The Polish Parliament adopted a new law governing the reimbursement of medicinal products, medical devices and food for special medical purposes.

The mains changes with respect to the current reimbursement rules include:

  • official prices and reimbursement of products being decided by individual decisions of the Minister of Health; the applicant will have the right of appeal in an ordinary administrative process
  • extending the scope of the reimbursement to cover food for special medical purposes
  • introducing fixed (instead of maximum) selling prices and fixed wholesaler’s and retailer’s margins
  • reducing the wholesaler’s margin and changing the way the retailer’s margin is calculated
  • introducing risk-sharing arrangements into pricing and reimbursement decisions, including payment by results and price-volume arrangements
  • introducing a reimbursement ‘tax’ (3% of the annual value of the reimbursed product, based on the net selling price)
  • introducing a "payback" mechanism under which applicants who received decisions on reimbursement of their products will be obliged to compensate to the National Health Fund (the amount to be returned will be calculated according to a set formula) the costs of the increase in expenditure for reimbursement over the reimbursement budget
  • introducing administrative fines (varying in amount according to factors such as the value of the annual reimbursement of the product) for failures such as applying inappropriate price or inappropriate wholesaler’s or retailer’s margin or not using the required risk-sharing instrument
  • requiring applicants to accept enforcement measures (e.g. the excess amount and the reimbursement tax) in a notarial deed which they must submit before receiving a the decision on reimbursement.

Timetable

The draft law has been forwarded to the upper chamber of the Polish Parliament and will then go to be signed by the President. This is expected to happen by Summer 2011.

The Minister of Health will then request all marketing authorisation holders (or its representative) having their products reimbursed to provide the Minister with detailed information from other EU/EEA member states, including minimum and maximum prices, rebate schemes and product reimbursements, within 60 days.

In Autumn 2011, negotiations will take place on the net price and risk-sharing arrangements proposed by the applicant. The payer’s side will be represented by the Economics Committee - a special body comprising five members and created by the legislation.

After these negotiations, the committee will issue its recommendation and send it to the Minister of Health.

The Minister of Health will then issue a decision on reimbursement based on the recommendation and on price competition, taking into consideration the need for balance between the interests of payers and the pharmaceutical/food/medical sector.

There is no deadline for the Minister’s decision but it will need to be taken before the end of 2011 as it will take effect from 1 January 2012.

Other mechanisms described in the legislation will also come into effect on 1 January 2012.

Law: changes to Act on reimbursement of Medicinal Products, FSMP and Medical Devices