The Supreme Court has highlighted the importance of equal access to treatment, the need for transparent justification by administrations and the responsibility of the national health system in deciding on treatments for rare diseases. The decision underlines that the mere lack of public funding is not a sufficient reason to deny a necessary treatment, and that rationality in pharmaceutical spending must be balanced with patients' right to health and life.
In this case, the Supreme Court has set an important precedent in relation to access to medicines that are not publicly funded, especially in the context of rare diseases. The key points of the Supreme Court's decision are detailed below:
1. Right to Physical Integrity and Equality:
- The SC has concluded that denying access to a medicine authorised for other patients in different autonomous communities may violate the right to physical integrity and equality if the reasons for the authorisations in other cases are not adequately justified.
- Equal access to treatment is crucial, and the lack of justification as to why other patients received the medicine implies unfair discrimination.
2. Need for the medicine:
- The medicinal product in question was found to be the only treatment available and approved by the health authorities for the patient's condition.
- The existence of prior authorisations in other autonomous communities reinforces the need and effectiveness of the treatment, justifying its use in this case as well.
3. Competence of the National Health System:
- The decision on the inclusion of medicines in the portfolio of services is not the exclusive competence of the autonomous community, but of the National Health System.
- The authorisation of the medicine for other patients demonstrates that the national system recognises the need for the treatment, regardless of public funding.
4. Fulfilment of Requirements:
- The patient fulfilled all the necessary requirements: medical prescription, report of the need for treatment, duration of treatment and informed consent.
- The refusal by the regional administration, despite meeting these requirements, was not adequately justified.
5. Burden of Proof:
- The SC states that it is not the patient's responsibility to demonstrate the individualised circumstances of other patients who have received the medicine.
- The administration should provide clear and detailed justification for its decisions, especially when there are precedents for authorisation for other patients in similar situations.
