Pharmaceutical reform must deliver patient access

A proper reform of the European Union’s legislation concerning the pharmaceutical sector has been long overdue. In fact, the current legislation is over 20 years old, which explains why the pharmaceutical sector has welcomed the recent announcement of a major agreement to update the regulatory framework. This will strengthen competitiveness and innovation while keeping strict safety standards in place.

For countries like Malta, where access to medicines remains a major challenge, the new legislation is a major milestone because it streamlines procedures to speed up supply chains and help bring new medicines to our market more quickly.

Additionally, stronger incentives will encourage the creation of new products whereas the problem of medicine shortages will be tackled through better monitoring and coordination and clearer patent exemptions that support timely entry of generics.

From a legislative perspective, the announced reform is truly ambitious. However, its success will also greatly depend on a committed approach by all stakeholders, namely policymakers, regulators and the industry at large to implement this legislation in a uniform manner across all the EU member states.

For smaller countries like Malta, failure to do this will certainly lead to more negative repercussions. Regular studies have constantly confirmed a huge disparity in access to new treatments across European countries where patients in larger member states tend to enjoy access to medicines months and, in some cases, years ahead of patients in the EU’s periphery.

These delays are often caused by fragmented pricing systems, administrative bottlenecks and commercially driven decisions where higher-volume markets tend to be prioritised.

The huge gaps that exist are not only unfair. They also go against the EU’s aspiration for more cohesion between members. Most importantly, these gaps might not always have been politically acknowledged, however, as healthcare professionals, we know how deeply felt they are by patients.

Having operated in the pharmaceutical sector for over 70 years, healthcare company Vivian witnesses the effects of these disparities every day. And, for those patients battling with more rare diseases and conditions, regulatory delays mean negative impacts on their dignity and a right to better quality of life.

This long-overdue pledge for reform of pharmaceutical legislation is not only a promise to redress the balance. It is a win for all patients struggling to access better medicines when they need them most. It is also a win for companies like ours, which, for many years, have been advocating for equitable access to medicine.

Legislation may be sophisticated but this will not be enough because different countries experience different realities and the needs of their patients vary. This is why legislation will need to be implemented through a disciplined collaborative effort that acknowledges the fact that equitable access goes beyond ethical aspiration.

This notion is perhaps best represented by PATH – Promoting Access to Treatments & Healthcare – an international think tank which seeks to propose practical solutions to advance medical access across Europe, whose work focuses on accelerating availability of treatments, ensuring fair and timely access irrespective of market size and strengthening the resilience of supply chains.

These priorities might, at face value, seem aligned with the EU reform’s objectives, however, the reality goes beyond legislation.

Globally, rare diseases and paediatric populations, for instance, continue to suffer from a lack of structural investment. This is where Europe must ensure that regulatory efficiency is not trumped by commercial viability. Similarly, smaller member states will be better served by ensuring more transparency, regulatory responsiveness and cross-border cooperation among national authorities.

Another crucial aspect is ensuring a resilient supply and availability of medicine. European patients remain vulnerable to disruptions beyond Europe’s control. Therefore, while the EU’s intentions may be clear enough, Europe needs to reclaim its lost strategic autonomy.

Only a combined effort from private operators and national systems to ensure diversified production, improved forecasting and a more strategic approach to stock management can make this possible.

Whether Europe can convert its legislative efforts into measurable improvements is yet to be seen. However, as for pharma companies like ours, our drive should go beyond compliance. We must deeply commit to the underlying principles of this announced reform through continued investment in quality systems, by maintaining rigorous compliance standards and by actively pushing the interests of patients, especially in Malta, where our patients deserve equal access to that of any citizen in Europe.

Europe’s pledge to reforming pharmaceutical legislation is a positive start. But the real test will be to translate policy into real and tangible benefits for patients.

There is only one solution: as it legislates, Europe must embrace the true spirit of collective responsibility and commitment to citizens who most depend on its healthcare systems.

Corinne Zaffarese Elbourne is regulatory affairs and quality unit manager at pharma and well-being company Vivian.