Spain's AESEG warns new drug pricing decree fails to stop generic price erosion
The Spanish Association of Generic Medicines (AESEG) has warned that the draft Royal Decree on financing and price setting for medicines does not adequately address the progressive erosion of prices for generic, mature, essential or low‑price drugs. While the decree formally replaces the current reference price system, AESEG says it retains a logic of successive and cumulative price cuts without clear safeguards, and it omits an explicit cap on the initial reduction – the impact analysis mentions a 40 % cut but the text does not include it. The association fears this could discourage new product launches, reduce market entry, and jeopardise the commercial viability of certain medicines, the continuity of market operators and the security of supply. AESEG acknowledges some improvements, such as more dynamic market‑share quotas, but argues the main weakness – unchecked price erosion – remains uncorrected. Elena Casaus, AESEG’s general secretary, told Diariofarma, “It is a Royal Decree that does not correct the main criticism … the continuous erosion of prices to levels of commercial unviability.” The association has submitted an assessment document outlining these concerns.
Entities: Asociación Española de Medicamentos Genéricos (AESEG) · Elena Casaus · Royal Decree on financing and pricing of medicines · Spain · Spanish Ministry of Health
Claims
What the coverage asserts, and how well corroborated each claim is across sources.
- [○ 1 SOURCE] Elena Casaus, general secretary of AESEG, said the decree does not introduce corrective factors for very cheap prices that are eroding. (Elena Casaus)
- [● 3 SOURCES] The decree includes advances such as dynamic market‑share quotas but fails to correct the main weakness of price erosion. (AESEG)
- [● 3 SOURCES] The draft decree maintains a logic of successive and cumulative price reductions without clear safeguards. (AESEG)
- [● 3 SOURCES] The draft decree does not set an explicit maximum limit on the initial price cut; the impact analysis references a 40 % reduction but it is not incorporated into the text. (AESEG)
- [● 3 SOURCES] AESEG believes the omission could discourage new drug launches, reduce competitor entry, and weaken competition. (AESEG)
- [● 3 SOURCES] AESEG warned that the draft Royal Decree on financing and pricing of medicines does not sufficiently stop price erosion of generic, mature, essential, or low‑price medicines. (AESEG)
- [○ 1 SOURCE] AESEG submitted an assessment document highlighting the decree could lead to commercially unviable prices and affect supply security. (AESEG)
- [● 3 SOURCES] The current reference price system creates continuous pressure on prices that may compromise the economic viability of some medicines, market operator continuity, and supply security. (AESEG)