A strong European industry should in future produce medicines that are urgently needed. These should be affordable and available throughout Europe.

On 25th November 2020, the European Commission published its pharmaceutical strategy, which added another building block to the basic framework of a European Health Union (see also DSV paper "Towards a Health Union", November 2020). The wide bundle of proposals should:

 

1. ensure access to essential, innovative and affordable medicines is promoted

2. strengthen the competitiveness of the European pharmaceutical industry

3. further develop the EU’s strategic autonomy

4. work towards more uniform standards and a level global playing field.

 

European pharmaceutical legislation is to be fundamentally revised and adapted for this purpose by the end of 2022.

Open requirements

The European Commission notes that industry today does not always invest in developing drugs that are urgently needed. There are still open requirements, especially in the field of orphan diseases and children's therapy as well as antimicrobial drugs. The demand for certain medicaments would sometimes not be met, but this would also be due to strategic corporate decisions made by the pharmaceutical industry. Moreover, the prices are too high for the healthcare systems in some countries.

Improving the innovation climate

The bureaucratic procedures surrounding drug approvals and product and patent protection will also be studied. Competition could be improved for generics or bio-similars. Industry would need a "stable and flexible regulatory environment" as well as improved access to health data, as will be provided in the future in the European Health Data governance.

Strategic autonomy

One of the lessons of the COVID-19 pandemic is that Europe needs to become more crisis-proof. This objective is at the heart of the first European Health Union package and it is also reflected in the pharmaceutical strategy. More obligations should be imposed on manufacturers with regard to their supply and transparency obligations in order to prevent bottlenecks and a "structured dialogue" should be initiated. One of its first tasks for the planned new authority for crisis preparedness and response (HERA) will be the field of antimicrobial resistance.

Global cooperation

The pharmaceutical industry is globally intertwined. It is only logical to work on the global stage to ensure that the product qualities are right, the production conditions are acceptable, undistorted competition is possible and the exchange of goods remains unhindered. The international cooperation between European Medicines Agency (EMA) and the network of national regulatory authorities has already begun. The aim here is to promote regulatory convergence.

The German Social Insurance ...

... welcomes the fact that the European Commission is focusing on the availability and affordability of medicines. It is right to want manufacturers to be more rigorous with regard to their reporting and delivery obligations. It is good that transparency on the research and development costs of pharmaceuticals is to be created - this can support price and reimbursement negotiations at national level. The bottom line is that the pharmaceutical strategy contains many positive aspects.

Other initiatives

Along with the pharmaceutical strategy, the European Commission has also published other initiatives:

 

1. An impact assessment on the revision of the regulatory framework covering medicines for children and rare diseases,

2. an intellectual property action plan to promote EU recovery and resilience and

3. the proposal for a data governance law, which will prepare the framework for sector-specific data governance such as the European Health Data governance.