Pharmaceuticals for Special Needs

The Pharmaceutical and Pharmacy Inquiry has delivered its third interim report, “Pharmaceuticals for Special Needs” (SOU 2014:20).

The report deals with questions concerning:

• management and pricing of pharmaceuticals against infectious diseases;
• management and pricing of licensed pharmaceuticals;
• pricing of extemporaneous pharmaceuticals.

The report, which comprises few proposals, has thus far received a mixed reaction. Notably, the Swedish Pharmacy Association has been critical of the report on the basis of its proposal as to licensed pharmaceuticals.

Pharmaceuticals against infectious diseases

The majority of pharmaceuticals prescribed pursuant to the Communicable Diseases Act (2004:168) have been reviewed in accordance with the Pharmaceutical Benefits Act (2002:160) and given a price by the Dental and Pharmaceutical Benefits Agency (TLV). To avoid lack of clarity in the pharmacies’ pricing, the Inquiry is now proposing that it be made clear that the provisions in the Pharmaceuticals Benefits Act regarding price and the right of the pharmacies to negotiate on price is also to apply when the pharmaceutical has been prescribed under the Communicable Diseases Act.

The Inquiry’s assessment is that pharmaceuticals against infectious diseases that have not been reviewed under the Pharmaceutical Benefits Act could be subjected to a health economic evaluation within the framework of the clinical pharmaceuticals project conducted by the TLV.

At present, there is a lack of simple ways to monitor which pharmaceuticals – and associated costs – may come into play in fighting infectious diseases. To improve opportunities for monitoring and facilitate invoicing of county councils by pharmacies, the Inquiry proposes that the eHealth Agency should mediate these invoices (as in the case of pharmaceuticals covered by the pharmaceutical reimbursement system).

Licensed Pharmaceuticals

Each year, the Medical Products Agency grants about 68 000 applications for licences. Currently, it is the pharmacies that apply for a license, i.e. permission to sell a non-approved pharmaceutical, while it is the prescriber who explains the reasons why it is needed.

Today, the pharmacies pay a fee for each licence application made. This means that it can be costly for the pharmacies to sell a licensed pharmaceutical. But nor does the Inquiry propose changes to the fees.

When Apoteket AB ran all the pharmacies, patients could collect a licensed pharmaceutical from any pharmacy of their choosing irrespective of which pharmacy applied for the licence at the Medical Products Agency. In connection with the re-regulation of the market, this possibility ended, which led to poorer availability. This is because a licenced pharmaceutical now has to be picked up from a pharmacy in the same chain as the pharmacy that made the application. The Inquiry has found that a system could be created in which a decision on a license could apply at all pharmacies. This may, however, mean that it will be necessary to reconsider the way in which the Medical Products Agency’s work on applications is financed.

A further proposal concerning licensed pharmaceuticals is that they should be automatically covered by the pharmaceutical reimbursement system except in cases where the TLV has made a special decision on this. It is deemed to be inappropriate for TLV to undertake a value-based assessment when a new licensed pharmaceutical is to be prescribed and it is a matter of urgency for the patient to get access to this drug. 

Extemporaneous Pharmaceuticals

Extemporaneous pharmaceuticals are pharmaceuticals manufactured for a specific patient and are exempted from the requirement of approval. Extemporaneous pharmaceuticals also exist in the form of stock preparations (with or without a national licence) when they are manufactured in larger volumes to meet an expected need.

For extemporaneous pharmaceuticals, the TLV has set a list of rates showing the payment that the manufacturer is allowed to charge for the raw material and the work needed to produce a certain kind of preparation. In the case of stock preparations (with or without a national licence), the manufacturer applies to the TLV for a price for the stock preparation concerned.

The Inquiry has analysed the current practice for pricing and has considered whether another model for pricing could be applied to extemporaneous pharmaceuticals. The Inquiry has not found any more practical alternative and proposes that the current method should be retained. However, current practices should be regulated by statute so as to clarify the requirements that apply.

The future

The interim report is the third from the Pharmaceutical and Pharmacy Inquiry. The report will now be circulated for comments.

It is proposed that the suggested legislation, which above all applies to the management of the flow of information in the matter of prescriptions, pharmaceuticals and prices, is to enter into force on 1 January 2016.

The final report will contain proposals for orphan medical products, medicine dose dispensing service, and trade with pharmaceuticals for animals and will be presented no later than 30 October 2014.