Publication of the minutes of negotiations with the Economic Commission

As part of what is known as the Major Amendment to the Reimbursement Act (frequently referred to using the Polish acronym “DNUR”), the updated Article 36(6) of the Reimbursement Act has introduced the obligation for the outcome of negotiations with the Economic Commission to be published, together with the minutes of such negotiations, in the event of a rejection, i.e. a resolution pursuant to which the Commission does not recommend that a medicine, a foodstuff for special nutritional use or a medical device be covered by reimbursement.

According to the new regulations, the outcome of negotiations, together with the minutes thereof, is to be published on the website of the Public Information Bulletin of the Ministry of Health, with the exception of information constituting a business secret within the meaning of Article 11(2) of the Act of 16 April 1993 on Counteracting Unfair Competition.

To our knowledge, the aforementioned provision has not been observed until now. The Ministry of Health, did, however, at the end of May, following negotiations with the Economic Commission in cases in respect of which no agreement was reached on the net selling price:

• begin to communicate that it plans to publish the minutes in question;
• begin requesting an indication of the scope of the business secrets that may not be contained in the content of final versions of negotiation minutes; and
• set a five-day deadline for responding to such requests, failing which an entity will be deemed to have agreed to the disclosure of all the information contained in minutes.

In view of the need to safeguard sensitive data, we recommend that special attention be paid to the element concerning business secrecy, including the preparation of a brief justification as to why a particular passage should be anonymised.

Quite apart from the issue of business secrecy, the practice of publishing data on the progress of negotiations with the Economic Commission is also becoming an important element of product-related communication.

As we have been highlighting since the entry into force of the aforementioned legislation, it is useful for such minutes to include brief information on:

• the disease in question;
• the (unmet) needs of patients; and
• the solution provided by the product for which reimbursement is being requested.

Every applicant in the proceedings has the right to contribute freely. As far as the minutes are concerned, the place where the applicant may include their comments is under the heading “Propozycja wnioskodawcy”:

If you have any questions, we will be happy to assist you.