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.

Elsewhere in the European health sphere, the use of Artificial Intelligence (AI) has become dominated by an overly positive narrative pushed by the pharmaceutical companies and MedTech. In reality, major risks exist, including discrimination, harming people’s health and safety, exacerbating health inequalities, and infringing on patients’ fundamental rights.

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

• Equitable access to affordable medicines – Excessively high-priced medicines remain a challenge for the economic sustainability of European Union (EU) public health systems. Intellectual property-based monopolies constitute a serious obstacle to competition, hindering the ability of governments to reduce costs while denying citizens the freedom of choice of therapeutic alternatives. HAI promotes the use of TRIPS flexibilities and other health-sensitive intellectual property management tools as a means to tackle these issues. In 2023, we will also be working to improve the availability and uptake of diagnostics to support responsible prescribing and stewardship of antibiotics as a means to tackle the ever-growing threat of antimicrobial resistance (AMR).
• Artificial Intelligence and Health – Currently, no harmonised standards or laws exist that specifically regulate AI-assisted medical devices and other health AI, while such devices are already being developed and used. The EU’s AI Act provides an opportunity to change this. However, current regulatory provisions in the Act fall short in protecting patients’ rights. What is needed are solid regulatory requirements in legal frameworks for health AI, which take into account the risks for health and fundamental rights violations.
• Democratisation of medicines policy – Increased accountability is key to ensuring public trust in EU institutions. Yet, issues or policy proposals relevant to access to medicines are often discussed with little scrutiny or accountability. Civil society therefore holds a vital role in scrutinising the work of the EU institutions, regulatory authorities and national governments. But patient, consumer and healthcare professional groups need capacity and expertise if they are to engage fully in the medicines policy debate and contribute to overall health outcomes of policy decisions.

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

This webpage was produced with the financial support of the European Union. Its contents are the sole responsibility of Health Action International and do not necessarily reflect the views of the European Union.