{"id":35768,"date":"2024-04-29T11:01:01","date_gmt":"2024-04-29T10:01:01","guid":{"rendered":"https:\/\/faus-moliner.com\/el-acceso-a-los-medicamentos-y-los-derechos-constitucionales\/"},"modified":"2024-05-06T16:21:42","modified_gmt":"2024-05-06T15:21:42","slug":"el-acceso-a-los-medicamentos-y-los-derechos-constitucionales","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/en\/el-acceso-a-los-medicamentos-y-los-derechos-constitucionales\/","title":{"rendered":"Access to medicinal products and constitutional rights"},"content":{"rendered":"\n

Gutron\u00ae Case (High Court of Justice of Galicia): reimbursement of expenses and right to health protection<\/strong><\/p>\n\n\n\n

Judgment 756\/2024 of the High Court of Justice of Galicia of 7 February 2024 deals with a request for reimbursement of expenses made by a patient to the Galician Health Service (\u201cSergas\u201d). The claim was for payment of the expenses incurred in the purchase of Gurton\u00ae, a medicinal product indicated for a serious illness, but which was excluded from the pharmaceutical provision in 2005. In this case, despite being excluded from the pharmaceutical provision, the Sergas doctors prescribed the medicinal product because there was no therapeutic alternative, and they considered such product \u201cessential for the control of the patient\u00b4s illness\u201d.<\/p>\n\n\n\n

Sergas, however, refused to reimburse the costs and the patient appealed against such decision.<\/p>\n\n\n\n

The ruling stands out, firstly, because it considers that the exclusion of this product from the pharmaceutical provision seems to affect the guiding principle of health protection, contained in art. 43.1 of the Spanish Constitution. In this regard, the Court points out that it can be concluded that \u201cif the medicinal product prescribed by SERGAS itself -without an alternative- was not administered, this would result in damage to health that could even fall under the concept of a vital emergency\u201d.<\/p>\n\n\n\n

On the other hand, the judgment recalls that the concept of \u201cvital emergency\u201d cannot be limited to a risk to life itself. The Court points out that the current state of social protection in health matters, derived from the constitutional mandate of the right to health protection, implies the need to consider as \u201cvital emergency\u201d situations of \u201cplausible risk of loss of functionality of organs of great importance for the development of the person\u201d.<\/p>\n\n\n\n

In the light of the foregoing, the appeal is upheld and Sergas is ordered to reimburse the costs.<\/p>\n\n\n\n

Translarna\u00ae case (Supreme Court): principle of equality and evidence to be presented by the patient<\/strong><\/p>\n\n\n\n

Much has been written about access to Translarna\u00ae. It is possible that much of what has been said needs to be revisited following the European Medicines Agency\u2019s recommendation last January not to renew the marketing authorisation for this product.<\/p>\n\n\n\n

Nevertheless, we think it is relevant to comment on the Judgement 264\/2024 of Supreme Court, which analyses a patient\u2019s denial of access to this product.<\/p>\n\n\n\n

The case started when the family of a minor requested access to Translarna\u00ae via Royal Decree 1015\/2009 on access to medicinal products in special situations. Together with the application, they provided a certification issued by the Spanish Duchenne patients\u2019 association to prove that at that time, in Spain, there were 33 patients receiving Translarna\u00ae. The certification detailed the starting date of the treatment, the hospital where it was provided and the Autonomous Community.<\/p>\n\n\n\n

The hospital refused to send the application to the Spanish Medicines Agency, arguing that it was a medicinal product with an express resolution of non-funding; and that various internal, state and regional reports casted doubts on the efficacy of the product.<\/p>\n\n\n\n

The patient\u2019s family considered that the refusal was contrary to the right to equality, as they had provided sufficient proof that in other Autonomous Communities there were patients with the same conditions who were receiving the treatment.<\/p>\n\n\n\n

The appeal was upheld at first instance, but the High Court of Justice of Catalonia (TSJC) subsequently overturned the ruling, stating that \u201cthe principle of equality prohibits discrimination, but not a difference in treatment when it is based on a justification\u201d. According to the ruling, this justification existed because \u201cthe hospital\u2019s refusal to request authorisation (\u2026) is based on reports issued by different institutions at state and regional level, together with the fact that the medicinal product is not available on the list of publicly financed medicinal products\u201d.<\/p>\n\n\n\n

Regarding the fact that other patients were receiving treatment with this product, the TSJC considered that the certification submitted by the minor\u2019s family was insufficient; and downplayed the relevance of this evidence by stating the following: \u201cthere has been no comparison, there is no information on what type of patients are involved, nor under what conditions and circumstances such authorisations have been granted, there are no reports of the circumstances of each of the patients taking [Translarna\u00ae] or who have been prescribed this medicinal product, on which the possible discrimination, and therefore the violation of the right to equality, can be based.\u201d<\/p>\n\n\n\n

The Supreme Court, in cassation, considers whether or not it was correct to deny access to the product arguing that the applicant should have accredited the individualised circumstances of the patients who did receive the treatment; and concludes that the TSJC violated the right of the minor not to suffer discrimination and violated the right to equality in access to the pharmaceutical provision.<\/p>\n\n\n\n

The Supreme Court does not analyse whether the requirements for the exceptional authorisation requested by the patient were met, but sympathises with the idea that it was practically impossible for the patient to prove the individual circumstances of other patients, given that he could not have access to their medical records.<\/p>\n\n\n\n

That said, the Supreme Court points out that if a patient alleges infringement of the principle of equality and provides reasonable indications of discrimination, it is up to the defendant administration to rebut them. In this case, the Supreme Court considered that such reasonable evidence had been provided and that the TSJC could not justify the refusal of treatment by pointing out that the patient had not proved that his circumstances were equal to those of other patients. In this regard, it concludes that the TSJC transferred to the plaintiff the burden of an \u201cimpossible action\u201d, without taking into account the criteria for the distribution of the burden of proof established in the Spanish Civil Procedure Law, i.e. availability and ease of proof for each party.<\/p>\n\n\n\n

Raxone\u00ae case (Supreme Court): evidence to present when alleging a violation of the right to live<\/strong><\/p>\n\n\n\n

In the case of this Judgment 610\/2024 of 11 April, the facts refer to the refusal of the Extremadura Health Service to supply the medicinal product Raxone\u00ae to a patient. Raxone\u00ae is a product not included in the pharmaceutical provision of the NHS.<\/p>\n\n\n\n

At first instance, it was declared that preventing access to this product would violate the patient\u2019s fundamental right to life and equality. The High Court of Justice of Extremadura, however, held that there was no such violation of rights. Finally, the Supreme Court upholds the appeal and confirmed the patient\u2019s right to access to Raxone\u00ae.<\/p>\n\n\n\n

As in the Translarna\u00ae case, the Supreme Court criticizes the High Court of Justice of Extremadura for having required the patient to prove that, in his case, the same circumstances were present as in other cases where access to Raxone\u00ae had been approved. The Supreme Court confirms that the patient cannot be required to prove the individualised circumstances of the other persons to whom Raxone\u00ae has been administered. Nor does it consider the mere reference to the fact that Raxone\u00ae is not financed as a sufficient objective and reasonable justification for denying access to the product\u00ae.<\/p>\n\n\n\n

Conclusion<\/strong><\/p>\n\n\n\n

The judgments we have discussed are a good example of how the interpretation of some constitutional provisions is evolving, when access to treatments is at stake.<\/p>\n\n\n\n

The Translarna\u00ae and Raxone\u00ae judgments represent a step forward in terms of equal access to medicinal products in special situations in Spain. Recognising that the burden of proof cannot be imposed to demonstrate the circunstances under which access to certain products is being provided in other Autonomous Communities will help to reduce existing inequalities between territories. The Gutron\u00ae judgment, on the other hand, is a good example of how to interpret the guiding principle of health protection in relation to the right to life and physical integrity, especially in cases where there is no therapeutic alternative to treat a particular disease.<\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Gutron\u00ae Case (High Court of Justice of Galicia): reimbursement of expenses and right to health protection Judgment 756\/2024 of the High Court of Justice of Galicia of 7 February 2024 deals with a request for reimbursement of expenses made by a patient to the Galician Health Service (\u201cSergas\u201d). The claim was for payment of the… <\/p>\n

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