A Law That Concerns Us

ČSH

The Public Health Insurance Act No. 48/1997 Coll. has undergone a series of amendments over more than twenty years. The Ministry of Health is now preparing a very significant change affecting people with hemophilia, specifically Section 16. It is very brief — (1) The relevant health insurance company shall, in exceptional cases, cover healthcare services not otherwise covered by the health insurance company, if the provision of such healthcare services is the only option in terms of the insured person's health condition. These three lines contain a very important provision that affects medications that are not commonly available on the market — that is, those not yet approved and without a set reimbursement. The reimbursement is determined by the State Institute for Drug Control, and both manufacturers and payers — i.e. health insurance companies — must comply with it. If such a medicine is not on the relevant list yet is urgently needed, the aforementioned Section 16 applies. This therefore also covers so-called innovative treatment — the administration of new medicinal products that are not yet available on the Czech market.

A seminar on the issue of Section 16 of the Public Health Insurance Act and the entry of innovative medicinal products to the market was held in the Chamber of Deputies under the auspices of the Health Committee. It was attended by representatives of the Ministry, insurance companies, SUKL, the Association of Innovative Pharmaceutical Industry, lawyers, and a representative of the Czech Hemophilia Society.

In a very open discussion, the needs of patients and efforts to achieve the easiest and fastest possible access to innovative medicines were discussed. In the case of hemophilia patients, these could be, for example, new treatments for patients with inhibitors, but also extended half-life products and the like. Even though the condition of being "the only option" is not met here, because concentrates with standard half-life are available, according to interpretation this section can also be applied to the introduction of modern products that will soon become commonplace. Importantly, none of the representatives of the decisive institutions objected to this accommodating view, and all expressed willingness to help such processes as much as possible. For example, there was discussion about the bureaucratic obstacle requiring original clinical studies from Czech sources, even though very extensive ones are available from abroad, where they have significantly larger patient samples and therefore more conclusive results.

The conclusions of the seminar look promising, and it clearly follows that in the future, the introduction of innovative medicines, even for very small numbers of recipients, could be significantly simpler. It will depend on whether legislators and, above all, the institutions concerned will adopt the beneficial ideas from the interpretation of the amended law as their own.