What do you see as the EU pharmaceutical legislative package’s main priorities?
We are now in the final stage of a five-years journey that began in 2020 with the New Pharmaceutical Strategy for Europe, for which I had the privilege to be also the rapporteur for the Parliament. The GPL review must address unequal access, strengthen competitiveness, and ensure the economic sustainability of health systems.
The key priority is to find balance between a competitive “Made in Europe” pharmaceutical industry and wider and fairer access for all European citizens to the most innovative, safe and effective treatments, through innovators, generics and biosimilars, addressing unmet needs, and the growing threat of medicines shortages and antimicrobial resistance.
How will it reshape Europe’s pharmaceutical landscape?
The new pharmaceutical legislation must respond to the challenges of a completely different world than twenty years ago. The highly unstable geopolitical context and the wars on Europe's doorstep reinforce the lessons we have learned from the pandemic and the ensuing economic, political and social crises. Health is integral to Europe’s security and should be part of its defence strategy with adequate funding.
The Commission proposal introduces useful tools such as early notification of supply disruptions through prevention and mitigation plans
Boosting the global competitiveness of our "Made in Europe" pharmaceutical industry and fostering our security through resilient supply chains and the strategic autonomy of the European health sector is imperative. Digital transformation, AI and new advanced therapies, with genomics, will play a decisive role in the fight for innovation competitiveness between Europe, the United States and China.
We need to create a stable and predictable regulatory framework that attracts investment from all over the world and drives industrial prosperity without too much red tape and ensuring incentives for innovation and protection of intellectual property, which represent the key driver of research and development in the pharmaceutical sector.
Which measures in the reform can strengthen supply chains and improve early warning systems with community pharmacies regarding medicine shortages?
Medicine shortages remain a major challenge, and the GPL revision offers a chance to strengthen prevention and build a resilient distribution model from manufacturer to patient. We need to enhance prevention, monitoring, and cooperation at European level. The Commission proposal introduces useful tools such as early notification of supply disruptions through prevention and mitigation plans. I welcome the European Medicines Agency's (EMA) expanded role via the European Shortages Monitoring Platform (ESMP), but this must be matched with greater resources.
I also welcome the Commission proposal to allow for supply chain actors other than MAHs to report information regarding medicine shortages. Where pharmacy-reporting systems are available at national level, community pharmacies can contribute to the collection of relevant information for National Competent Authorities on shortages.
Member States should allow pharmacists to substitute medicines in short supply with suitable alternatives, in consultation with prescribers and patients
What role do you see for pharmacists in managing shortages locally, and is this reflected in the package?
I believe pharmacists can be key for an adequate preparedness, an effective prevention and a prompt response to medicine shortages at local level. First of all, Member States should allow pharmacists to substitute medicines in short supply with suitable alternatives, in consultation with prescribers and patients. Moreover, Member States should facilitate access when no alternatives exist, allowing pharmacies to prepare medicines according to prescriptions or pharmacopoeias.
This exemption, especially in Spain, enables access for patients to otherwise unavailable treatments. I can agree with the Commission on the need of harmonising this exemption at European level, preserving the originators’ industry right of market protection but we have also the responsibility of guaranteeing the broader possible access to medicines to all our patients. We must find the right legal balance to ensure access and market protection.
The reform proposes replacing paper leaflets with electronic product information. How can patients’ equal access and privacy be safeguarded, while ensuring digital tools complement printed versions instead of replacing them?
On this issue the negotiations are still going on. My position, which I have promoted since I was rapporteur for the New European Pharmaceutical in 2021, is to integrate a hybrid solution for the time being. Member States may decide to implement digital leaflets, together with paper leaflets, for multilingual access so that if I am in another country and need to take medication, I can access the medical information and understand what I am taking and what the effects are, to prevent allergy or intolerance. Patients’ right to a printed leaflet remains guaranteed.
For hospitals and other specific settings, like public tenders for which companies currently have to prepare a stock of medicines with information in the language of the country in which they are bidding, and if they do not win the tender, they destroy those medicines, which are then lost, digital leaflets might be an option. Over the next decade, as the digital divide narrows, we expect an increasing use of digital leaflets, but it is important to leave no one behind and that information collected from patients accessing digital leaflets is not used for commercial or discriminatory purposes
In our shared fight for reducing and stopping the antimicrobial resistance, mandatory prescriptions for antimicrobials remain a priority, with possible exceptions for minor topical infections
How will reforming pharmaceutical legislation help reduce antimicrobial resistance?
I really believe that the proposed measures to address medicines shortages will have a positive impact also on the continuous availability of antibiotics in Europe. Moreover, I fully support the proposed “awareness card” as a support for patients which pharmacists can use when informing patients on the prudent and correct use of antimicrobials, as well as their effective disposal. In our shared fight for reducing and stopping the antimicrobial resistance, mandatory prescriptions for antimicrobials remain a priority, with possible exceptions for minor topical infections.
Finally, regarding the new incentives proposed by the Commission to encourage the development of novel antimicrobials, I am aware that we don’t have yet the best possible solution. The complexity of the issue requires a deeper involvement, but we are running out of time, and we must start from some point. The proposal on the table is a starting point, a pilot which will give us new valid information to adjust the urgent measures needed, to really boost new investments on antimicrobials’ R&D.
What is your vision for pharmacists’ role in the reformed pharmaceutical system—as healthcare professionals and a bridge between patients and the medicines ecosystem?
Pharmacists are fundamental, trustful, and irreplaceable allies for our patients, for our National Health Systems and for the consolidation of the European Union of Health now and even more in the reformed pharmaceutical system. In Spain, almost every community—even small villages—has a pharmacy, often the only healthcare presence for miles.
Pharmacists gather real-world data on medicine use and outcomes, informing regulatory, research, and public health decisions. The European Health Data Space, under GDPR, should enable this integration and benefit all health systems.
Protect patient safety, privacy and inclusion. Keep paper medicine leaflets the default, with electronic information as a complementary option. Removing paper deepens the digital divide, shifts costs to patients and pharmacists, and reduce access to information
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