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News from Mitocon: Italy leads the way in the European Union with a secondary legislation for testing mitochondrial DNA replacement techniques

27 February 2024

(For the press release in original Italian, see here)

The first law regulating the testing of mitochondrial replacement techniques within medically assisted procreation is finally a reality in Italy. 

It was presented on 27th February 2024 at the Luigi Sturzo Institute at the start of an important regulatory path promoted by Mitocon, the reference organization in Italy for people with mitochondrial diseases, and founding member of IMP with Sen. Ignazio Zullo as its first signatory.

Italy is thus a candidate to be the first country in the European Union and the third in the world to adopt a measure dedicated to the prevention of mitochondrial diseases, rare and serious diseases that affect one in 4,300 people worldwide, causing major disabilities in both adults and children, so much so that their life expectancy is reduced.

Significantly reducing the risk of a child inheriting the disease from its mother is the most important purpose of these IVF techniques, in which 'defective' maternal mitochondria are replaced with healthy mitochondria from an anonymous donor. The Secondary Legislation  intends to focus on the process of mtDNA replacement, which does not affect the physical or intellectual characteristics of the future child but solves a health problem.

These techniques have already been used in England for nearly a decade. In Australia in 2022 a law was finally passed allowing their use within a 10-year clinical trial.

The Bill consists of six Articles : Article 1 provides a delegation of authority to the Government to define the techniques of medically assisted procreation through the testing of Mitochondrial replacement for female carriers of Mitochondrial DNA mutations.  Article 2 identifies the principles and directive criteria to be followed for the adoption of the legislative decrees specified in Article 1.  Article 3 gives the Minister of Health the task of identifying the Centre for experimentation on medically assisted procreation from among those included in the National Register of Facilities authorised for the application of PMA techniques.  Article 4 regulates the modalities through which informed consent is given while article 5 gives the Minister of Health the task of preparing a report on the activity carried out by the National Centre for Experimentation on PMA.Finally, Article 6 presents as its subject matter the financial provisions.

“The presentation of this Bill is the culmination of a path that Mitocon started about two years ago and that has allowed to reflect on the necessity of Mitochondrial replacement techniques with lots of different subjects from the world of research, of health institutions and society in general” emphasises Piero Santantonio, founder and past President of Mitocon.  

This dialogue highlighted almost unanimously both the importance of the techniques as a tool to prevent the transmission of these terrible diseases and the need for Italy, which has an important scientific tradition in this regard, to continue to invest in research, in the field of Mitochondrial diseases that are increasingly connected to other and much more widespread neurodegenerative diseases.

On behalf of Mitocon we thank all the stakeholders who have helped us explore these issues, to our patients and their families.  Now awaits the important step of conversion into law which we hope will be accomplished as soon as possible.

© 2024 Int. Mito Patients