Locations
Draft Ministerial Order on the passing implementation of a system for the application of dual pricing in pharmacies for certain medicines for health and general interest reasonsl
On 8 July, the Ministry of Health submitted for public consultation the Draft Ministerial Order on the temporary implementation of a system for the application of dual pricing in pharmacies for certain medicines for health and general interest reasons.
There are currently supply problems for high-demand medicines that are included in the pharmaceutical benefits provided by the National Health System (SNS) but which can also be used for unauthorised and unfunded indications.
In view of this problem, it is considered necessary to implement a dual pricing system for these medicines, which preserves the availability of medicines for authorised uses. The proposed regulation therefore seeks to regulate a system for applying the reimbursements due as a result of the application of a system of prices notified in pharmacies.
Draft Order approving the authorisation procedure for establishments manufacturing and/or importing autovaccines for veterinary use
On 7 July, the Ministry of Health submitted for public consultation and information the Draft Order approving the procedure for authorising establishments manufacturing and/or importing autogenous vaccines for veterinary use.
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products introduces a legal framework directly applicable in all EU Member States, with the following main objectives:
- To improve the functioning of the market for veterinary medicinal products.
- Regulate key aspects such as the manufacture, import, export, supply, distribution, pharmacovigilance, control and use of these products.
- Ensure a high level of protection for public health, animal health and the environment.
In turn, in order to bring Spanish legislation into line with European regulations and to supplement them, the following exist in Spain:
- Royal Decree 1157/2021, of 28 December, regulating industrially manufactured veterinary medicinal products.
- Royal Decree 666/2023, of 18 July, which regulates the distribution, prescription, dispensing and use of veterinary medicinal products and includes, among other aspects, the conditions for the manufacture and use of veterinary autogenous vaccines.
In this regard, the purpose of this order is to regulate the procedure for authorising establishments that manufacture and import veterinary autogenous vaccines, in compliance with Royal Decree 666/2023.
Update on the status of the Royal Decree on Health Technology Assessment
According to the latest statements by César Hernández, Director General of the Ministry of Health's Pharmaceutical Portfolio, the new Royal Decree on Health Technology Assessment, which has been in the pipeline for almost a year, is expected to be published after the summer.
This Royal Decree aims to regulate the evaluation of health technologies (medicines, health products, in vitro diagnostic tests and other medical procedures) insofar as they are specifically intended to inform administrative decisions regarding the incorporation, financing, pricing, reimbursement or divestment of health technologies.