The Spanish Government has just approved the Annual Regulatory Plan for 2023, which sets out the legislative and regulatory initiatives that the various Ministries, including the Ministry of Health, plan to submit to the Council of Ministers for approval during this year. The Ministry of Health plans to propose three laws and three regulations, highlighting the following:

Law amending the revised text on guarantees and rational use of medicinal products and medical devices

The aim of the amending law is to bring the current text up to date with European and international requirements and developments in the field of human and veterinary medicinal products, medical devices, cosmetics, biocides for personal use and personal care products. It also aims to introduce modifications and incorporate new perspectives related to public reimbursement of medicinal products.

Royal Decree on pricing and reimbursement of medicinal products and medical devices

The regulation aims to develop the following aspects, among others:

• inclusion of medicinal products and new indications for medicinal products in the so-called pharmaceutical provision of the National Health System (NHS);

• special conditions for reimbursement of medicinal products;

• special medicinal products pricing regimes;

• industrial price review regime for medicinal products;

• exclusion of medicinal products from the pharmaceutical provision of the NHS;

• reimbursement of medicinal products available under early access programs; or

• inclusion of medical devices in the pharmaceutical provision of the NHS.

Royal Decree on Health Technology Assessment

It aims to regulate an independent, transparent and collaborative system for the evaluation of the therapeutic positioning of health technologies through an evidence-based scientific process to determine the relative efficacy and efficiency of technologies, including the involvement of different actors in this assessment (e.g., lay members representing the interests of patients). It also aims to develop those aspects that are not covered by the Health Technology Assessment (HTA) Regulation.

In addition, the authorities are currently reviewing regulations on early access and on advertising of medicinal products and medical devices.

Next steps

We encourage the pharmaceutical industry to follow these initiatives closely and to participate as much as possible in their development – it is essential to gradually become familiar with the regulatory changes that are taking place, not only to contribute to their development and correct implementation, but also to anticipate and start thinking about adjusting processes and strategies.

We routinely advise clients on these, and other, complex challenges in the pharmaceutical industry. Please contact the author or the Hogan Lovells attorneys with whom you regularly work for questions regarding your specific medicinal product needs.