A few days after the deadline set by European regulations, Italy has adapted its own anti -counterfeiting rule For drugs. The government thus prevented dozens of medicines used by many people could end up in commerce due to the failure to comply with European laws.
The decree, which has not yet been published in the Official Gazette, establishes a transition period of two years, during which pharmaceutical companies and pharmacies will have to be adapted to European standards. In the meantime i drugs With the Italian anti -counterfeiting method, which has shown that they work very well, they will be able to continue to be regularly sold.
The decree that saves dozens of drugs
The Quotidiano Sanità website has published the draft of a decree that the government should approve shortly and which implements the European law on anti -counterfeiting rules for drugs. It is still a temporary text, but it still represents an important step to prevent pharmacies from being forced, February 9thto collect dozens of drugs from the shelves.
The decree consists of two parties. The first establishes very severe penalties, between 50 thousand and 150 thousand euros, For pharmaceutical companies and pharmacies that violate the new anti -counterfeiting laws of the European Union. A change to the current Italian legislation on the matter, which was more permissive than the standards approved in the EU.
The second part instead establishes a transition period for the Italian drug industry, so that it is possible to adapt to the new European legislation. Another de facto derogation, after those of the last few years, which should open to a transition period with a slow introduction of the new labels and the new integrated chain control system. In this way, In 2027, Eight years of delay, Italy will also adapt to European legislation.
The European anti -counterfeiting rule
The question of European anti -counterfeiting legislation is ten -year. In the EU about 1% of the drugs is counterfeit, therefore the Union decided, in 2014, to establish new anti -counterfeiting standards. After the legislative process, in 2019 this initiative becomes mandatory for all states, with two exceptions. A few years earlier in fact Greece and Italy They developed their anti -counterfeiting system, which is working very well. In our country, in fact, only 0.1% of drugs are counterfeit.
The EU then gives the two six more years to adapt to the new rule, establishing the deadline on February 9, 2025. However, they arrived just over a week from the date, the Italian drug industry is still completely unprepared Until January 30, the government and the government had not leded any precise legislative change.
The new derogation therefore serves to face a question that has been postponed for a decade, for more or less valid reasons. Our country has an anti -counterfeiting system, but this is not integrated with the rest ofEurope. The changes that will be made in the coming years to drug packs and the control of their origin should also solve this problem, reporting the situation within European regulations.