Legal memo requested by MEPs shows that regulations violate directive that requires EU approval –
LONDON – The so-called “three-parent embryo” legislation that the United Kingdom’s House of Commons passed Feb. 3 likely breaches a European Union directive to which the UK is obligated. That’s the conclusion of a legal memo Alliance Defending Freedom provided Thursday to the European Parliament at the request of several MEPs.
“Politicians should not be allowed to skirt the law just because they want to push through legislation that might otherwise receive appropriate scrutiny,” said ADF Legal Counsel Robert Clarke, who is also a barrister admitted to the Bar of England and Wales. “It’s quite clear that the UK cannot simply bypass its obligations under Article 9 of the European Union’s Clinical Trials Directive, which prohibits the government from legislating anything that alters the human germ line.”
British MPs in the House of Commons voted to pass the Human Fertilisation and Embryology (Mitochondrial Donation) Regulations of 2015 with 382 votes for and 128 against. The legislation next goes to the House of Lords for a vote and could come into force as early as October 2015 if passed there.
The UK regulations permit a certain type of DNA transfer to take place in the creation of human embryos so that the embryo will contain DNA from three parents. The stated goal is to enable women with mitochondrial problems to have genetically related children without the risk of passing on a mitochondrial disease, but many fear the germ-line-altering procedure is unethical, could be abused, or needs additional research. The new regulations would empower a UK government agency to grant licenses to allow mitochondrial donation.
“If enacted, this legislation is clearly open to legal action at the Court of Justice of the European Union,” said ADF Senior Counsel Roger Kiska. “The House of Commons could avoid this by dropping the legislation before it reaches the House of Lords in light of the Clinical Trials Directive.”
Couples can be helped without tampering with the building blocks of humanity.
“The UK’s proposals violate fundamental standards of human dignity and integrity of the person,” said MEP Dr. Miroslav Mikolášik. “They are out of line with the rest of the European Union and civilized world. Couples can be helped without tampering with the building blocks of humanity. The issue comes down to fundamental human rights and the constitutional traditions of the member states of the Union. That is the focus of the Charter of Fundamental Rights, which is now enshrined in the Treaties and binding on the UK when acting within the scope of Union law.”
Article 9(6) of the EU’s Clinical Trials Directive, to which the UK is bound, states, “Written authorisation shall be required before commencing clinical trials involving medicinal products for gene therapy, somatic cell therapy including xenogenic cell therapy, and all medicinal products containing genetically modified organisms. No gene therapy trials may be carried out which result in modifications to the subject’s germ line genetic identity.”
“It is not open to the UK to bypass the clear terms of that legislation with a side step…,” the ADF memo explains. “Despite the UK government’s assertion to the contrary, it seems relatively clear that the regulations would be captured by the EU clinical trials directive. If they are so captured…, Article 9 is unequivocal in its prohibition on gene therapy which modifies the germ line – something which the government accepts is the result of these techniques.”
Pronunciation guide: Kiska (KISH’-kuh), Mikolášik (Mih-KOH’-lah-shick)
ADF International is an alliance-building, non-profit legal organization that advocates for the right of people to freely live out their faith