#EAPM - 'Patchwork' rules won’t mend those genes

Let’s talk about genomics - yes, let’s - and the power that is about to be unleashed by this relatively new and fast-developing technology, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Peeking just a couple of years down the line and we see that the EU’s regulations in this arena will become more harmonized, with a deadline looming for new rules on genetic testing. In the interim, lots of work is being done to formulate guidelines that can be trusted across Member States and various sectors.

Will the UK be on board? We’ll see… But is is already embedding genetic testing into the NHS via the country’s Genomic Medicine Service. Denmark is making serious moves, too, as is France. The future’s bright, the future’s genetic.

It may not be so far, far away that each embryo has its DNA sequenced, letting parents know about risks for their kids, while the parents themselves - and everyone else -  will be aware of any genetic mutations they are carrying. Full-gene sequencing may even be available through EU healthcare systems.

We’re not there yet, though. If ‘Workington Man’ wants to get to know his genetic make-up better, he’ll currently have to do it via direct-to-consumer (DTC) genetic testing - an industry that’s raking in the millions and millions of euro, dollars and pounds.

But there are issues regulating this industry - and a lot of governments are scratching their heads. In France, the whole kit-and-caboodle is banned. In the UK, where it’s legal, an inquiry was due to be held, but wasn’t in the end, due to parliament closing for the election. 

Pascal Borry, who is professor of bioethics at the University of Leuven’s Centre for Biomedical Ethics and Law, has described current regulation as a ‘patchwork’, leaning on consumer protection laws, as well as some of those regulating in vitro diagnostic medical devices.

But work is ongoing, as mentioned, to bring some harmony to the current cacophony at international, EU and Member State levels, with the EU-funded SIENNA project set to finish work on genetics and genomics.

SIENNA aims to develop tools such as ethical frameworks and codes of conduct, while looking closely at the advertising of DTC tests.

The project has researchers in the Netherlands, Sweden, Poland, Germany, Spain, Greece, France and the UK, and officially comes to an end in March next year - although guidelines may well be issued sooner.

Meanwhile, there is another set of rules (albeit voluntary) which have seen the Czech Republic, Norway, Portugal and Slovenia climb onboard. This is the Council of Europe’s protocol and, in 2022, member states will have no choice but to join.

The implications of all the above will be up for discussion at EAPM’s presidency conference coming up on in Brussels from 24-25 March.

2020 up-and-running

The Croatian EU Council Presidency started the year by presenting its programme until the end of June, which includes organ donation and an ageing society). meanwhile, Ursula von der Leyen’s European Commission is addressing blood, tissue and cells legislation.

Meanwhile, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have co-written a paper highlighting how difficult it is for regulators to evaluate the quality of big data.

As they write: “Not all datasets are the same.” 

Different groups are generating data under “different scenarios and for different purposes and ownership resides with multiple stakeholders, many of whom have no obligation to engage with regulatory systems”, the paper reads.

Speaking of the von der Leyen Commission, it has been asked by Belgian MEP Cindy Franssen whether pharmaceutical companies pulling medicines out of some member states for commercial reasons and causing shortages should be held accountable for violating an EU 2001 directive.

The directive in question requires them to make medicine available. 

The Belgian deputy also wants to know how the Commission plans “to tackle the growing shortages and improve coordination between member states”, as well as how it intends to propose to increase production of medicines in the EU.

Over in Malta, EAPM supporter and Health Minister Chris Fearne didn’t quite make it in his bid to become the country’s next Prime Minister, after a vote in a Labour leadership contest held recently. 

And there could be a change at the top in Ireland, with the EU member state set to hold an election on 8 February. Current Prime Minister Leo Varadkar leads a minority government which is currently backed by the main opposition party.

Varadkar has said that the election should happen at the best time for the country, and “now is that time” as he looks over a landscape that features a Brexit deal, restored power sharing in Northern Ireland, and a long demonstration of solidarity with Ireland by the rest of the EU during the aforementioned Brexit wrangles.

And there could be more of those to come, as the EU’s chief Brexit negotiator Michel Barnier has said that goods entering Northern Ireland from Great Britain post-Brexit will be subject to checks and controls. This directly contradicts statements made by Westminster.

Up in Bonny Scotland things are not-too-bonny for Scottish First Minister Nicola Sturgeon and other supporters of independence, as UK Prime Minister Boris Johnson has rejected Sturgeon’s demand for a second independence referendum.

“The Scottish people voted decisively to keep our United Kingdom together, a result which both the Scottish and UK governments committed to respect,” tweeted the premier.

More on Brexit

Commission chief von der Leyen has revealed that in the region of 2.5 million Europeans have applied for residence status in the UK, and urged Britain.to create an independent watchdog to deal with any EU citizens’ complaints against Boris Johnson’s government down the line.

Of course, the European Parliament’s Brexit Coordinator Guy Verhofstadt is on record as demanding that EU citizens’ rights are a priority in upcoming negotiations on the future relationship.

The Belgian former prime minister took to Twitter to say: “I cannot imagine the EU will agree to any free-trade deal if there are outstanding concerns about the treatment of EU citizens in the UK.” 

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