DZP wins battle over innovative treatment for patients

Since the Reimbursement Act came into effect, patients have been fighting to access treatment using innovative therapies. Frequently, the only hope they have is a targeted import procedure, which can be used to import medicines unavailable in Poland for the needs of individual patients. The targeted import procedure enables treatment to be provided with medicines whose price is generally beyond patients’ financial capacity.

The judgment passed on 9 February 2016 by the VAC in Warsaw could lead to a change favourable for patients in how reimbursement regulations are interpreted. In this judgment the VAC in Warsaw upheld the position we put forward in the appeal against the Minister of Health’s decision to refuse reimbursement for medicine for a boy suffering from muscular dystrophy. The boy’s condition required urgent treatment with a medicine currently unavailable in Poland.

Targeted import procedures are available for two types of product: those that are unavailable in Poland, and those that have not been registered in the European Union. According to a Ministry of Health interpretation, only the first are subject to financing pursuant to article 39 of the Reimbursement Act.

The court upheld the arguments of lawyers in our Life Sciences Practice that this interpretation was incompliant with the constitutional principle of equality and public authorities’ obligation to provide children with special healthcare. Restricting access to treatment for some patients merely because the medicine they need was admitted to trade in the European Union by way of a centralised procedure leads to the paradoxical situation where one decision gives the patient a chance of treatment while another – through a funding refusal – does not.

The judgment is not yet final; the Minister of Health could still file a cassation appeal against it. If, however, the judgment stands it could provide a source of hope for a wide circle of patients who are most in need.