European Parliament gives support to pharmaceutical strategy for Europe
The European Parliament gave its support to the pharmaceutical strategy for Europe, by resolution on November 24, 2021. Two main driving forces behind this strategy, adopted by the European Commission on November 25, 2020, are to support industry in promoting research and to address certain market failures. The aim is to create a regulatory framework for the future.
1. A pharmaceutical strategy for Europe
Both the content of the strategy adopted by the European Commission and particularly its implementation involve a complex process. The strategy is based on the following four pillars, which include legislative and non-legislative action:
Ensuring access to affordable medicines for patients and addressing unmet medical needs.
Supporting competitiveness, innovation and sustainability of the European Union’s pharmaceutical industry and the development of high quality, safe, effective and greener medicines.
Enhancing crisis preparedness and response mechanisms, diversified and secure supply chains, and addressing medicines shortages.
Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.
The strategy has involved adoption of the following key initiatives:
1.1 On access to medicines
1.1.1 Pilot project "Market Launch of Centrally Authorized Products"
1.1.2 Orphan and pediatric medicines. Based on the outcome of the evaluation of orphan and pediatric medicines published on August 11, 2020, which noted the existence of unwanted effects and recommended a review several elements of the legislation, and in line with the strategy adopted by the Commission, this institution (i) has put forward a number of alternatives for reforming the applicable legislation in this field, and (ii) launched a public consultation on the subject.
1.1.3 Proposal for a Regulation of the European Parliament and of the Council on health technology. On January 31, 2018, the European Commission adopted a proposal for a regulation on health technology, aimed primarily at strengthening cooperation between member states. In June 2021, the Council and the European Parliament reached a political agreement on the proposal, although it has yet to be adopted formally, under the applicable legislation.
1.2 On competitiveness and legislation
1.2.1 Revision of the EU’s general pharmaceutical legislation. This is probably the most emblematic action of the strategy and is planned for the end of 2022. It is currently in public consultation process until December 21, 2021.
1.2.2 Health Data Space for the European Union. The creation of a European Data Space, which includes the health sector, is one of the Commission’s priorities for the 2019-2025 period. A common European Health Data Space will promote better exchange and access to different types of health data, not only to support healthcare delivery (primary use of data), but also for health research and health policy making purposes (secondary use of data), and all of this must be in line with the applicable data protection law.
1.3 On the resilience of the system
1.3.1 Structured dialog on security of medicines supply. The purpose of this dialog is to strengthen the resilience of pharmaceutical supply chains and ensure the security of supply without compromising the affordability of medicines.
2. The European Parliament resolution
In its resolution, the European Parliament states that, for the pharmaceutical strategy to be fully effective it must incorporate lessons learnt from the COVID-19 crisis and that the strategy must revolve around the following themes:
Putting patients at the center of all health policies. It stresses the geostrategic imperative for the Union to regain its independence with regard to healthcare and its need for a diversified supply chain.
The serious threat posed by antimicrobial resistance to public health is underlined.
In relation to innovation, the Commission is called on, in dialog with the member states, to work on a framework for pharmaceutical legislation and a reimbursement system that favors meaningful innovation for patients and incentivizes fewer “me-too” pharmaceuticals which have no added value.
Measures are called for to increase transparency in the area of research into, and the development and production of, medicinal products, along with greater pricing transparency, and periodical evaluations and reviews of the incentive system.
It highlights the importance of generic, biosimilar and value added medicines for increasing equitable access for patients and making healthcare systems sustainable in the European Union and calls on the Commission to harmonize the interpretation at EU level of the Bolar provision.
There is a need to understand the root causes of the delayed arrival of medicines on the market, and to look into the huge differences across the EU of the average number of days between the approval of a medicine and the moment it becomes available to patients.
The launch of the incubator of the European Health Emergency Preparedness and Response Authority (HERA) is welcomed.
It calls for policy options to be looked into that will help guarantee that centrally authorized medicines are marketed in all member states and welcomes a review of pharmaceutical legislation to promote robust and fair competition, to support a stabilizing and balancing of national drug pricing systems, to promote fair national drug pricing systems and to ensure equal access to medicines and medical products across the member states.
Support is given to the various initiatives included in the strategy on the need to optimize and modernize the existing regulatory framework, and a call is made for the creation of financial incentives to preserve and expand the EU’s pharmaceutical industrial base.
The Commission is encouraged, in cooperation with the European Medicines Agency, to consider how established tools such as accelerated authorization, early dialog, the PRIME scheme and expanded guidance can be used to make medicine available to patients at a faster pace, especially medicines that have the potential to address an urgent public health threat or an unmet medical need.
It expresses a belief that a balance should be struck between encouraging innovation through the exclusionary effect of patents and ensuring access to medicines and protecting public health.