HE legislative change pharmaceutical European An alarm was given to the sector. The dire predictions appear to be confirmed in analyst studies. last one, Dolon consultancy and announced by Spanish employers farmindustriaHe points out that drug legislation carried out by the European Commission “will have very negative effects” Research & Development number of new medicines on the continent.” As a result, Europe’s dominance in research and development (R&D) the sector will fall by 35%. Farmaindustria underlines that the change in Europe will “seriously harm” Europe’s competitiveness, making it difficult for Europe to attract investment, launch new treatments for patients and keep pace with other more assertive regions in this field, such as the USA, China and Japan.
The report states that the investigation, especially under current conditions, will increase the weight of Europe. pharmaceutical R&D will be reduced by a third, from 32% today to just 22% in 2040, representing a 35% reduction. This decline means a loss of 2 billion euros in R&D investments in Europe every year.
The study analyzes in detail the impact of one of the measures envisaged in the project, namely reducing the protection of registration data. In the current project, it is proposed to reduce the base period. regulatory data protection (PDR) is a vital component of intellectual property and is particularly important for advanced and complex treatments.
The report states that this measure will reduce the incentive for companies to invest in these drugs by up to 55% over the next 15 years, resulting in one in five drug research and development projects based on RDTs no longer being economically viable. Europe.
As a result, the report highlights that Europe will lose research and development to around 50 of the 225 new treatments planned for the next 15 years, leaving many patients without a possible cure. This figure represents an 8% decline in total pharmaceutical innovation in Europe. The study estimates that this amount of innovation loss would translate into 16 million years of life lost (YLL) due to rising mortality rates and premature deaths across the EU.
Research feasibility
According to the research, European biotechnology sector Companies (consisting mostly of small and medium-sized companies) will be most affected by the proposals, further exacerbating the situation where the European biotech base is already shifting towards the more predictable financial ecosystems of the US and China. Studies show that nine out of ten biotechnology research projects for drugs based on RDTs will be at risk because they will no longer be economically viable.
The European pharmaceutical industry is torn between defending its own interests and the bad image attributed to the sector in some areas, which has been greatly strengthened in the wake of the pandemic. One of the biggest problems of the sector in Europe is the huge dependence on the production of key active ingredients, which are mostly produced in India and China. It is also feared that parallel trade and shortages in medicines will gradually increase. In this regard, the European Commission this Monday sent a formal request to Aliexpress to report on the measures put in place to comply with its obligations to protect consumers from the sale of counterfeit medicines.
Aliexpress Surveillance
In the framework Digital Services legislationBrussels has asked the Chinese online sales platform to provide more information about the measures it has adopted to comply with obligations regarding risk assessments and measures to protect consumers. As reported in a statement, the European Administration has its eyes on the spread of illegal products such as counterfeit medicines.
AliExpress The European Administration, which has to answer the European Administration’s questions by 27 November, may take the necessary steps after assessing the situation and open a formal process in which it can impose fines for false, incomplete or misleading information in response to the request for information. If the platform does not respond, Brussels may decide to request information. In this case, failure to respond within the specified period may result in periodic penalty payments.