Timmermans’ ‘Better Regulation Plan’ is a step in right direction

By European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan

This week saw the unveiling of the European Commission’s ‘Better Regulation Plan’, with its aim to streamline regulation, cut red tape and help the EU to be “big on big things, small on small things”.

Acting under the brief provided by Commission President Jean-Claude Juncker – who hailed the plan as one of his key policy goals – Commissioner Frans Timmermans said he and his colleagues are “determined to change both what the Union does and how it does it” and pointed out that citizens and businesses feel that: “Brussels and its institutions don’t always deliver rules they can understand or apply.”

It would be difficult to argue with that assessment when 70% of Europeans are of the opinion that EU laws are over-complex, often unnecessary and, on occasion, downright frivolous.

Eurosceptic parties across the 28 member states have been gaining ground by lambasting the way the Union works and, of course, there’s the not-so-small matter of an upcoming in-out referendum in the UK. British Prime Minister David Cameron is set to try and negotiate changes in the EU’s system in a bid to keep his country as a member of the bloc.

Already, Timmerman’s plans have been challenged in some quarters as being merely a cover-up job for a lack of regulation citing that he has been quoted as saying: “Legislation is not the answer to every problem and there are problems that we need to tackle that we can tackle without creating new legislation.”

But he said the following during a Strasbourg press conference this week: “Better regulation is not about more or less EU rules, or undermining our high social and environmental standards, our health or our fundamental rights. Better regulation is about making sure we deliver on the ambitious policy goals we have set ourselves in the most efficient way.”

The task set for Timmermans was to identify regulations that can be dismantled, changed or streamlined but it would not be achievable without an institutional agreement with the European Parliament and the Council of Ministers – who will now consider the proposal. An agreement should be reached by the end of this year but key is reducing the incidence of member states' governments adding ‘local’ elements onto EU-formulated laws (known to Brussels insiders as ‘gold-plating’.

After wrangling over leaked earlier drafts, the final document aims to “deliver tangible and sustainable benefits for citizens, business and society as a whole”. Its introduction contains the mantra that better regulation is “essential for sustainable development” and “underpins the European social model”.

But not everyone is convinced. While businesses generally have backed the plan as a step in the right direction, some NGOs, trade unions and other groups have quickly formed a ‘Better Regulation Watchdog’ to monitor whether regulatory proposals would undermine social and environmental laws.

Timmermans clearly hgas a major challenge aead. There is no denying that the field of EU regulatory affairs is by its very nature a complex one, and plenty of interested parties will be watching developments closely.

One of these is the Brussels-based European Alliance for Personalised Medicine (EAPM), which believes that regulation is perhaps nowhere more complex than in the arena of health .

Indeed, policy- and law-making becomes extremely complicated when legislating for the exciting advances and growing expectations being brought about by personalised medicine.

Take, for example, clinical trials, in-vitro devices, national market access and data protection. The issues are labyrinthine. Yet all need to be addressed swiftly and effectively if we are to be able to give the right treatment to the right patient at the right time, while offering every European equal access to the best treatment available.

There are 28 Member States and the welfare of 500 million citizens to consider, plus so many disciplines, industries and other stakeholders involved that it is often a struggle for legislators to formulate regulations that are satisfactory for all, are up-to-date and progressive, and do the job they are supposed to do. This despite the best efforts from all involved.

Commissioner Timmermans and his boss, President Juncker, will undoubtedly be aware that much EU legislation tends to be reactive rather than proactive. There is a need to consult all stakeholders to help foresee potential problems that could occur down the line. This is clearly much better than acting in an ad-hoc manner if and when problems do occur.

Meanwhile, while member states have competence for their own health-care systems, there is undoubtedly a need for common European health legislation as much as possible. But, as Timmermans suggests, it must be the right legislation.

The Alliance sincerely hopes that, Frans Timmermans’ project will mould legislation that offers the right laws, in the right place, at the right time. In the arena of health, this will allow stakeholders to work more quickly and more effectively towards creating a healthier – and thus wealthier – European Union. We wish the commissioner well.

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