Spain's medicines and medical devices reform bill is sent to Parliament

The Council of Ministers on 21 July approved the referral to Parliament of a new bill that represents a comprehensive reform of the regulatory framework currently governed by Royal Legislative Decree 1/2015 of 24 July.

Spain's Medicines and Medical Devices Bill pursues three fundamental objectives: to guarantee equitable access to therapeutic innovation; to ensure the supply of critical medicines; and to strengthen the sustainability of the National Health System (NHS) through an independent evaluation model and more competitive pricing mechanisms.

Guaranteed supply

In order to prevent shortages, the bill introduces the concept of a "strategic medicine". This is defined as a medicine that is essential to the health system but whose supply chain is particularly vulnerable. It provides for the adoption of specific economic and regulatory measures designed to prevent shortages. Furthermore, in the context of public health emergencies, it strengthens the obligations on pharmaceutical companies, distributors and pharmacies to report stock levels.

New funding and pricing model

The bill redefines the pricing system around three main pillars. First, a dynamic pricing system is introduced for off-patent medicines, triggering automatic reductions in the manufacturer’s price once certain market share thresholds are reached. This complements the existing reference pricing system, although the two systems may not be applied simultaneously to the same medicine.

Second, a range of reimbursed prices is established within each homogeneous group. The NHS will cover the most cost-effective options in full, while patients may opt for a higher-priced brand by paying the difference themselves.

Third, conditional funding is regulated, allowing innovative medicines to be incorporated into the public healthcare system at an early stage, subject to outcome monitoring and with an obligation on the part of the pharmaceutical company to reimburse the NHS if the expected outcomes are not achieved or if the final price proves to be lower than the provisional one.

Prescription by nurses and physiotherapists

The right of nurses and physiotherapists to prescribe within their scope of practice is recognised. Within one year of the bill's entry into force, the regulatory framework will be updated to harmonise the prescribing practices of all authorised professionals.

Remote dispensing and home delivery

The bill incorporates alternative dispensing methods aimed at ensuring access to medicines in public health emergencies, as well as for patients whose clinical condition, degree of dependency, disability or particular vulnerability prevents them from travelling.

'Rational use'

The bill enshrines, for the first time, "rational use" as a guiding principle of pharmaceutical policy, establishing it as a shared responsibility amongst stakeholders in the sector. Its aim is to ensure that every patient receives the optimal treatment, at the appropriate dose and for the appropriate duration, at the lowest possible cost.

Osborne Clarke comment

The main stakeholders in the sector have welcomed the bill, although they are calling for improvements during the parliamentary process. In particular, the Spanish Association of Generic Medicines notes that the legislation may not fully resolve the structural pressure on the prices of generic medicines, nor is it fully aligned with the new European pharmaceutical policy.

The parliamentary process will repay close attention. The bill provides for the outright repeal of Royal Legislative Decree 1/2015 of 24 July, which will entail a substantial transformation of the regulatory framework applicable to the sector.  The amendments introduced during the process and the body of implementing regulations resulting from its final approval will together determine how the new framework operates in practice for companies across the medical supply chain.