Zug, Switzerland & Egham, UK – 22 May 2023 – Essential Pharma, an international specialty pharma group focused on ensuring that patients have sustainable access to low-volume, clinically well-established pharmaceutical products across key therapeutic areas, announces

On 26 April, the European Commission (EC) published proposals for its first major overhaul of the EU Medicines Regulatory Framework in 20 years.

We welcome the proposals and are pleased that they include discussion of medicine shortages and how to prevent them. Ensuring continued, uninterrupted supply is critical for patient care. This is particularly important in the case of low-volume or difficult-to-manufacture medicines.

At Essential Pharma, our goal is to improve patients’ lives by reinvigorating and ensuring the long-term, cost-effective and sustainable supply of such essential medicines. Our standard practices already reflect many of the EC proposals for additional requirements, for example daily inventory monitoring, long term planning, risk management and scenario modelling to anticipate shortages of medicines across the EU are all measures we have in place. In addition, the vast majority of Essential Pharma’s manufacturing partners that serve European patients are located in Europe, which minimises transportation lead-times and risks and we generally hold inventory at a higher level than the industry average. We have taken these decisions in the interests of patients and believe these measures are essential for ensuring continued product supply to the patients who are reliant on them.

The EC and all healthcare systems around the world recognise that maintaining product supply is not simple, particularly when we are dealing, as we at Essential Pharma often are, with niche formulations and presentations that are only used by relatively small patient groups. Implementing and managing some of the proposals the EC references, many of which we do already, costs time and money. We welcome these initiatives, which should be beneficial for EU patients and healthcare systems, provided there is an ongoing understanding of the costs of such additional requirements and regulations. We encourage the EC to simultaneously consider how its proposals would be funded. Without that simultaneous focus, we know that when the costs of doing business are increased without an ability for those costs to be recovered, product discontinuations will become more likely – something we all want to avoid.

The industry, healthcare systems, payers and regulators need open and regular discussion on supply issues, so that we collaboratively address how any cost increases are managed across all stakeholders; pharmaceutical companies alone will not be able to solve the problem.

These new proposals are right to focus on patients who need uninterrupted medicine supply. Let’s all work together – industry, government, regulators, healthcare professionals – to ensure that sustainable supply to patients at a fair price remains the focus.