特許切れ医薬品（ジェネリックとバイオシミラー）の薬局における価格設定と競争についての制度比較。スペインの研究者により実施されたもので、スペイン以外については文献調査が行われた。その結果、主に、スペインとスウェーデンとについて、以下の項目が比較されており、両国に関する詳細なデータは参考となる。
スペインとスウェーデンにおける特許切れ医薬品の競争による処方薬小売の価格設定と償還制度のパラメータ
- 交換グループExchange groups：定義
- 処方と調剤 ：処方政策、薬剤師による代替調剤、患者の選択権
- 工場出荷価格の設定 ：最初のジェネリック参入時、毎月の改定（入札）、価格上限、最低価格、値上げ
- 流通チェーンにおけるマージン ：薬局と販売業者の所有権、販売業者と薬局の正式な手数料またはマージン、割引（値引き）、クロウバック、
- セーフガード：欠品を避けるためのセーフガード
ニュースソース
David Epstein（Department of Applied Economics, University of Granada, Granada, Spain）: Pricing and reimbursement of off-patent medicines dispensed in community pharmacies.
Gac Sanit. 2025 Jul 9:102506. doi: 10.1016/j.gaceta.2025.102506. Online ahead of print.
DOI: 10.1016/j.gaceta.2025.102506（フリーアクセス）
Table 1. Parameters of the pricing and reimbursement systems for retail prescription medicines with generic competition in Spain and Sweden.
| Spain | Sweden | Comment | |
|---|---|---|---|
| Exchange groups | |||
| Definition of exchange groups | Identical for active ingredient, dose, mode of administration, pharmaceutical form and pack size | Identical for active ingredient, dose and mode of administration | In Sweden, some variation is allowed between medicines in the same exchange group |
| Prescription and dispensation | |||
| Prescription | By commercial name or active ingredient, practice varies between regions. The physician can oppose substitution in case of medical need | By commercial name (original or generic). The physician can oppose substitution in case of medical need | Prescription policy in Spain varies between regions |
| Substitution by the pharmacist | Substitutes the lowest price medicine when prescription is by active ingredient | Substitutes the lowest price medicine (product-of-the-month) or a reserve product if the PoM is not in stock | A similar principle applies in both countries |
| Patient choice | Very limited choice in practice | Can choose a higher priced medicine and pay the difference | In Sweden, the patient has the option to choose a higher priced medicine and pay the difference |
| Setting ex-factory prices | |||
| On entry of the first generic | 40% price reduction required. The original must match this price | Price cap applies. Prices cannot increase higher than the highest price medicine | Price cap applies in Sweden, but there is no minimum price reduction |
| Each month | Manufacturer can propose a voluntary price reduction. Other firms can match this price, and must match the price within 3 months | Tendering system. TLV select the lowest-priced bid as product-of-the-month | In Sweden, prices can increase or decrease within limits, and differences in prices are permitted |
| Price caps | Once a year, there is a price review of all prices in the RPS. All medicines are obliged to match the lowest cost-per-dose-per day for that active ingredient across all exchange groups that include that active ingredient | Prices cannot increase higher than the highest price medicine. Once generic competition has been ongoing for at least six months, and the prices in an exchange group have dropped by at least 70 per cent, maximum prices are set at 35% of the pre-competition price | Price caps apply in both Spain and Sweden. However, there is more flexibility for prices to rise or fall in Sweden |
| Minimum prices | €1.60 per pack | 15 SEK (€1.34) | Similar principles apply |
| Price increases | Price increases can be requested in special circumstances, but the process is laborious | Prices can increase or decrease (within limits) | In Spain, prices can increase only in special circumstances |
| Margins in the distribution chain | |||
| Ownership of pharmacies and distributors | Private ownership. Distributors are often collectives run by pharmacies | 67% of pharmacies are privately owned, 33% publicly owned. There are no wholesalers | Some pharmacies are publicly owned in Sweden |
| Official fee or margin of the distributor and pharmacy | Fee increases with the retail price, up to a limit | Fee increases with the retail price, up to a limit | Similar principles apply |
| Discounts | Pharmacies can negotiate discounts | The margin for dispensing is regulated by law.Retailers cannot negotiate discounts with manufacturers (see Supplementary Material) | Discounts are, in principle, regulated in both countries |
| Clawback | Pharmacies are subject to clawbacks on turnover | No clawbacks are applied to pharmacies | Sweden controls overall expenditure by price regulation and competition rather than clawbacks |
| Safeguards | |||
| Safeguards to avoid shortages | Minimum price per pack. Manufacturer can request a price increase in exceptional circumstances | Minimum price per pack. Bidders in the tendering process must show they can supply the market during the month. TLV also appoints two back-up products | |
PoM: product of the month; RPS: reference price system; SEK: Swedish Krona; TLV: Sweden Dental and Pharmaceutical Benefits Agency.
2025年7月15日