Advanced Therapies Regulation: important vote at European Parliament this week


ADVANCED THERAPIES REGULATION 


Members of the European Parliament to vote on Advanced Therapies this week


The European Parliament will this week vote on new legislation on Advanced Therapies which involves creating an EU-wide body to authorise gene, cell- and tissue- based medicinal products. During a recent vote in the European Parliament’s Environment committee, important ‘ethical amendments’ to the Report were rejected by MEPs. Some MEPs have voiced strong opposition to any ethical questions being included in the Report. Patient groups expect that the Regulation will ease access to advanced medical treatments. However, WYA believes that the right safeguards need to be put in place to ensure these treatments are produced and used in a safe and ethical way, which does not undermine the dignity of the person now or in the future.


WYA urges Members and citizens to contact their Members of the European Parliament, asking them to reflect on crucial issues affected by proposed Regulation on Advanced Therapies which will be voted on in Strasbourg this Wednesday.


There are four main issues:

-The principle of subsidiary: Respect for national rules restricting the use of any specific type of human cells, for example the use of human embryonic stem cells
-The principle of non-commercialisation of the human body
-The prohibition of the germ line intervention
-The prohibition of the production of Hybrids and Chimeras


Amendments reflecting WYA’s concerns have been tabled by the Legal Affairs committee – JURI Amendments 17 & 3 – and by the Members of the European Parliament, from diverse Political groups:  Amendments 71 – 81 were tabled by Giuseppe Gargani, Margrete Auken, Philippe Morillon, Kathy Sinnott, Sylvia-Yvonne Kaufmann and Brian Crowley.  They were co-signed by at least 68 MEPs before last week’s tabling deadline. An important new amendment has also been proposed by Miroslav Mikolasik, on behalf of the EPP-ED group – Amendment 157.


The amendments proposed by the above mentioned MEPs need support before the vote in Plenary which is expected this Wednesday. Please contact MEPs from your country to urge them to support the position of the Legal Affairs committee and the ethical amendments which have been put forward. It is important to maintain the bans on germ-line intervention, the creation of hybrids and chimeras and the commercialisation of the human body, and to ensure that EU countries retain the right to ban products which are ethically contentious. The European Medicines Agency should be obliged to scrutinize whether the principle of non-commercialisation of the human body is respected. Furthermore there should be no European Authorisation for products altering the genetic identity of the human germ line as well as for products having been procured from Hybrids and Chimeras or rather containing tissues and cells which have been procured from them.

We thank you for your attention to these important issues. 

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Summary of Concerns


We invite all Members of the European Parliament to reflect on the proposed Regulation on Advanced Therapies which will be voted at the plenary session of the European Parliament this Wednesday. The Regulation will ensure that Advanced Therapy medicinal products, products based on genes, cells and tissue, will be subject to a European authorisation. National authorization standards will become unnecessary and unworkable, so the proposed Regulation must clarify which standards have to be met in order for a product to qualify for European authorisation. In the interests of safety and legal certainty, the proposed Regulation should be compatible with the standards, which have already been established, in European legislation such as the Patents Directive, Human Tissues and Cells Directive and Clinical Trials Directive. It is imperative that the following ethical principles and standards should be observed:








The principle of subsidiary


The subsidiarity principle requires that member states keep the competence to legislate on the most fundamental and controversial ethical issues. The EU should respect divergent national rules restricting the use of any specific type of human cells, for example the use of human embryonic stem cells. Whilst the European Commission emphasises that the use or the prohibition of such cells must be decided on national level[1] , the Legal Service of the European Parliament concluded that the solution proposed by the European Commission in Article 28 (2)[2] is not compatible with the legal base Article 95 EC-Treaty. The protection of the principle of subsidiarity must not be left conditional on future judgments of the European Court of Justice which may challenge the interpretation of the proposed wording on subsidiarity Art 28(2), as incompatible with the legal base. Only the solution proposed in Amendments 17 and 3 (JURI Amendments) would guarantee a certain degree of safety for Member States by excluding certain controversial products and cells from the scope of the Regulation without reducing the beneficial effects of this Regulation for patients. Amendment 157 builds upon a proposal of the European Parliament Legal Service to amend the Commission’s wording for Art 28 (2) and is therefore a necessary fall-back position which should also be supported.

Please support Amendments 17, 3 and 157



[1] “The proposed Regulation does not interfere with national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products based on such cells. Explicit provisions have been introduced in the proposal to clarify this point ” (Commission proposal, Explanatory Memorandum point 3.5).



[2] The European Commission proposed that Article 28 II of the proposed regulation would amend Directive 2001/83/EC in the following way: ” This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells. The Member States shall communicate the national legislation concerned to the Commission “.






The principle of non-commercialisation of the human body

The Regulation should oblige Member State to ensure that the donation of human cells and tissues is voluntary and unpaid, the procurement of tissues and cells is carried out on a non-profit basis and the donation, procurement and testing of human tissues and cells should comply with high standards of quality and safety. Member State representatives should vote to ensure that the principle of non-commercialisation of the human body is respected, particularly given the recent concerns over egg-cell trade and trade in human tissue and organs.


Please support Amendments 72, 78, 81







The prohibition of germ line intervention


Human dignity is compromised when inheritance of human genetic identity is altered. The Legal Affairs Committee and the Committee for Industry, Research and Energy both adopted amendments for the proposed Regulation to ban germ line interventions. Members of the European Parliament and EU Council of Ministers should ensure that there will be no EU authorisation for products which alter the germ line genetic heritage of human beings and future generations.


Please support Amendments 73, 79




The prohibition of the production of Hybrids and Chimeras

The creation of hybrids and chimeras with mixed animal-human DNA raises severe safety issues and involves an unacceptable affront to human dignity. The Oviedo Convention specifically forbids the creation of human embryos expressly for the purpose of research experiments. This prohibition should also apply to any mixed animal-human embryos. The European Parliament and EU Council of Ministers should ensure that there will be no EU authorisation of products derived from human animal hybrids.


Please support Amendments 74, 76, 77, 80


For further enquires e-mail europe@wya.net