Medicines are crucial not only for improving our health and well-being, but also to fulfil our human right to health. But the price of many new patented medicines in Europe is growing higher every year, jeopardising the ability of patients to access them when needed and threatening the sustainability of our healthcare systems.

This situation is aggravated by a narrow interpretation of intellectual property (IP) rights that creates harmful monopolies. At the same time, it has been reported that new medicines and indications often offer little—or no—added therapeutic value over those that are already available. Added to this, the trend of accelerating market approval involves evaluating medicines on the basis of limited clinical data, leading to greater uncertainty about a therapy’s true effects.

HAI’s work in the EU can be broken down into three main areas:

• Equitable access to affordable medicines – Sustainable access to medicines and vaccines remains an issue in a number of EU Member States. The challenges of affordability and availability of medicines are linked to a research and development (R&D) model that incentivises innovation through monopoly rights (e.g., patent protection and other forms of market exclusivity), enabling high medicines prices.
• Medicines safety, added therapeutic value and rational use of medicines – The EU has a well-established medicines marketing authorisation system, but concerns remain about an often too permissive approach to efficacy requirements for medicines, and lack of consideration of added value.
• Democratisation of medicines policy – Good governance in the pharmaceutical sector is crucial to ensure that decisions are aligned with the public interest. Transparency and inclusiveness with patient and consumer groups are needed to generate trust, accountability and legitimacy. At the same time, robust policies on conflicts of interest are necessary to prevent private interests from being put ahead of the common good.

The HAI Europe Association and its Board provide content expertise on our annual workplan.