2023-11-06 21:13:16
He change of legislation pharmaceutical europea alarm to the sector. The dire forecasts seem to be confirmed in analyst studies. The last one, of the consulting firm Dolon and disclosed by the Spanish employers Farmindustriapoints out that the pharmaceutical legislation being carried out by the European Commission “will have very negative impacts on Investigation and development of new medicines on the continent.” As a consequence, Europe’s weight in research and development (I+D) sector will fall 35%. Farmaindustria highlights that the European change will “seriously damage” European competitiveness, making it difficult for Europe to attract investments, launch new treatments for patients and keep pace with other more ambitious regions in this field, such as the US, China and Japan.
Specifically, the report indicates that the review in the current terms will make Europe’s weight in the R&D of medicines be reduced by up to a third, going from representing 32% today to only 22% in 2040, which represents a reduction of 35%. This drop is equivalent to 2 billion euros in lost R&D investments each year in Europe.
The study analyzes in detail the impact that one of the measures contemplated in the project will have, that of the reduction of registration data protection. The current project proposes lowering the basic period of the regulatory data protection (PDR), a vital component of intellectual property, especially important for advanced and complex therapies.
The report indicates that this measure would reduce the incentive for companies to invest in these drugs by up to 55% over the next 15 years, which would cause one in five drug research and development projects that depend on RDTs to no longer be economically viable in Europe.
As a consequence, the report highlights, Europe would lose research and development of around 50 of the 225 new treatments planned for the next 15 years, leaving many patients without a possible treatment. This figure represents an 8% drop in total pharmaceutical innovation in Europe. The study estimates that the loss of this amount of innovation would translate into 16 million years of life lost (YLL) due to increased mortality and premature death across the EU.
Research feasibility
According to the study, the European biotechnology sector (made up mostly of small and medium-sized companies) would be the most affected by the proposals, worsening a situation in which the European biotechnology base is already shifting towards the more predictable financial ecosystems of the United States and China. Research shows that nine out of ten biotechnology research projects for medicines that rely on RDTs would be at risk because they would no longer be economically viable.
The European pharmaceutical sector is torn between defending its interests and the bad image that in some areas is attributed to the sector, greatly strengthened after the pandemic. One of the big problems of the sector in Europe is the great dependence on the production of basic active ingredients, which are mainly produced in India and China. There is also fear that parallel trade in medicines and shortages will increasingly grow. Along these lines, the European Commission has sent a formal request this Monday to Aliexpress to report on the measures put in place to comply with its obligations to protect consumers from the sale of fake drugs.
Aliexpress Surveillance
Within the framework of the Digital Services legislation, Brussels asks the Chinese online sales platform to provide more information on the measures it has adopted to comply with obligations related to risk assessments and measures to protect consumers. The European Executive has its eyes set on the spread of illegal products such as fake medicines, as reported in a statement.
Aliexpress has until November 27 to respond to questions from the European Executive which, once it evaluates the situation, can take steps and open a formal process with which it can impose fines for incorrect, incomplete or misleading information in response to a request of information. If the platform does not respond, Brussels may decide to request the information by decision. In this case, failure to respond within the established period could give rise to periodic penalty payments.
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