The procedures for setting prices and applying for reimbursement
of pharmaceuticals and medical devices is to be fundamentally
changed.
The changes are set out in draft legislation which has been
accepted by the Council of Ministers and is due to be submitted to
Parliament in the next couple of days.
The changes are currently planned to take effect from 1 January
2012, although some provisions will come into force as soon as the
legislation is passed and announced, and others nine months
later.
Key changes include:
- determining all prices and reimbursement procedures by individual decisions of the Minister of Health, with a right of appeal against them in a standard administrative process
- extending the reimbursement procedure to cover food for special medicinal purposes (FSMP)
- introducing fixed (instead of maximum) prices for official selling prices and wholesaler's and retailer's margins, as well as reducing the wholesaler's margin to 5% and changing the way the retailer's margin is calculated
- introducing risk-sharing elements 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), with the Minister of Health yet to decide on its final destination
- introducing a system of payback under which the applicant receiving a reimbursement decision has to pay back an "excess amount" (calculated by a set formula) to the National Health Fund whenever the reimbursement budget (ie 17% of the public funds assigned to finance guaranteed healthcare benefits) is exceeded
- introducing administrative fines (varying in amount according to factors such as the value of the annual reimbursement of the product) for failures such as using the wrong price or wholesaler's or retailer's margin or not using a risk-sharing element required by the decision
- requiring applicants to submit a notarial deed before they are issued with a decision in which they accept enforcement of measures such as the excess amount and the reimbursement tax
- requiring pharmacies to enter into individual agreements with the National Health Fund in order to be able to trade in reimbursed products
Before the changes take effect, businesses with products on the
current reimbursement list will be invited to negotiate prices for
those products with the Ministry of Health. This means that
reimbursement would not be automatic for all products which
are currently reimbursed, as was originally proposed.
The draft legislation has been heavily criticised by the Ministry
of Finance and the Office for Competition and Consumer Protection
as well as by pharmacists, wholesalers and pharmaceuticals'
producers. They argue that a number of provisions are incompatible
with the Polish Constitution because they involve significant
interference into the market for reimbursed products. If passed
into law in its current form, it would create one of the most
restrictively regulated pricing and reimbursement system in the
EU.
This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq
Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.
The original publication date for this article was 15/10/2010.