A bad week for medical research in Italy – but science is fighting back!

The approval on Wednesday by the Italian 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 (and there have been far to many of these lately). While some of the provisions in Article 13 are quite innocuous, even rather pointless as 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.

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Italian scientists must continue to fight for the future of medical research!

Article 13 states (in translation from an article on the Pro-Test Italia website)

Article 13.

(Criteria for delegation to the Government for the transposition of Directive 2010/63/EU of the European Parliament and of the Council of 22
September 2010 on the protection of animals used for scientific purposes)

1. In the exercise of the delegation for the implementation of Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes, the Government is obliged to follow, in addition to the guiding principles and criteria referred to in Article 1, paragraph 1, the following guiding principles and specific criteria:

a) directing research to the use of alternative methods;

b) prohibit the use of primates, dogs, cats, and specimens of species in danger of extinction unless it is research aimed at human health or the species involved, conducted in accordance with the principles of Directive 2010/63 /EU, with the approval of the Ministry of Health, after consulting the Board of
Health;

c) consider the need to refer to other experiments an animal that has already been used in a procedure, to those in which the actual severity of the previous procedures was classified as “moderate” and the next one belongs to the same level of pain or both classified as ‘mild’ or ‘non-recovery’ within the meaning of Article 16 of Directive 2010/63/EU;

d) prohibit the experiments and procedures that do not provide anesthesia or analgesia, if they involve pain to the animal, except in the case of testing of anesthesia or analgesia;

e) to establish that the generation of strains of genetically modified animals must take into account the evaluation of the relationship between harm
and benefit, the actual need of the manipulation and the possible impact it could have on animal welfare, assessing the potential risks to human health and animal health and the environment;

f) prohibit the use of animals for experiments of war, for xenotransplantation and for research on drugs of abuse, in the areas of experimental and teaching exercises with the exception of university education in veterinary medicine and advanced training of doctors and veterinary preparations;

g) prohibiting the national territory in the breeding of dogs, cats and non-human primates used in experiments;

h) define a framework and appropriate sanctions such as to be effective, proportionate and dissuasive, even taking into account the Title IX-bis of Book II of the Penal Code;

i) develop alternative approaches which could provide the same level or a higher level of information than that obtained in procedures using animals but
which do not involve the use of animals or use fewer animals or involve less painful procedures, in limit the financial resources generated by the application referred to in subparagraph h), assessed and recognized in the financial statements;

l) to allocate an annual sum in the context of national and European funds for research aimed at the development and validation of alternative methods,
consistent with the commitments already made to the legislation in force, in regular training and refresher courses for operators of establishments approved and take all measures deemed appropriate in order to encourage research in this area with the obligation for the competent authority to communicate through the bank of national data, the transposition of the methods and substitutions.

2. 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.

3. Since the implementation of delegation of power referred to in this Article shall not derive new or increased charges for public finance.”

As a recent article on this blog explained, parts (d) (f) and (g) are a serious threat to biomedical research and the welfare of laboratory animals in Italy, though other parts – notably (b) and (e) - are so poorly defined that they may also cause problems. These are the amendments approved by the Italian Senate earlier in July and then by the Chamber of Deputies on Wednesday.

For example, the amendment dealing with xenotransplantation alone has the potential to hamper many areas of medical research – and even medical practice – as it does not define what is meant by “xenotransplantation”. 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 involves transplanting 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 .

These amendments must not be enforced, if they are they will do terrible damage to science in Italy. It’s a bad situation, and one more example of how the far too many Italian politicians are out of touch with science.

Fortunately there is some hope.

The law transposing the EU directive into Italian law was rushed through the Chamber of Deputies by the Italian government because Italy was facing large financial penalties due to being late in transposing and 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 agreed to delegate to the government  the drafting of the specific laws and regulations  implementating of the Directive. So now the ball is in the government’s court: it 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”.  Article 2 of Directive 2010/63/EU specifically bars countries from imposing additional stricter national restrictions on animal research unless they were in force before 9 November 2010, which of course means that the most worrisome amendments in Article 13 are actually in breach of Directive 2010/63/EU.

As an article posted earlier today on the Pro-Test Italia website (in Italian) points out the Italian government, and specifically health Minister Beatrice Lorenzin, has accepted the advice of the parliamentary commission and several orders-of-the-day made by deputies who do realise the importance of animal research on Wednesday that some of the amendments in article 13 are highly problematic both legally and scientifically. 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 an increasing number of Italian politicians. The mobilization of the scientific community in Italy on this issue in the past few weeks has been unprecedented, and our friends in Pro-Test Italia have played a leading role in encouraging and coordinating that response. Now is the time for the Italian scientific community – and their colleagues throughout Europe and beyond – to redouble their efforts and make sure that these amendments are consigned to the dustbin of history where they belong.

Paul Browne

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