The TLV simplifies the generic substitution system

The generic substitution system, where pharmacies offer customers the cheapest medicine on the market, is not working optimally due to delivery problems. The TLV proposes an administrative simplification to secure the availability of medicines for pharmacy customers and decrease the risk of problems related to delivery.

- The TLV has initiated a cooperative forum for players in the industry where we monitor the substitution of medicines exposed to generic competition at pharmacies. The industry is currently in a learning curve and the medicine which a pharmacy should substitute to as "product of the month" is not always available.

These delivery problems affect pharmacy customers, pharmacies and prescribing doctors and lead to difficulties for customers in connection with substitutions at pharmacies. Our task is to ensure availability of medicines for pharmacy customers and for that reason we propose a temporary change, says Magnus Thyberg, Head of the Pharmacy Project at the TLV.

Three products become "products of the month"

This measure means that the TLV marks three products within each package size group as the "product of the month", instead of just one. A proposal to make this possible is now being circulated.

- Thanks to this measure pharmacies will have the possibility of more rapidly ordering the next cheapest product if the cheapest should prove to not be available. There will be a considerable increase in the reliability of deliveries, says Magnus Thyberg.

For pharmacies the proposal means that they shall order and dispense the cheapest alternative on the market, as has been the case up to now. In this respect the regulations will remain the same. The difference is that pharmacies will now be able to offer pharmacy customers the next cheapest product immediately if a delivery problem should arise. Pharmacies will not be able to choose freely between the three products.

The TLV will follow up and monitor proceedings to ensure the regulations are followed. The change is planned to come into effect on the 1st of May, 2010.

The TLV proposed previously that the "product of the month" should be extended from one to four months. Due to the current delivery problems the TLV will wait with extending these price periods during any current ongoing adjustment period.

Crucial for the proper functioning of the system is that pharmaceutical companies have the capacity to deliver the "product of the month" during the entire sales period which they bear responsibility for. In order to correct for these issues in the transition to the new system LIF (Swedish Association of the Pharmaceutical Industry) and FGL (Association for Generic Pharmaceuticals in Sweden) have produced a document "Quality Procedures for ensuring availability". Members of the associations bind themselves to following these procedures to ensure the substitution system works on the reregulated pharmacy market.