The latest changes in drug programmes that came into effect on 1 May could lead to the full-year reimbursement budget being exceeded, thus triggering the payback mechanism, the National Health Fund (NFZ) says in an explanatory memorandum to a draft regulation implementing the changes, which was published for consultation on 10 May.
This drew a warning from the Polish Association of Pharma Employers Producenci Lekow PL, which brings together domestic drug makers.
Domestic manufacturers of cheaper generic medicines generate substantial savings for the NFZ – the Fund already saves PLN 500m (€117m) a year thanks to generic competition, and the advent of biosimilar medicines could hugely increase that amount – so it is unfair and unreasonable to punish them for what is a consequence of the NFZ’s financial indiscipline, or its refusal to accept that drug consumption has to rise due to demographic factors, the Association’s president Krzysztof Kopec said in a statement on 11 May, quoted by rynekaptek.pl.
Many countries, one example being Belgium, exclude the generics sector from the payment of payback. In Poland, payback would mainly hurt generic manufacturers, and especially domestic drug manufacturers, because of their high market share and because companies that have concluded so-called risk-sharing agreements with the Health Ministry are exempt from it. The Romanian case shows just how short-sighted and dangerous payback can be – fearing payback, drug manufacturers in Romania reduced supplies to the market, which led to shortages of medicines in pharmacies. Payback can hurt patients the most and it will constrain investment in the domestic pharmaceutical sector and limit its growth, Mr Kopec pointed out.