Ministry outlines changes to Reimbursement Act

After months of consultation, the Health Ministry on 1 August unveiled a draft proposal of changes to the Reimbursement Act. The objective is to clarify certain interpretive issues that have arisen in the more than one and a half years since the Act’s coming into force, respond to concerns of market participants, particularly pharma firms, and address certain negative phenomena, such as shortages on the pharmacy market caused by higher exports of certain medicines, the ministry explains.

Proposed changes to the Reimbursement Act in Poland, August 2013
PMR, 2013
New pharmacy substitution rules that significantly increase the scope of products that can be dispensed
Abolition of the requirement for healthcare providers to buy reimbursed medicines at prices that do not exceed the reimbursement ceiling
New definitions of several terms, including “total reimbursement budget”, “wholesale price”, “retail price”, “drug programme”, or “the equivalent of the medicine” (which will no longer entail the same indications)
New provisions pertaining to the payback mechanism (it will be triggered only after the total reimbursement budget and the “pharmacy reimbursement budget” are exceeded, and the relevant amounts will be determined by the president of the National Health Fund, rather than the health minister)
Several changes pertaining to reimbursement decisions (e.g. more precise rules regarding their validity period)
New rules governing the determination of the net selling price that will e.g. make it easier to negotiate an increase
A clarification of provisions regarding the creation of limit groups
A restriction of the remit of the Economic Commission, which e.g. will no longer be tasked with monitoring the continuity of supply or reimbursed medicines or with negotiating the level of co-payment, as it follows directly from the Reimbursement Act
A streamlined application procedure regarding proposed reductions in the net selling price
Making the Main Pharmaceutical Inspectorate (GIF) responsible for monitoring the level and continuity of supply of reimbursed medicines, and ordering compensation for non-compliance, effective from 2017
Periodic assessments of HTA dossiers to be carried out by the Health Technology Assessment Agency (AOTM) every five years for medicines that do not have a reimbursed equivalent in a given indication (with some exceptions)
Less frequent publication of reimbursement list updates (every three months instead of every two months)
Changes to the procedure for direct imports of medicines on a named patient basis that extend the procedure beyond the pharmacy market to include medicines administered as part of chemotherapy
A new programme of individual access to oncological medicines, which is to replace non-standard chemotherapy
Giving the health minister the power to call on the authorised party to apply for the reimbursement and for the determination of the official selling price for a medicine