Ensuring access to innovative medicines for patients in smaller countries (Guest Blog)
Recently, during the Nordic–Baltic Health Summit, the Minister of Health of Latvia, Hosams Abu Meri, stated that “small countries will always be in a more challenging position due to their smaller markets and this is especially true when it comes to access to medicines.”
Ensuring equitable access to medicines has been one of the Minister’s main priorities, and important steps have already been taken at the national level. However, it is clear that more can still be done. As the European Union discusses new pharmaceutical legislation, Critical Medicines Act and other related regulations, there is significant momentum to reach historic agreements—not only within individual countries, but also across the EU.
Defining the Challenge
It is essential first to define what we mean by “access to medicines,” as the term encompasses multiple, sometimes divergent, issues—ranging from availability and affordability to timely patient access and reimbursement systems. It is also important to distinguish between challenges that can be addressed domestically and those best managed at the EU level.
Examining Latvia as a case study illustrates the challenge: only 18% of innovative medicines registered by the European Medicines Agency in the past four years are available to Latvian patients.[1]
For a medicine to become available to patients within the national reimbursement system, the manufacturer must first submit a reimbursement application at the national level. The Medicines Agency then evaluates whether the medicine is cost-effective. If the evaluation is positive, the medicine is added to a waiting list for state funding. At any given time, around 80 medicines are waiting on this list in Latvia. Often, it takes years between the positive assessment of the Medicines Agency and actual availability to patients within the reimbursement system. So the main obstacle to availability in Latvia is a lack of funding, which cannot be solved by EU measures.
EU-Level Actions for Small Countries
However, while much work is needed within national systems, several steps at the EU level could significantly improve access for patients in smaller member states:
- Fostering innovation: Medicines cannot be accessed unless they exist in the first place. The research and development process in the pharmaceutical sector is lengthy and costly—often exceeding a decade and requiring billions in investment. Recent breakthroughs have turned once-fatal diseases into manageable conditions, and innovation continues at an unprecedented pace. Every patient deserves access to the best available treatments. To this end, all EU countries must nurture an environment supportive of pharmaceutical innovation. Strong regulatory data protection and adequate market exclusivity are key incentives. Facilitating innovation in Europe means European patients, including those in smaller countries, benefit first.
- Flexible solutions over “one-size-fits-all” approaches: Due to the diversity among EU countries and even between small countries, standardised solutions are unlikely to address all obstacles to access. In exceptional situations—such as when a necessary medicine is not locally available—a structured dialogue between government and the manufacturer could be established as a concrete measure to facilitate timely patient access. EU regulation could enable and support such structured dialogues, provided there is sufficient flexibility to reflect each country’s distinct healthcare, epidemiological, and system needs. Such targeted measures would be faster and more responsive than, for example, joint procurement initiatives, which can be too rigid or slow to meet urgent patient needs.
- Ambitious funding for health: Smaller countries must coordinate to strongly advocate for robust health funding in the EU’s Multiannual Financial Framework. Expanded funding should support public health priorities, including improved patient access to innovative therapies across Europe. This is a genuine opportunity to coordinate efforts that can deliver real, tangible solutions to patients.
- Strengthening policy dialogue: Regular, open dialogue between policymakers and the pharmaceutical industry—both nationally and at the European level—is critical to designing effective solutions. Given the complexity and heavy regulation of pharmaceutical markets, it is essential that all stakeholders are involved. Such inclusive discussions allow for a holistic view of the challenges—and joint creation of sustainable solutions for the common aim.
Moving Forward
There is now momentum—at both national and EU levels—to make ambitious investments in health and innovation. We should seize this window of opportunity to ensure that all patients in Europe, regardless of country size, enjoy equal and timely access to the best available treatments.
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