Pharmaceutical products for animals, automated dose dispensing of pharmaceuticals and pricing of orphan medicinal products

The Pharmaceutical and Pharmacy Inquiry’s remit was to review certain issues concerning pricing, availability and market conditions in the pharmaceuticals and pharmacies area. The Inquiry’s final report, presented in December 2014, deals with the parts of the remit that concern trade in pharmaceutical products for animals, automated dose dispensing of pharmaceuticals and pricing of orphan medicinal products.

Remit

The Inquiry was instructed to:

• analyse and submit proposals on how to improve availability of pharmaceuticals for animals;
• analyse and submit proposals that could lead to favourable conditions for effective competition in the field of automated dose dispensing of pharmaceuticals; and
• if deemed necessary, propose a separate pricing model for orphan medicinal products.

Pharmaceuticals for animals

The Inquiry doses not present any major suggestions regarding pharmaceuticals for animals. It has analysed whether pharmacies that only sell pharmaceuticals for animals should be allowed. The Inquiry considers that the present obligation on the part of all retail pharmacies to provide all prescribed pharmaceuticals for animals should remain in place. As specialisation has proved possible within the framework of the current regulations for retail pharmacies, the Inquiry sees no reason to create any special regulatory framework for pharmacies that only sell pharmaceuticals for animals. Requirements on pharmacies’ stock-keeping have been considered but are deemed to be difficult to implement. The Inquiry considers that the possibility should not be introduced for veterinary practices to acquire pharmaceuticals directly from wholesalers beyond the current rules concerning vaccines and serums. This kind of structure is deemed to risk resulting in a lack of sales for retail pharmacies. Further, the Inquiry has decided not to propose that certain non-prescription
pharmaceuticals for animals be sold at places other than retail pharmacies.

The Inquiry’s analysis indicates that compliance with the cascade principle in the prescription of pharmaceuticals is relatively good. However, it considers that the supervisory agencies need better data to be able to monitor prescriptions. The Swedish Board of Agriculture, the county administrative boards and individual veterinarians should be given access to information on individual veterinarians’ prescriptions by the Swedish eHealth Agency. This is expected to contribute to better compliance with, and monitoring of, the cascade principle.

Automated dose dispensing

Automated dose dispensing means that pharmaceuticals are repacked into dose bags that are labelled with information about the patient and the pharmaceutical product contained in the bag.

Automated dose dispensing is procured by the county councils. The pharmaceuticals are paid for in the same way as regular outpatient pharmaceuticals. The county councils pay the dose providers for dose dispensing – known as the ‘dose payment’. The substitution rules in the pharmaceutical reimbursement system also apply to automatedly dispensed pharmaceuticals, but they are difficult and expensive to apply. The Inquiry’s conclusion is that the pharmaceutical reimbursement system should continue to apply to automatedly dispensed pharmaceuticals, but that the substitution regulations should be adapted to doses. The main proposal is that a player involved in automated dose dispensing may substitute automatedly dispensed pharmaceuticals, but does not have to do so. A special pricing model should be applied, based on the lowest substance prices that the generic substitute would result in. Dose pharmacies should be allowed to negotiate the purchase price. If it is not considered possible to implement the Inquiry’s main proposal, an alternative may be to draw up a separate list intended to be used for the substitution of automatedly dispensed pharmaceuticals.

The proposals for a new pricing model are expected to mean more savings for the public sector than at present. For the few dose dispensing players currently in the market, the proposals means that they would have the right to negotiate the purchase price for pharmaceuticals to be used for automated dose dispensing.

Orphan medicinal products

Orphan medicinal products are intended for patients with rare and serious illnesses and are defined as such under a special EU Regulation (141/2000/EC).

There are applications for inclusion in the Swedish reimbursement system for orphan medicinal products that have been approved by the Dental and Pharmaceutical Benefits Agency, but in some cases applications have been rejected because the cost was considered too high.

The Inquiry proposes that for certain pharmaceuticals that cannot be subsidised in the regular procedure, a possibility should be introduced to subsidise them under a special procedure. This would mean that the Dental and Pharmaceutical Benefits Agency, together with the county councils and the company concerned, would agree on more detailed terms for the subsidy decision.

For the Dental and Pharmaceutical Benefits Agency to take such an initiative, a pharmaceutical product must meet certain set criteria in terms of patient numbers, characteristics of the illness, long-term/lifelong treatment and lack of other relevant treatment.

Furthermore, the Agency’s decision would be linked to special terms. These would be, for example, follow-up requirements of various kinds, time limits, repayment due to lack of effect, renegotiation times for pricing and volume limits. The number of pharmaceutical products affected by the proposal is estimated to be only two to three per year.

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It is suggested that most of the proposals should enter into force on 1 July 2016. We will be following this closely.