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CNMC Report on the Draft Law on Medicines and Medical Devices
Last week, the CNMC published its report on the Draft Law on Medicines and Medical Devices. The overall assessment is positive, highlighting that the reform of the reference price system and the greater role of patients in choosing medicines (avoidable co-payment) were previous recommendations of the CNMC. No specific risks are identified.
The following improvements are proposed:
- Reassess the exclusivity of pharmacies to sell non-prescription medicines online and allow the distance sale of non-prescription healthcare products when the necessary guarantees are in place.
- Greater justification is requested for restrictions and infringements in the area of advertising, and exceptions for public health campaigns.
- It is suggested that the current regime prohibiting vertical integration between different agents be made more flexible.
- It is proposed to reduce discretion in the authorisation of medicines, establish deadlines for decisions, and allow errors to be corrected or information in applications to be completed. The requirement for licences for certain healthcare products is also questioned and, in any case, it is recommended that the procedure for obtaining them be simplified.
- It is recommended that administrative duplication in the evaluation of health technologies be avoided and that decisions that deviate from the scientific report be adequately justified.
- It is proposed to strengthen the publicity and transparency of financing agreements, while respecting the confidentiality of commercially sensitive information.
- It is recommended that intervention outside the provision of the SNS be better specified and justified, and that factors other than price be considered when setting distribution margins. It is also proposed to introduce a clawback mechanism for discounts in the distribution chain and to carry out continuous therapeutic and economic evaluation of innovative medicines, taking advantage of the potential of new technologies.
- It is requested that transparency and legal certainty in the classification of companies in the Profarma programme be strengthened and that the CNMC guidelines on public procurement be followed.
The Ministry of Health and the FEMP publish a guide to transforming public spaces with urban planning measures that improve health
Last week, the Ministry of Health, in coordination with the Spanish Federation of Municipalities and Provinces (FEMP), the Ministry of Transport and Sustainable Mobility, and the Ministry of Housing and Urban Agenda, published the guide: ‘Act and transform! Tactical urban planning to improve health in the local environment.’
- The document provides local councils with accessible, low-cost proposals for transforming urban environments into healthier, safer and more inclusive spaces.
- It offers practical resources to promote active mobility, reduce environmental pollution and improve coexistence in public spaces.
- It presents examples of actions to be carried out, such as bike lanes.
- The guide incorporates a public health perspective by addressing the social factors that influence it, through solutions that contribute to reducing inequalities and improving quality of life.
Draft Royal Decree regulating the recognition and control of the right to health protection and healthcare funded by public funds, in accordance with Royal Decree-Law 7/2018, of 27 July, on universal access to the National Health System.
On 12 July, the Ministry of Health submitted for public consultation the Draft Royal Decree regulating the recognition and control of the right to health protection and healthcare funded by public funds in accordance with Royal Decree-Law 7/2018 of 27 July on universal access to the National Health System.
The main objectives of this regulation are
- To establish regulations on how to recognise and monitor the right to health protection and healthcare.
- To establish a method for recognising and controlling the right to healthcare that promotes access to it, standardises it and simplifies it in accordance with the provisions of Royal Decree-Law 7/2018 of 27 July.
The deadline for contributions is 28 July 2025.