Farmindustria concerns about implementing decrees delay

The implementing decrees delay postpones the fully application of the new clinical research Regulation, by putting our country in a risky situation under many aspects: the Farmindustria press release

23/03/2022

Regulatory

Farmindustria February 21st press release expresses the concerns about the fate of the Italian clinical research sector.

The missed realization of the implementing decrees about new medicines development postpones the fully application of the European Clinical Experimentation Regulation in our country, which became operational last January 31st.

The delay brought several negative consequences and it is opposed to the growth and development hope, expressed by the President of the Council.

Besides, it limits the access to care (especially those innovative) to patients, and it negatively affects on other aspects, such as the chance to attract investments and the professional growth of all the specialists involved in the clinical research.

Risks with no implementing decrees

In the press release, the data of a Farmindustria survey have been published. They were about a representative sample composed of 34 companies, involved in clinical research.

86/369 clinical studies to start will follow the new community legislation. This is why they risk being carried out on a different country, if no implementing decrees will be adopted.

According to the estimates made by the Altems (Hight Institute of Economics and Health Systems Management – Cattolica University of Roma) Clinical Experiments Management Laboratory, whether these 86 studies will not start, 75.5-93.6 million Euros of investments will go wasted. Such amount of money is equal to the overall contribute that companies destine to clinical centers, by means of free medicines supply to patients involved, and the trials costs coverage.

Competitiveness loss

Today, Italy occupies a central position in the R&S clinic, thanks to institutions synergy and collaborative network, without which universities and research centers risk to remain further back than their international competitors.

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