Reference group initiated by parallel import and parallel distribution products

On 1 April 2017 parallel import and parallel distribution products will initiate a reference price group with the respective on-patent or off-patent original product. 

A generic reference price system has been in place in Finland since 2009, and a generic substitution system since in 2003. Currently, the forming of a reference price group has been initiated as soon as the first generic product with adopted reimbursement status has been launched to the market.

Today, the innovative medicine can be substituted by the PI product only within the generic substitution system. Substitution at the pharmacies has taken place to a modest degree only and the market share of parallel imports has been non-significant. The reform seeks to increase the use of parallel import products, thus also enhancing the price competition of medicines outside of the scope of the RPS.  As the change does not affect the maximum reimbursable price, it will not be reflected in the prices of other EU countries.

Parallel imports can launch the price competition in the context of the reference price system also for the original medicines that have so far been excluded from the generic substitution system, the reason being the disease in question or the dosage form or device of the medicinal product.   The requirements for parallel import and parallel distribution products are similar to those applied to a generic product to initiate a reference price group. The product has to be reimbursable and interchangeable with the original product. The parallel importer guarantees that there is a sufficient amount of the product available for the whole reference price period. However, there are no measures or sanctions to ensure that the amount of the product is actually sufficient.

PIF strongly opposed the proposal when it was prepared by the Ministry of Social Affairs and Health as well as during the parliamentary discussions on the savings package.

The reform will have a negative effect on the predictability of the operations of the member companies in Finland. Moreover, it would bring about major risks of medicine shortages. The change will also increase the workload of the companies because if the product is included in a reference price group that is initiated by a parallel import or parallel distribution product, it is subject to both the price notification procedure and the application procedure.