DZP success – VAC judgment on agreeing upon medicine programmes

In view of the doubts over the correct procedure for agreeing upon medicine programmes, we would like to inform you of a new judgment that was issued by the Voivodship Administrative Court (VAC) in Warsaw (judgment of 14 November 2014, case no. VI Sa/Wa 731/14). The court overturned the Minister of Health's decision to refuse reimbursement for products in medicine programmes on the grounds that contrary to the provisions of the Reimbursement Act it had not agreed upon a medicine programme with the applicant but had merely relied on the national consultant's opinion. This unilateral step taken by the Minister of Health (MH) was deemed by the Court as premature, as in each case the content of a medicine programme should first be set by way of bilateral arrangement between the MH and the applicant.

The case before the MH and the VAC was handled by DZP lawyers, Tomasz Kaczyński, Senior Associate, and Szymon Łajszczak, Associate, in the Life Sciences Practice. 
In the appeal, we pointed out to the court that the provisions of the Reimbursement Act differentiate two independent phases of proceedings for product reimbursement in a medicine programme:

• medicine programme arrangements between the applicant and the MH and
• assessment of the basis for a product being classified as reimbursable.

The first phase was distinguished by the legislator in article 31(10) and (11) of the Reimbursement Act. According to these provisions, a substantive assessment of the application must be preceded by 60-day agreement upon the content of the medicine programme between the MH and the applicant.

In the proceedings preceding the issue of a decision at first instance, only the stances of external entities were gathered; no agreements were made between the applicant and the MH.
The court upheld the arguments put forward in the appeal that the steps taken by the MH transgressed article 31(10) and (11) of the Reimbursement Act. As the VAC stressed, the MH may not assume beforehand that a negative opinion on a medicine programme originally formed by the national consultant continues to apply where it is possible to make arrangements aimed at a compromise specification of the content of a medicine programme that would enable a product to be classified as reimbursable in accordance with statutory criteria.

As the legislator clearly introduces the concept of agreeing upon the content of a medicine programme, proceedings deprived of bilateral arrangements between the applicant and the MH would have to be deemed unlawful.

Consequently, the court upheld the stance taken by DZP in which, in light of the different stages of the proceedings over reimbursement of products in a medicine programme:

• in the first phase of the proceedings, according to article 31(11) of the Reimbursement Act, the proceedings may only end due to the failure of the MH and the applicant to agree upon the content of the medicine programme;
• the grounds for a product being classified as reimbursable can only be assessed at the second stage of the proceedings;
• an assessment of the grounds for a product being classified as reimbursable at the first stage and leading to the agreement process being interrupted or a refusal to instigate this process should be deemed premature.

The case in question is already the second case that DZP has won in recent months against the MH. Earlier, in a judgment of 9 September the Supreme Administrative Court (case no. II GSK 998/13) upheld our appeal, overturning the MH's act on the matter of an official interpretation of the provisions of the Reimbursement Act. In its judgment the court ordered the MH to make a substantive assessment of the application for an interpretation of the provisions of the Reimbursement Act filed pursuant to the Act on Freedom of Enterprise. It also pointed out that proceedings to issue an interpretation are regulated by the Code of Administrative Procedure and therefore the Minister cannot refuse to issue an interpretation without running proceedings and ending them with a decision or order.