Of Stefan Oelrich

As Europe is called upon to manage the ever -changing landscape of pharmaceutical regulation and innovation, recent discussions on European pharmaceutical legislation highlight the urgent need for a coherent strategy. The divergence between the conclusions of the EU Ministers Council and the European Commission’s original proposal highlights a decisive moment for the pharmaceutical industry, where finding a balance between the formation of political consensus and the urgent need to safeguard Europe’s future as a worldwide node.

The Council’s agreement on the EU’s package on medicinal products is a positive development in relation to the original proposal. Basic changes, such as the revised regulatory data protection provisions and the more limited and conditional approach to incentives associated with unfulfilled medical needs, reflect a wider challenge: How can balance between access and innovation be achieved within a single legislative framework. Although these adaptations recognize political realities, they at the same time reveal the restrictions of the effort to address complex issues through fragmentary policies.

In a rapidly changing global environment, Europe has to adopt a more ambitious approach to secure its position as a leader in pharmaceutical innovation. Although the existing legislative framework is a step forward, it does not respond to the vision required for the long -term shielding of Europe’s pharmaceutical ecosystem. The industry is ready to work with its institutions, Member States and other partners, so that the final package of measures not only meet today’s needs, but will also support Europe’s strategic autonomy in health and economy for the coming decades. Through the removal of obstacles and dealing with delays in access, in cooperation with the Member States, we can co -ordinate solutions that will ensure faster and fairer access to medicines for all European citizens.

At the same time, discussions on US duties and potential protective measures raise concerns about the impact on EU global trade relations. Interconnecting the pharmaceutical chain means that the import of duties could prevent patients from accessing the patients and resurrection. Open and rules based on global trade is a cornerstone of Europe’s power in the bioe science, and any measures that undermine this could have serious consequences for patient care on both sides of the Atlantic.

As warnings are increasing that Europe is losing ground compared to the US and China in the field of pharmaceutical competitiveness, the need for a holistic strategy becomes imperative. In the last two decades, its share of global investment in research & growth is reduced by 25% and a significant decline in clinical trial activity. The reasons are clear: lack of coherent industrial policy, increasing regulatory uncertainty and inadequate investment in its regulatory infrastructure. In order to reverse this trend, Europe must attract pioneering minds that innovate, talents and investment in research and production, accelerate the conversion of scientific excellence into therapeutic solutions and co -ordinate a framework that will ensure faster and fairer access to Europeans.

The revised European pharmaceutical legislation, although including some improvements, is not sufficient to bring Europe back to the avant -garde of biopharmaceutical innovation. A viable market for innovation must be created, recognizing that health investments are vital to economic safety. Strengthening the protection of intellectual property to align with the standards of in favor of innovation is decisive, as is the harmonization of approvals clinical trials across Europe. At the same time, the creation of a dynamic funding ecosystem for small and medium -sized enterprises in the field of biotechnology and bi sciences new impetus in the industry.

On the Bayer side, the regulatory framework must be modernized to keep up with innovation. The simplification of procedures in the European Medicines Agency and the removal of obstacles within the single market are critical steps to create a more efficient and predictable environment for pharmaceutical companies. In addition, the enhancement of a climate -friendly climate is vital to the financing of biopathic innovation. We support reforms, such as those in the capital markets, that will make Europe more attractive to pumping capital and the development of innovative businesses in the bio -science.

Greece, in particular, presents both challenges and opportunities for investment in the drug industry. The country has scientific potential and capabilities that can substantially contribute to the European Ecosystem of Bio Sciences. However, the viability of the health system and the effects of austerity measures place significant obstacles. Years of low public health funding, coupled with the highest levels of compulsory discounts and clawbacks in Europe, have formed a difficult environment for pharmaceutical companies.

In order to exploit Greece’s potential, bold political action that supports innovation, ensure more sustainable funding in the pharmaceutical sector and creating a stable, predictable business environment. This includes the modernization of access and compensation systems, the review of returning mechanisms and the introduction of new cooperation models between the public and the private sector – in particular in the fields of research and development (R&D), as well as production.
Europe is at a crucial crossroads of its pharmaceutical course. The decisions that will be taken today will form the role of Epirus in global health for years to come. A cooperative approach, supported by a strong regulatory framework and strategic investment, is essential to enhancing innovation and ensuring that patients’ access to lives that save lives. As other parts of the world move quickly, Europe must act decisively and immediately: to attract investment, to turn these investment into new treatments and to ensure that citizens in all Member States will have access to them. Adopting a bold vision for the future, Europe can regain its position as a world leader in pharmaceutical innovation and health durability – for the benefit of not only its citizens but also the international community.

* Stefan Oelrich is President of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Member of the Board of Management of Bayer AG & President Pharmaceuticals