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The EU Commission’s Failure to Update Medicine Regulations Will Have Consequences

Pernille Weiss MEP by Pernille Weiss MEP
11 May 2024
in Opinion
Pharmaceutical,Industry,Man,Worker,In,Protective,Clothing,Operating,Production,Of

Pharmaceutical industry man worker in protective clothing operating production of tablets in sterile working conditions

If the commission does not act promptly in updating its medicine regulations it could result in the loss of the European pharmaceutical industry to more innovative continents and countries.

Belgium, (Brussels Morning Newspaper) The pharmaceutical industry is essential to the European Union’s economy. Therefore, the EU Commission’s delay in updating its medicine regulations could have severe consequences for the industry’s competitiveness. With the increasing demand for medical solutions to health and disease challenges, the need for updated regulations has never been more pressing. Unfortunately, the EU Commission has repeatedly postponed the release of the updated directives and regulations, which could have a detrimental effect on the industry’s future in Europe.

Despite the urgency of the situation, the EU Commission’s initiative to update and modernize its regulatory system for medicines has now been delayed once again. Originally expected by the end of last year, the initiative was pushed back to the middle of March and then delayed even further. It is absolutely crucial that the Commission takes swift action to address the challenges facing the pharmaceutical industry in Europe and ensure its competitiveness on the global stage. The latest update is that the pharma package will land on the table of the co-legislators no later than the end of April. 

Pushing back the publication of the legislative proposal of the pharma package raises concerns about the feasibility of finalizing the legislation within the current legislative term, which ends in the second half of 2024. This delay may impact the EU’s ability to ensure timely implementation of the new medicines regulatory system, and ultimately impact patients’ access to the medicines they need.

The pharma package, which includes updated directives and regulations, is critical to the future of the European pharmaceutical industry. The updated regulations must reflect the current reality of new technologies, the rising demand for medical solutions, the threat of epidemics and pandemics, demographic changes, and the great need for research and innovation. Furthermore, the regulations should provide a level playing field for the industry, allowing it to compete effectively in the global marketplace.

The current regulatory environment in Europe is complex, which makes it difficult for the pharmaceutical industry to operate effectively. The regulations must be simplified to ensure that the industry can thrive in the new era of innovation. The EU Commission must take steps to provide a more predictable and stable environment for the pharmaceutical industry, which will encourage investment and ensure the industry’s continued growth in Europe.

The pharma package is also essential for retaining pharmaceutical investments and patents in Europe. The US is currently attracting more investment in biotech research and development than Europe. The financial access to capital is also significantly higher in the US, South Korea, China, and India than in Europe. Furthermore, the US has filed twice as many patents as Europe, with many of those patents being owned by American companies. The fact is unfortunately that in 2020, the US granted 12,000 new patents compared to only 6,000 in Europe, of which 2,600 are actually owned by American companies.

The European pharmaceutical industry is essential to the EU’s economy, and it is vital that the industry remains competitive. The EU Commission must take action to update its regulations to ensure that the industry can thrive in the new era of innovation. Failure to do so could result in the loss of the industry to other, more innovative continents and countries.

It is time for the EU Commission to act and provide a more predictable and stable regulatory environment for the pharmaceutical industry. The pharma package must be released to the political arena to ensure that the updated regulations can be debated and implemented. The industry’s future in Europe depends on it.

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