Proposals for innovation in accessing innovative medicinal products in the Spanish NHS

This week we presented the report ‘Proposals for innovation in accessing innovative medicinal products in the Spanish NHS’. This report is part of CEFI’s Access Observatory, which we have been working on for a year, in collaboration with six renowned experts in pharmaceutical law, who have carried out an in-depth analysis of the scope for improvement as regards access to innovative medicinal products.

At the presentation event, we held a debate structured around two round tables to enable a multidisciplinary view of access to innovation in Spain and to present the report.

Fernando Moreno Pedraz, President of the CEFI Foundation, and Carlos Martín Saborido, Advisor to the Ministry of Health’s Directorate General for the Common Portfolio of NHS Services and Pharmacy, took part in the opening ceremony.

Fernando Moreno gave a brief introduction, pointing out that the time from drug approval to access is still long despite the efforts made, and that there are significant discrepancies between different Autonomous Communities and hospitals. He explained the rationale behind the report and thanked the experts for their excellent work and for their assistance to the key players in this field who were with us.

Carlos Martín informed us of the changes that the Ministry is considering in terms of access, the most significant of which, in terms of financing and prices, is the Health Ministry asking laboratories for their economic evaluations, which will then be critically reviewed. This constitutes a further step towards the required procedural transparency. Carlos Martín also told us that transparency must be ensured in the processes of evaluating and negotiating prices and financing conditions for new medicinal products and that the Law on Guarantees (Ley de Garantías( will lay the general foundations required to make the necessary changes.

Laura Quintas Lorenzo, Vice-President of the Spanish Haemophilia Federation (FEDHEMO), called for patient participation in decision-making and emphasised equity of access, saying ‘we must not allow access to medicines to be dependant on where people live’.

Elena Casaus, Head of the Advanced Therapies Division of the Community of Madrid, also highlighted the Community of Madrid’s constant innovation to ensure access to advanced therapies.

Luis Verde, Manager of the University Hospital of A Coruña, told us about the experience at his hospital, now part of the Galician Health Service (SERGAS) hospital network, regarding the authorisation of medicinal products in special situations.

Enriqueta Felip, President of the Spanish Society of Medical Oncology, called for transparency in the entire process of evaluating and negotiating price and financing conditions for new medicinal products.

Jorge Mestre, Health Economist, spoke of the need for these financing systems to be dynamic and rigorous in order to evaluate cost and methodology, maintaining that evaluation and budgeting should be separated to avoid potential conflicts of interest.

There was also discussion on investment in innovation and the role of innovation in improving the lives of patients who need all the therapeutic options available as soon as possible.

During the second round table discussion, the main conclusions reached by the working group of six pharmaceutical law experts were presented.

Participants in this round table included Montserrat Llopart, partner at Baker & McKenzie; Paula González de Castejón, partner at DLA Piper; Raquel Ballesteros, partner at Simmons & Simmons; Lluis Alcover, partner at Faus Moliner and Joan Carles Bailach, lawyer at Faus Moliner. Juan Carlos Campo Moreno, Magistrate of the Constitutional Court and former Minister of Justice, acted as moderator.

As the main conclusion of the work carried out, the members of this working group agreed on the need for the NHS to have more flexible and transparent procedures for evaluating and pricing new medicinal products, which will allow pharmaceutical innovation to be made available to patients as soon as possible.

During her speech, Montserrat LLopart stated that ‘the current financing and pricing system contains inefficiencies that generate legal uncertainty for pharmaceutical companies, as new medicinal products are subject to a series of successive evaluations that delay the process.  For this reason, we believe that the new Law on Guarantees should clarify the entire evaluation process, as well as​ shorten the time between approval of the medicinal product’s price and its availability throughout the NHS, without the Autonomous Communities then conducting additional procedures for re-evaluating and re-validating those same medicinal products’.

Paula González de Castejón explained the analysis carried out on procedures followed in neighbouring countries and which aspects should be adopted within the Spanish framework. In this regard, González de Castejón insisted on the need to establish a clear procedure that avoids duplication ‘for which it is essential to limit the number of authorities and bodies involved’, with deadlines that are set and respected by all the bodies involved, ‘as we must not forget that every day counts when it comes to patient care’.

Raquel Ballesteros also commented on this area, insisting on the need to respect the limits imposed by Directive 89/105 for a single financing procedure lasting a maximum of 180 days. Ballesteros also explained one of the main proposals drawn up by this working group, to make the national evaluation procedure independent of the funding procedure ‘with the creation of an evaluating body independent of the funder, such as an evaluation agency, since it is precisely this independence that allows the discretion and presumed correctness of the technical evaluator’.

During his talk, the lawyer Joan Carles Bailach referred to an issue that is stirring debate: the confidentiality of laboratory sale prices (LSP) for medicinal products. In this respect, Bailach stated that ‘this confidentiality must be preserved in the public interest, as it is precisely this that allows Spain to access new treatments at lower prices than other European countries’. Bailach went on to say that ‘Maintaining LSP confidentiality is perfectly compatible with full transparency on the part of the Ministry of Health when it comes to incorporating new drugs into the NHS’.

Finally, the working group also made some proposals regarding access to non-financed drugs. Lluís Alcover referred to this aspect, talking about ‘the need to simplify access to medicinal products that have been authorised but not yet marketed, for example through a statement of compliance system under which the marketing authorisation holder can supply those treatments’. Alcover also pointed out that, in the group’s opinion, ‘the report on the public financing of medicinal products, which expressly resolves not to provide NHS funding, cannot be an obstacle to the acquisition of these drugs’.

The report ends with proposals for improvements and achieving more efficiency in communications and time frames in the various administrative procedures in the digital era, from the authorisation of an innovative medicinal product to its access by the patient. These proposals were made by Lourdes Fraguas Gadea, State Lawyer on leave of absence, who was unable to join us for the debate.

It was a fascinating debate that sought reflection on possible improvements to the process of accessing innovative medicinal products.

You can access the report and its key takeaways here:

https://cefi.es/categoria-producto/publicaciones/revista-cuadernos/

This post is also available in: Spanish