The approval by the Chamber of Deputies of the amendments to directive 2010/63/EU – referred to as Article 13 – was a very sad day for science in Italy (there have been far to many of these lately). While some of the provisions in Article 13 are quite innocuous, even rather pointless are they just restate what the directive already says in a slightly different form of words , several of the amendments have the potential to do enormous and lasting damage to biomedical research in Italy.

A recent article on the Speaking of research website http://speakingofresearch.com/2013/07/03/senators-welcome-pro-test-italia/ highlights some of the problematic amendments in article 13, which were approved by the Italian Senate earlier in July and then by the Chamber of Deputies on Wednesday.

The amendment dealing with xenotransplantation alone has the potential affect many areas of medical research – and even medical practice – as it does not define what is meant by “xenotransplantation”. Thus it may block vital cancer research that involves xenografts or tumorgrafts, the use of porcine heart valves in cardiac surgery (a common procedure that has saved many thousands of lives) as well as research to improve those valves, block bioengineering/tissue engineering research which uses any tissues from one species in another, and even stop significant numbers of stem cell research projects where stem cells from one species are transplanted into another (e.g. human cells in mice).

These amendments must not be enforced, if they are they will do terrible damage to science in Italy.

Fortunately there is hope!

The law transposing the EU directive into Italian law was rushed through the Chamber of Deputies by the Italian government because it was facing large financial penalties due to the delay in implementing the Directive, so the government did a deal with the Deputies so that the text approved earlier by the Senate was approved without further amendment (any amendments would have been sent back to the Senate for approval again causing more delays). In doing this the Parliament approved the delegation to the government for the implementation of the Directive. So now the ball is in the government, which will have to write the legislative decrees, and the Government will have to do so in a manner consistent with the provisions of paragraph 2 of Article 13, which states that “In the application of the principles and criteria referred to in paragraph 1, the Government is obliged to respect the obligations arising from legislation or national pharmacopoeias, European or international”. As the article above mentions Directive 2010/63/EU specifically bars countries from imposing additional restrictions on animal research unless they were in force before 9 November 2010, which meant that the most worrisome amendments in Article 13 are actually in breech of Directive 2010/63/EU.

As an article on the Pro-Test Italia website http://protestitalia.wordpress.com/2013/08/02/recepimento-direttiva-sulla-protezione-degli-animali-da-esperimento-facciamo-il-punto/ earlier today points out the Italian government, and specifically health Minister Beatrice Lorenzin, has accepted the advice or the parliamentary commission and several orders-of-the-day by deputies that the amendments in article 13 are highly problematic. The Government now has the opportunity to introduce safeguards that ensure that these amendments do not harm Italian science (and lead to the EU starting infringement procedures against Italy), and to prepare new amendments to correct the problems at the next reading in the Italian parliament.

In short there is still everything to play for, and it has become apparent that the voices of science are beginning to be heard by Italian politicians. Now is the time for the Italian scientific community – and their colleagues hroughout Europe and beyond – to redouble their efforts and make sure that these amendments which threaten science in Italy are consigned to the dustbin of history where they belong!