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European brief - April 2017

Read our monthly European brief to get an overview of the key EU legislative and policy developments which impact the medical profession, as well as the work being carried out by the BMA to ensure that those developments align with our members' interests.

Read the April 2017 European brief

  • Brexit Update
  • MEPs Back Stricter Rules for Medical Devices
  • Policy Options to Tackle Trans Fats
  • European Commission Clarifies Application of Working Time Directive Rules
  • European Doctors Call for the Mandatory Labelling of Alcoholic Drinks
  • Protecting Minors from the Marketing of Alcohol and Unhealthy Food & Drinks



Brexit update

With Article 50 now invoked and confirming the UK’s departure from the EU, the BMA continues to work to secure an outcome which threatens neither the medical profession nor the patients it serves.

To this end, BMA lobbying of the EU has resulted in the EP (European Parliament) adopting - 516 votes in favour, 133 against, with 50 abstentions - a resolution setting out its key principles and condition, and which reflects key BMA priorities:

  • Recognises that the unique position of and the special circumstances confronting the island of Ireland must be addressed in the withdrawal agreement.
  • Requires the fair treatment of EU-27 citizens living or having lived in the United Kingdom and of United
  • Kingdom citizens living or having lived in the EU-27 and is of the opinion that their respective rights and interests must be given full priority in the negotiations.

Comparable positions were also set out in the European Council’s guidelines for Brexit negotiations with recognition that:

  • Agreeing reciprocal guarantees to safeguard the status and rights derived from EU law at the date of withdrawal of EU and UK citizens, and their families, affected by the United Kingdom's withdrawal from the Union will be the first priority for the negotiations.
  • In view of the unique circumstances on the island of Ireland, flexible and imaginative solutions will be required, including with the aim of avoiding a hard border, while respecting the integrity of the Union legal order. In this context, the Union should also recognise existing bilateral agreements and arrangements between the United Kingdom and Ireland which are compatible with EU law.

Recognising the necessity for key actors on both sides of the negotiating table to be aware of our concerns; chief officers, elected members and staff continue to meet with MPs, UK government officials, MEPs, EU officials and stakeholders from across Europe. For example, Dr Mark Porter, BMA council chair, met with the Chief of Staff to Guy Verhofstadt, MEP and the EP’s Brexit lead, to outline the impact that Brexit will have on the European medical profession.

Read more about our work on Brexit

Read the European Parliament's resolution

Read the European Council's guidelines

MEPs back stricter rules for medical devices

Following informal agreement of the proposals by the Council, the EP’s Plenary (full session) has approved stricter legislative proposals for medical, including in-vitro diagnostic, devices.

The rules provide for:

  • Random inspections of producers’ facilities after devices have been placed on the market
  • Stricter controls on notified bodies, which will have to employ medically skilled people
  • An additional safety checking procedure for high risk devices, such as implants or HIV tests
  • Not only a notified body, but also a special committee of experts, will check that all requirements are met,
  • An "implant card" for patients, enabling patients and doctors to track which product has been implanted
  • Clinical evidence of medical device safety to be provided by manufacturers (as for medicines), especially in the case of higher risk classes

A separate law will also ensure that the new rules also apply to in-vitro diagnostic medical devices, i.e. those that are not in direct contact with the patient, but provide health information, such as HIV, DNA or blood testing devices. With the vote coming shortly after the UK’s invocation of Article 50, Dame Glenis Willmott, Labour MEP and the EP’s rapporteur on the medical devices regulation, called on the UK government to “maintain these new laws after the UK leaves the European Union” as “it would be unacceptable if Brexit meant patients in the UK got less protection than those in the rest of the EU, or waited longer for access to new medical devices.”

Read about the regulations


Policy options to tackle trans fats

6 months after the EP’s overwhelming – 586 votes to 19, with 38 abstentions – adoption of a resolution calling on the EC (European Commission) to “propose an EU legal limit on the industrial TFA (trans fatty acids) content of all foods as soon as possible, and preferably within two years,” the EC has announced its plans.

A study, carried out by an external contractor and due to be finalised in December 2017, has been launched to assess the implications of four policy options (listed in the 2015 EC report available via the link below) on various sectors:

  1. EU introduces a mandatory TFA content declaration
  2. EU introduces a legal limit on the TFA content of food
  3. Voluntary agreements towards reducing TFA in foods and diets are made at EU level
  4. No further action towards reducing TFA in foods and diets is taken at EU level

Upon completion of this study, the EC will complete its final impact assessment before deciding on what course of action to pursue.

Whilst a public consultation is due to be launched in September 2017, its timing suggests that the views of those actors consulted in the aforementioned study by an external contractor will carry more weight. Nevertheless, the BMA will continue to work with stakeholders from across Europe to lobby for the adoption of the requisite regulation.

Read the report



European Commission clarifies application of Working Time Directive rules

Following a review process, which began in 2014 and to which the BMA contributed significantly, the EC has confirmed that it proposes to “retain the Directive un-amended while ensuring both legal clarity and its sound application.”

An Interpretative Communication to support this work has just been issued and is available via the link below.

Following the UK’s formal exit (expected to take place in 2019) from the EU, the UK government will be able to keep, amend or repeal the Working Time Regulations - the EWTD as implemented into UK law.

The BMA is satisfied with the current arrangements, as we believe it protects doctors from the dangers of overwork whilst protecting patients from overtired doctors, and would oppose any attempts to dilute this vital health and safety legislation.

Find out more


European doctors call for the mandatory labelling of alcoholic drinks

In response to the recently published report from the EC on the exemption granted to alcohol products from certain mandatory labelling requirements, a number of pan-European medical organisations - UEMO (European Union of GPs, UEMS (European Union of Medical Specialists, CPME (Standing Committee of European Doctors and EJD (European Junior Doctors); all of which the BMA is a member of - has written to the EC to advise that:

  • They welcome the publication of the report which clearly recognises the need for improved alcohol labelling in Europe
  • The harmonised labelling of alcoholic products would significantly, and self-evidently, improve consumers’ awareness and understanding of the ingredients and nutritional information, including energy content, of these products
  • There should be a mandatory requirement for industry producers to comply with the current regulation and to provide the listing of ingredients and nutritional information per 100ml
  • It should be mandatory for alcohol products to show unit information, alcohol guidelines, advice on alcohol-free days, a health warning message, and advice not to drink during pregnancy
  • The EU should develop its alcohol policies independently of the alcohol industry

The BMA will be working with European partners to ensure that any future alcohol labelling scheme reflects these objectives.

Read the full report


Protecting minors from the marketing of alcohol and unhealthy food & drinks

As part of the EP’s ongoing scrutiny of proposed changes to the existing EU Directive on Audio-visual Media Services, its CULT (Education and Culture) committee, which is leading the scrutiny, has adopted - 17 votes in favour, 9 against with 4 abstentions – its final report.

Despite the best efforts of the BMA and other public health campaigners, the report continues to recommend that voluntary self and co-regulation by industry for the advertising of alcohol and food high in fat, sugar and salt is sufficient to tackle the rising levels of childhood obesity and the alarming levels of youth binge drinking that persist in Europe today.

As MEPs also approved the beginning of inter-institutional trilogue negotiations, the BMA will continue to work with European partners to ensure that all decision makers are aware of the impact that their work will have on the health of Europe’s children.

Read the CULT report

Read more about our work

For further information on any of these news items, please email Paul Laffin.