Table of Contents
The qualitative healthcare system and patient safety need constantly improving regulatory mechanisms.
Some say, “2022 is probably the biggest year in EU Pharmaceutical law”. Besides that, the pharma industry is responding to a large extent for the successful establishment of better healthcare and improved patient safety. It needs a secure and transparent regulatory mechanism as one of the most progressively developing fields. Moreover, such a mechanism has to evolve and adapt to emerging market trends and threats.
Readiness for Regulatory Reform
As recent research discovered, the Pharmaceuticals in the EU region are ready for a regulatory reform that will address market access to affordable medicines and reimbursement issues. In 2022, the European Union’s pharmaceutical legislation was up for review for the first time in several decades. Numerous vital aspects could be affected, from cost to intellectual property rights. However, the highlighted crucial areas of a potential legislative change are the following:
- Conditionality of Intellectual Property
- Market exclusivity Reduction
The bond which unites these three is the unmet medical needs. The process started in 2020 with the adopted Pharmaceutical Strategy for Europe. The document aimed to create a future-proof regulatory framework, supporting the technology development in the sector and addressing the market failures. However, there is no concrete timescale because this is a massive step for EU law. Furthermore, it is accompanied by many discussions with stakeholders till the “covenant” acceptance.
For a long time, the end user is not just a patient – it has become an essential part of the pharma cycle. The patients must be part of the process from medication’s early development through the regulatory process, monitoring, distribution, and daily use.
The patient’s voice is vital because it provides feedback firsthand. The opinion of one actual user of medicines could give much more helpful information about unmet needs, goals, and wants. With this in hand, Pharma companies would develop patient-relevant outcomes, subsequently creating outcomes for the industry.
Undoubtedly, the accuracy of the submitted information by the patients is always on point. The solution to this challenge is the use of real-world data and evidence. This requires a strong collaboration between the patient communities, regulators, data providers, and the pharma industry. Regarding this, patient-engagement frameworks for real-world data have already been developed. For example, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) now routinely consider the patient’s voice during their regulatory considerations.