency Council upholds our complaint and admits that the resolution with the real price of Yescarta is public information. Thanks to Civio’s arguments, the CTBG changes its criteria and accepts that the costs of medicines should not be opaque. Moreover, it gives the Ministry of Health ten days to hand over the information.
The Ministry of Health and the pharmaceutical company Gilead Sciences file a contentious-administrative appeal against the Council’s resolution. Civio is an intervening party.
2022
The Central Contentious-Administrative Court No. 3 upholds the appeal filed by the State Attorney’s Office and points out that Gilead Sciences, owner of the therapy Yescarta, lacked the opportunity to present allegations in the proceedings before the Transparency Council. The court orders an administrative retrospective ruling so that the company could make a statement before the CTBG issues a second resolution.
Gilead Sciences presents its case, which included a series of accusations against Civio bordering on the conspiratorial. We respond by arguing that the resolution with the real price of Yescarta is public information and that there is a clear public interest in accessing this data. The Transparency Council again rules in favour of Civio, urging the Ministry of Health to deliver the requested information within ten days.
2023
The Ministry of Health takes the Transparency Council to court over the resolution. Civio is one of the parties involved in the proceedings. In this case, both the CTBG and Civio have submitted their respective responses to the lawsuit in defence of the right to know.
Gilead Sciences also takes the Transparency Council to court over the resolution. Civio is also a party to the proceeding.
We wait!
LUXTURNA voretigene neparvovec
- Marketed by the pharmaceutical company Novartis.
- The laboratory has market exclusivity (there are no other potential competing drugs on the market).
- It is for children and adults with an inherited dystrophy affecting the retina, a rare disease that can cause progressive blindness.
- It is a gene therapy that does not cure the condition but improves vision by injection into the retina.
- The maximum price set in Spain is 345,000 euros per eye, which is not the actual price government agencies pay in practice. We know that thanks to several related public contracts Civio found in its reporting of this exclusive.
- It has been included in the National Health System since 2021.
Chronology
2021
Civio asks the Ministry of Health via access request for the resolution specifying the real price and financing conditions negotiated in secret with Novartis. The Ministry does not respond within the deadline established by law. Civio files a complaint with the Transparency Council for administrative silence.
Subsequently, and after the legal deadline, the Ministry of Health responds to our request by refusing to grant access to this information. The reason given for limiting our right is that knowing this data would imply a breach of confidentiality and of economic and commercial interests.
The Transparency Council upheld our complaint on formal grounds. In addition, it urges the Ministry of Health to give Novartis the opportunity to present allegations and then issue a new decision.
Subsequently, the Ministry of Health issues a second resolution, which include Novartis’ arguments, in which it again denies Civio’s request for access to the real price and financing conditions of Luxturna. In the resolution, the Ministry admits that secrecy clashes with “the required transparency of administrative action,” especially in matters that affect “the coffers of the public treasury.” Even so, it limits the right of access to avoid violating confidentiality and to protect national interests, it claims.
Civio files a second complaint with the Transparency Council defending the right to know this information.
2022
The Transparency Council upholds our complaint and rules that the resolution with the real price of Yescarta is public information. It also gives the Ministry of Health ten days to provide the information.
The Ministry of Health and the pharmaceutical company Novartis file a contentious-administrative appeal against the Council’s resolution. You can read the Ministry of Health’s lawsuit here. Civio is an intervening party.
2023
Civio submits a response to the lawsuit defending the right to access public information on this therapy, in line with what has been postulated by the Transparency Council. You can read our response here.
The Ministry of Health, Novartis, the Transparency Council and Civio present their conclusions.
The Central Contentious-Administrative Court No. 9 of Madrid, attached to the National High Court, rejects the appeals filed by the Ministry of Health and Novartis. The ruling, which supports the position of Civio and the Council for Transparency and Good Governance (CTBG), is not yet final, although this is an important judicial victory in favour of transparency.
Novartis and the Ministry of Health have lodged an appeal against this judgment before the Chamber for Contentious Proceedings of the National High Court (Audiencia Nacional).
Civio and the Council for Transparency and Good Governance oppose the appeal by the Ministry of Health and Novartis.
We wait!
ZOLGENSMA onasemnogene abeparvovec
- Marketed by the pharmaceutical company Novartis.
- The laboratory has commercial exclusivity (there are no other potential competing drugs on the market).
- It is used to treat spinal muscular atrophy in young children, a rare and very serious disease, considered the leading genetic cause of infant mortality.
- It is a gene therapy that does not cure the condition, but helps to reduce the symptoms of the disease and improve patients’ quality of life.
- The maximum approved price in Spain is 1,945,000 euros, which is not the actual price government agencies pay in practice. We know that thanks to several related public contracts Civio found in its reporting of this exclusive.
- It has been included in the National Health System since 2021.
Chronology
2021
Civio asks the Ministry of Health via access request for the resolution specifying the real price and financing conditions negotiated in secret with Novartis. After not receiving a response by the legal deadline, we file a complaint with the Transparency Council due to administrative silence.
2022
The Ministry of Health, albeit belatedly and after receiving the pharmaceutical laboratory’s arguments, refused to grant access to this information. They argue that disclosing this data would violate the guarantee of confidentiality and secrecy required, as well as the protection of economic and commercial interests and national interests. The Ministry of Health repeats these same arguments in its submissions to the Transparency Council.
Subsequently, Civio rejects the arguments of the Ministry of Health and Novartis, arguing that knowing the real price paid for Zolgensma is of enormous public interest and that there is no obligation of confidentiality in relation to the cost of this therapy for the Ministry.
The Transparency Council upholds our complaint and points out, once again, that the real price and financing conditions should be public information. Furthermore, it gives the Ministry of Health ten days to provide the information.
2023
The pharmaceutical company Novartis files a contentious-administrative appeal against the Council’s resolution. Civio is a party to the appeal.
Later, the Transparency Council and Civio presented their respective responses to the complaint, defending in any case that the resolution requested is public information and that all citizens have the right to access it.
The Central Contentious-Administrative Court No. 4 of Madrid, attached to the National High Court, rejects the appeal filed by Novartis. The ruling, which supports the position of Civio and the Council for Transparency and Good Governance (CTBG), is not yet final, although this the second important judicial victory in favour of transparency.
Novartis has lodged an appeal against this judgment before the Chamber for Contentious Proceedings of the National High Court (Audiencia Nacional).
Civio and the Council for Transparency and Good Governance oppose the appeal by Novartis.
We wait!
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