Amendment of the Law on guarantees and use of medicines and medical devices

What are the new regulation's objectives and what are the problems it aims to solve?

The preliminary public consultation has opened on the draft bill amending Royal Legislative Decree 1/2015, of 24 July approving the consolidated text of the law on guarantees and rational use of medicines and medical devices (RDL 1/2015). This announced the intention to modify a reference regulation in the pharmaceutical sector to adapt it to the current regulatory, social-health, and economic context at a national and European level.

Regulatory background

The Spanish Law regulating medicines and medical devices dates back to 2006, specifically, the Law 29/2006 of July, on guarantees and rational use of medicines and medical devices. The successive amendments of this Law led to the approval in 2015, for the sake of clarity, of the RDL 1/2015, which is the regulation currently in force.

This reform proposal aims to adapt the current legislation to the scientific advances and new technologies that have arisen in recent times, as well as to the different European regulations approved in recent years regarding the products regulated by this law. 

Problems to solve

From the document published by the Ministry of Health it is possible to extract the main objectives of this new proposal, which will mainly focus on the following four driving forces:

• Public financing measures for medicines to rationalise pharmaceutical spending.
• Adapting Spanish legislation to European regulations and, in particular, to rules on clinical trials, medical devices, veterinary medicinal products and European jurisprudence on incentives for the development of orphan medicinal products.
• Adapting the National Health System to new disruptive scientific developments and the introduction of new technologies.
• Adapting regulations to the pandemic experience.

Timeliness of reform

The budgetary relevance of pharmaceutical spending in the NHS is the focus of the note published by the Ministry of Health, which is why the new regulation will essentially and predictably be focused on the financing of the NHS. 

Other aspects will cover the outdatedness of the legislation regarding the pending European reforms to which Spain's national legislation has not yet been adapted, such as Regulation (EU) 2021/2282 on health technology assessment. The purpose of the new Law will be to provide legal certainty and a new solid, transparent and predictable regulatory framework for medical devices and cosmetic products, promoting innovation and the harmonisation of rules for the introduction of medicinal products on the market. This will allow access to the free movement of goods while ensuring a high level of health protection for patients and users.

Objectives to be met 

The ministry headed by Carolina Darias intends, with the reform of RDL 1/2015, to implement various changes, including:

• Modify the pharmaceutical contribution system to achieve a better redistribution of the economic burden resulting from pharmaceutical co-payment.
• Modify the reference price system by introducing elements that increase competition and value inputs that provide incremental benefit in the use of medicines.
• Enable drug depots in social and healthcare facilities to be linked to primary care pharmacy services, in addition to hospital pharmacy services and pharmacies.
• Modify the system for calculating the four-monthly contribution made to the NHS by manufacturers, importers and suppliers of medicines and medical devices financed with public funds. Medicines dispensed in healthcare centres will be added to this calculation, and not only those dispensed in pharmacies.
• Clarify competences regarding the control of the advertising of medicinal products.
• Incorporate amendments to European regulations on medical devices, in vitro medical devices, veterinary medicinal products, and clinical trials of medicinal products for human use.
• Incorporate a separate chapter on guarantees for medical devices, cosmetics, and personal care products. 
• To amend the articles relating to the advertising of medical devices.
• Any other that is deemed necessary to achieve the overall objective.

Osborne Clarke comment

The Ministry of Health has ruled out not amending RDL 1/2015 as the problems to be solved, set out above, require a regulatory solution, and legislative inoperability would affect the health of the population, the sustainability of the NHS, and would prevent compliance with the European legislation. 

This is the beginning of a long legislative process that should culminate in the approval of a new law in the Spanish Parliament to improve the regulation of medicines and medical devices in Spain.