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
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 30/03/2011.