European Health Union’s Pharmaceutical Legislation Reform for the Affordable, Accessible, and Innovative Medicines

For many years, EU countries have had problems accessing medicines on different issues. One of these problems is that current drugs are not affordable and accessible to everyone. Today, drugs are very important for the prevention, diagnosis, and treatment of diseases as a field where they are used frequently. For this reason, Europe's pharmaceutical industry occupies an important area of the EU economy in terms of product creation and innovation investment when viewed from a broad perspective.

With the development of the world and the advancement of technology within the scope of this development, these innovations are also reflected in the pharmaceutical industry. In this context, there are drugs that provide new treatments for different diseases every day, and these drugs offer new opportunities to patients. Although developments are like this, all these new drugs do not reach patients in EU countries at the same speed, and some patients are deprived of their use due to many different reasons. The whole world has seen one of the negative examples of patients' inability to access medicines during the COVID-19 pandemic. Everyone has seen the importance of having a healthy system and having access to medicines under all circumstances, especially in times of crisis that concern all countries of the world.

In this context, the European Health Union has started to carry out studies to make medicines accessible, affordable, and innovative for everyone by 2023. The Commission will try to improve the legislation by eliminating the existing deficiencies in line with the biggest reform they will make to date in the current EU drug legislation, which has been in use for about 20 years. The revision to be made in this direction will also make medicines more accessible and usable for people. In terms of the market, this revision will also increase the competitiveness among companies already in the pharmaceutical industry. For this reason, as a result of all these studies, it is aimed to modernize the pharmaceutical industry again with a patient-centered approach that also supports an innovative and competitive industry.

The areas to be regulated by the pharmaceutical sector reform can be listed as follows:

1.     A single market will be created for drugs.

2.     Medications will be delivered to patients faster and administrative burden will be reduced.

3.     Patients will be provided with equal access to medicines.

4.     Drug shortage will be eliminated and supply balance will be ensured.

5.     An innovative and competitive sector will be promoted.

6.     Medicines will be made more environmentally sustainable.

7.     Tackling antimicrobial resistance (AMR).

8.     Public funding for drug development will become more transparent.

Competitive industry promotion:

One of the most interesting topics regarding the regulations made is that an innovative and competitive sector will be encouraged. Within the scope of this reform, it is aimed to provide an innovation-friendly environment for the development and production of medicines. By establishing this environment, the EU will both ensure the production and development of innovative pharmaceuticals and increase its competitiveness in the market economy. While providing all this, it is aimed to authorize drugs more quickly at the end of the process by enabling more patients to participate in the drug evaluation process, along with simpler rules and procedures. For the establishment of this whole system, the European Commission also proposes to prepare a directive that includes issues such as authorization, labeling, protection of drugs, and their supply to the national and international markets.

Key elements of the reform:

• Innovative and affordable medicines for national health systems: The reform primarily aims to ensure that all patients have equal access to existing and newly manufactured medicines. With the new incentives, pharmaceutical companies will be able to develop drugs that are more accessible to patients in all EU countries. Public funding to encourage drug development will also be more transparent and data will be generated.
• Promoting the competitive market with innovation: The reform mainly covers the production of new drugs and the development of the ingredients of existing drugs. The European Medicines Agency (EMA) will provide support to developers of "one-size-fits-all'" to assist companies to facilitate faster approval and market launch of drugs. For example, while a normal authorization procedure takes more than 400 days, this will take 180 days with support. In this way, while pharmaceutical companies increase their productivity, patients will be able to obtain the drugs produced in a shorter time.
• Effective incentives for innovation will be made: The legal protection that will be provided by Intellectual Property Law to innovative drugs for a maximum of 12 years will ensure that Europe remains an important center for innovation. One of the key elements of reform, the idea of creating a single market for medicines, would be a more effective incentive for innovation that also supports the public health interest, than a single regulatory protection that would apply to all, with the current future system. The combination of existing Intellectual Property Rights and new regulatory protections will also preserve the EU's relevant competitiveness around the world. With this reform, patients will have timely and equitable access to medicines.
• Monitoring and taking measures against drug shortages: With the reform, drug shortages in countries will now be monitored by EMA with stronger coordination. In this context, it will be possible to monitor the relevant drug deficiencies in the countries regularly, to notify the deficiency in advance, and to ensure the continuity of people's access to the drugs. Again, in the same context, a list of drugs classified as critical in the EU age will be created and some measures will be taken for the supply of these special drugs.
• Environmental protection: The aim is to make medicines more environmentally sustainable. Environmental requirements are better enforced, both ensuring sustainability and limiting the potential negative effects of drugs on environmental health. For this purpose, new rules to be created within the scope of the reform will be prepared within the scope of the European Green Deal targets, taking into account the environmental effects of pharmaceutical production.

Ultimately, this reform addresses the amelioration of key challenges in accessing medicine in EU countries for years. As the drugs produced do not reach the patients fast enough, there are also inequalities between countries in terms of access to the same drug. It is seen that there are important problems in the dissemination of drugs that have not yet been used in the treatment of diseases and drugs that are used in rare diseases. One of the most important problems encountered in innovative treatments such as this is the high prices of drugs, making it very difficult for some patients and health systems to access drugs. With this reform, a single market will be created so that all patients in the EU can access safe, effective, and affordable medicines on equal terms without disruption. Thus, there will be improvements in eliminating the problems in the existing health system and it will be ensured that the EU remains the world leader in the drug development industry for investment.

Bibliography

[1] https://ec.europa.eu/commission/presscorner/detail/en/IP_23_1843

[2] https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/european-green-deal_en

[3]https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/promoting-our-european-way-life/european-health-union/reform-eu-pharmaceutical-legislation_en

[4] https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe_en

[5] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0761