From the point of view of the Commissioner for Human Rights, the issue of the age restriction in access to gene therapy is not over, said Stanisław Trociuk, deputy Ombudsman, during the Tuesday meeting in the Sejm, devoted to the problem of access to reimbursed gene therapy in the treatment of SMA.
The Ombudsman will continue to intervene in the matter of gene therapy
Published Aug. 31, 2022 13:18
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A meeting on the extension of the reimbursement criteria for gene therapy in SMA with the participation of parents of children suffering from spinal muscular atrophy was organized by the leader of PSL, Władysław Kosiniak-Kamysz. Stanisław Trociuk, the deputy of the Human Rights Defender, also took part in it, but there was no representative of the Ministry of Health. After the meeting, the Minister of Health Adam Niedzielski commented on its course on Twitter, describing Kosiniak-Kamysz a cynic and accusing him of playing on "the lowest human feelings".
The subject of the meeting - and mutual accusations (Kosiniak-Kamysz reciprocated Niedzielski with the epithet "coward) - are the reimbursement criteria for gene therapy in SMA. The drug will be reimbursed from September 1, while the inclusion criteria have been extremely narrowed compared to the manufacturer's criteria. In Poland, treatment with this drug will be available to children up to six months of age at the time of administration of the drug, who have not been treated with any SMA drug before and who have no more than three copies of the SMN2 gene.
The deputy Ombudsman, Stanisław Trociuk, who was present at the meeting, admitted that the Ombudsman took up the issue of access to gene therapy for people suffering from SMA based on media information. - We turned to the Minister of Health on this matter and received two responses. One more emotional, stating that we use populist arguments in correspondence to the minister of health. The second one, from the next day, is more substantive but, in our opinion, does not explain the essence of the problem, he said.
Trociuk emphasized that he views the problem from the perspective of a lawyer - and that the rights of the individual are his point of reference. - In your case (children who did not receive reimbursement treatment using gene therapy and their parents - editor's note), the key issue is whether the age criterion is adequate for the decision to reimburse this drug from public funds - he emphasized, recalling that the Constitution guarantees everyone the right to equal access to services financed from public funds. - Of course, there are deviations from this, but on the condition that it is based on a rational criterion. In this case, when it comes to health services, the criterion must be medical knowledge. If scientific research shows that the criterion for administering a given drug is the age of the treated person, then of course it cannot be accused of discrimination, he explained.
In the opinion of the Ombudsman, there are doubts as to the application of the age criterion at the level of 6 months. - The employees of the Ombudsman's office have preliminarily analyzed what it looks like from the point of view of the EMA, which approved this medicinal product for use. This analysis leads to the conclusion that this criterion of age of 6 months is questionable from the point of view of the description of this medicinal product. The indications contained in the EMA information indicate the age of 2 years or a body weight of 13.5 kg - he reminded, concluding that the Ombudsman would not abandon this case. - From the point of view of the Commissioner for Human Rights, this case is not over, he promised.
