Rare Disease Expert Centres – joint chamber position

  • 27 listopada 2025
  • Category: Advocacy News
Together with the French-Polish Chamber of Commerce and the Polish-German Chamber of Industry and Commerce, AmCham submitted comments on the Ministry of Health’s draft amendment concerning the organisation of care for patients with rare diseases.

Our chambers welcome the Ministry’s initiatives aimed at improving conditions for patients with rare diseases, including efforts to expand access to diagnostics and treatment, as well as the proposal to establish Rare Disease Expert Centres (OCER). At the same time, we noted several issues which, in the current form of the draft, may raise concerns about the effectiveness and practical feasibility of the proposed solutions.

In our submission, we highlighted several key points:

  • overly general and cumulatively binding criteria for obtaining OCER status, which may significantly limit the number of eligible centres—particularly smaller institutions—and risk unequal patient access to specialised care;

  • the absence of a statutory deadline for issuing the implementing regulation defining OCER requirements, which may delay the application of the new rules;

  • the lack of incentives for institutions applying for OCER status, despite earlier announcements by the Ministry.

We asked the Ministry to reconsider these provisions to ensure that the system is both effective and workable in practice, ultimately improving access to specialised care for patients with rare diseases.