MEPs set out safer rules for innovative therapies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The European Parliament debated a draft regulation designed to foster gene therapy, somatic cell therapy and tissue engineering. The unresolved issue of "ethical amendments" poses a threat to any agreement with the Council, which, like the Commission, wants to restrict the new regulation to technical issues, leaving it to Member States to decide on any ethical conditions to be observed on their territory, under the subsidiarity principle.  

 

Commissioner Günter VERHEUGEN, Vice-President of the Commission, with responsibility for Enterprise and Industry, began by stating that "There are countless people in Europe who are ill ..[and that].. these new therapies will bring hope to many ailing people."  He clarified that he was speaking about diseases like cancer, Parkinson's disease and aids .. what he referred to as "terrible diseases".    The Commissioner went on to say that this proposal looks at easier access to treatments and makes a contribution to research standards.  The Commissioner invited MEPs, "as a matter of urgency, to expedite this procedure"  He emphasised that "it is not to be delayed further" and welcomed the fact that some of the groups had agreed on a compromise package. 

 

With regard to the question of ethical issues, the Commissioner pointed out that this law is about making sure "that the patient receives effective medicines ... it is not intending to do anything else ..[..]..  What we are doing is strictly observing the principle of subsidiarity because ethical matters are the responsibility of Member States."  The Commissioner concluded by stating that "Above all ladies and gentlemen, you would be helping to save the lives of those who are seriously ill.

 

The rappporteur Miroslav MIKOLÁŠIK (EPP-ED, SK) expressed his disapproval of the compromise arrived at, without his knowledge, by three MEPs and representatives of the Council and of the Commission.  He pointed out that these amendments did not have the support of the Committees nor of the rapporteur.  He emphasised that he was addressing the Plenary Session as the rapporteur on this issue and that "since the beginning of 2006 the EP has been working hard on this proposal ..[that].. the final report [was] adopted by a large majority." 

 

In addition, the rapporteur explained that there was one aspect of the proposal which still worried him: that the European Commission had introduced an opt-out for some Member States concerning contentious products - "In practice, this would mean that certain products would not have access to all markets."  The rapporteur went on to say that this position could not be upheld legally.

 

Giles CHICHESTER (EPP-ED, UK ), for the Committee on Industry, Research and Energy, said that he supported this proposal and hoped that it will go forward smoothly. He said: "I regularly see reports in the press of exciting new therapies and developments in this field. But usually they are in the USA and not in Europe, which is to our loss. I have to say, with respect to the rapporteur, I would like to congratulate him for his work but I have to respectfully disagree with him with regard to the two amendments from the Legal Affairs Committee which seemed to me, and to many on my committee, to be pushing in exactly the opposite, retrogressive direction of this proposal. So I join in supporting the compromise package which has been put forward, particularly by my distinguished colleague Mrs Roth-Behrendt, not least because independent observers tell me that this package is in line with the ITRE research committee's position. So naturally I support it. "

 

Hiltrud BREYER (Greens/EFA, DE). on the other hand for the Legal Affairs Committee. said that the committee had a right to present amendments on ethical issues. Amendment 17 as proposed by the Legal Affairs Committee and which is not part of the proposed compromise reads "This Regulation shall not apply to advanced therapy medicinal products that contain or are derived from human embryonic or foetal cells, primordial germ cells or cells derived from those cells."

 

 

John BOWIS (EPP-ED, UK) said: "It is, as the Commissioner has said, an exciting time in medical research. We are on the verge of a new breakthrough and the root for this is the development of advanced therapies, using gene and cell therapies and tissue engineering. Gene therapy and somatic cell therapy products are already being clinically tested - some of the tissue engineering products are already with us and so this proposal is there to ensure that we deal with a complex issue in a sensible and universal way, through central authorisation so that we can pool scarce expertise at Community level, ensure the highest standards of patient safety across the EU and enable access to the European market and thus to all patients.

 

That is what it is all about and on the basis of that I do welcome my honourable friend's report and congratulated him on the work that he did, not only in bringing the reports through  out Environmental Committee but in the subsequent work he has done negotiating with the Presidency, in the trialogue, and we have needed to look at various issues, the hospital issue, the small, medium enterprise issue, the medical devices issue. And of course with this comes a number of ethical issues and those are important but my belief certainly is that the EU's job is to guarantee safety and efficiency and Member States should take the ethical decisions. That is where I believe we will conclude on this important measure and we now have to look very carefully at the options before us in the votes on Wednesday to make sure that we take something through which has the whole hearted support of this House."

 

Dagmar ROTH-BEHRENDT (PES, DE) focussed her comments on the procedure, stating that thousands of patients were waiting for treatment based on advanced therapies. Ms Roth-Behrendt said: "We tabled a package of 75 amendments. 32 are exactly identical to the amendments from the committee; 18 amendments are slight linguistic changes; 10 amendments are working on a compromise which you and I agreed on already before you stopped cooperating and 15 amendments are linguistic or legal concerns. That is the situation where we are at the moment.

 

Then I have to say something on the so-called 'ethical' amendments. Yes, Member States who want to ban the use of foetal stem cells should be allowed to do that and everybody who says that the Court of Justice would deny that and would put it under Article 95 is either not knowledgeable, and then giving the wrong impression I am afraid. If you read Article 30 of the Treaty, you are exactly sure that Article 30 says public morality is always a reason to make sure that a Member State can ban that. And that is what happened in the past. That is what happens at the moment in the European Union and those Member States who allow research on that (we always said they could continue) but the patients there also deserve the right to have the safest, best products available, and that is why I tabled an amendment on subsidiarity making it sure again (and that amendment is in the package). That amendment says that every Member State which thinks a product should not even be produced there, nor marketed, should be allowed to ban it. For other Member States, the patients should have the freedom to get that. That is what we are here for."

 

Frédérique RIES (ALDE, BE) said that the regulation offered a practical solution to thousands of patients who are awaiting progress on cures for a range of diseases including Parkinson and Alzheimer's.  In the medium, she said, this could also offer a solution to the problem of the lack of organs.  Mrs Ries stressed that the compromise put forward by the main political groups would allow the Member States to decide on ethical issues according to their respective national laws. "The EU had no power or right to legislate on ethical matters". Mrs Ries also pointed out that the Commission supported this position.  Finally, Mrs Ries stated that the European Parliament had supported EU funding on stem cell research as long as it respected national rules. 

 

Konrad SZYMAŃSKI, (PL) speaking for the UEN group, warned that "despite great efforts made by the rapporteur", the proposal on advanced therapies "may have serious shortcomings", for if the package of amendments is not supported there is the danger that "there may not be enough guarantees for human dignities." If Europe rightly wants to set human rights standards in the world, Mr Szymański continued, it could not afford to adopt a "passive position", when it comes to advanced therapies.

 

Hiltrud BREYER (Greens/EFA, DE), hoped that the vote on this proposal "will prove to be a touchstone" in that in might constitute the "incorporation of European values in legislation."  Ensuring the "non-commercial of the human body" is essential, and it is also important to "avoid genetic interventions" and recognise the need for "clear bans" on the issue. A "disastrous signal" will be sent out, Mrs Breyer added, tantamount to a "breaking down of the ethical dam", if the EP were to abandon its opposition on these ethical principles, for "we have to speak out clearly in favour of European values."

 

The purpose of this proposal, Adamos ADAMOU (GUE/NGL, CY) said, is to "allow Member States to decide themselves whether or not they can use these ethically sensitive products." There is, he added, "no room in the text for personal ethical views." Furthermore, if a compromise can be reached on the first reading, it will mean that, in the near future, "These new technologies can allow [patients] to have more effective treatment."

 

There are very serious doubts, said Johannes BLOKLAND (IND/DEM, NL) about "the technical possibilities of therapy based on germ-line modifying therapy and human hybrids." It is, he continued, "my serious hope that such products can be kept outside the scope of this regulation", so as to "enable us to maintain the dignity of the human body." The proposal in its current form, Mr Blokland added, might mean that "a national ban on any European-authorised products could potentially be attacked in court."

 

 

Proinsias DE ROSSA (PES, IE) thanked those Members who participated in the detailed processing of this regulation. It is extremely important, he said that issues as sensitive and complex as this are dealt with under the codecision procedure. It reassures our citizens whose national parliaments cannot vary a regulation to see their MEPs engaged in preparing balanced and effective legislation which seeks to enhance their lives.

 

Continuing, Mr De Rossa stated that the therapies which this regulation seeks to deal with have great potential for treating cancer, Alzheimer's and Parkinson's disease. Regrettably, and not unexpectedly, some reactionary elements are falsely claiming that this proposal overrides Member States' rights on ethical issues. They want to exclude products derived from embryonic stem cells from the remit of this regulation. The effect of doing so would be to leave such products unregulated in many parts of Europe as regards their safety, quality and efficacy.

 

Contrary to these wild claims, the regulation, he said, does not circumscribe a Member State's right to refuse to countenance embryo- or stem-cell-based therapies. Indeed he stated that he would deplore such a ban by any Member State. This regulation is about saving life and about enhancing the quality of life, not its destruction – as is being claimed by some in this House tonight, he said. "We owe it to tens of thousands of patients and their families to do everything we can to encourage and make available the most advanced treatments for some of the most intractable illnesses facing our societies today. We also need to guarantee insofar as we can that they are safe and of the highest quality and that they actually work. This is what this regulation seeks to do. I fully support the Socialist Group position and call on all Members – and indeed I would particularly call on all my Irish colleagues – to support this regulation."

 

Kathy SINNOTT (IND/DEM, IE) referred to the visit of the Ukrainian Prime Minister to the European Parliament last month. In a discussion in committee, Mrs Sinnott stated that she had asked him about the trade in human body parts, especially of infants before and after birth. The Prime Minister acknowledged this gruesome trade and called it painful. He reminded her that it also included embryos. He said the problem was not only Ukrainian sellers but also the wealthy international buyers

 

Continuing Mrs Sinnot stated "He asked for our help to end this form of human trafficking. Our help. Tomorrow's vote will determine whether we have any help to give. If we uphold the ban on commercialisation and if we exclude human embryos from the scope of this directive, then we will be able to do something about the wealthy buyers within the EU. If, however, we give the green light to commercialisation and destruction of embryos, not only will we be unable to help Ukraine with the buyers who keep the trade alive, but we will also cause the same painful situation in the EU, whereby those who are desperate for money are exploited for their body parts to benefit those who are rich enough to pay for them."

 

John PURVIS (PPE-DE, UK). stated that there are many European families with members suffering from serious diseases. There are also many medical researchers and therapists with the means to help those patients, and they are all waiting for this important piece of legislation. It will provide the common legislative framework which will make these innovative therapies more readily, more widely and more safely available. It is urgently required, it will be of great benefit and there is no reason for delaying its implementation by loading it with unnecessary ethical provisos and carve-outs that are impossible to agree with the Council.

 

"It has been firmly established that ethical restrictions are properly within the power of individual Member States if they wish to limit or forbid. Subsidiarity is the essential rule. But there is every reason to have a European standard for regulating the safe use of such therapies where they are used. So I ask my colleagues, and particularly my good friend the rapporteur, to let this vitally important piece of legislation proceed this week, so that agreement with the Council can be reached.

 

Many of our less fortunate fellow Europeans will thank us when this legislation comes into effect, but they will have great difficulty understanding if it is further delayed, emasculated or stopped altogether by this Parliament. This is one of those occasions when it is really important for us to exercise our powers carefully and responsibly and let this matter be finalised."