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Press Release: Stakeholders celebrate key role in new data regulation

European Parliament, Strasbourg: December 16th:  Details of the General Data Protection Regulation are about to be made public and the Brussels-based European Alliance for Personalised Medicine (EAPM) welcomes the inclusion of many suggestions and recommendations it has made during the process. 

The Alliance has contributed hugely to a piece of legislation that saw around 4,000 amendments to the original draft as it developed and changed.   Now the ‘trilogue’  of European Parliament, Council and Commission have reached agreement and its impact in the arena of health, and especially health research, will be immense.   

The Alliance’s Didier Jacqmin said: 'The mathematics are simple – better preventative and/or better ongoing treatment – using vital data  – will keep patients out of expensive hospital beds, allowing them to remain in the workplace during treatment contributing to the economy rather than helping to drain it.’  

Over the past three years, EAPM, alongside key members and partners including ESMO, EORTC, EPF, EHA, EAU, Science Europe and Wellcome Trust, tabled 10 key legislative amendments to Parliament through the LIBE, ITRE and ENVI Committees, all of  which were supported in plenary.  

This was made possible as the Alliance held a central role in bringing major stakeholders together to present concerns from platforms representing patients, researchers, scientists, healthcare professionals and more.   Down the years, the Alliance has organised many stakeholder meetings on Big Data and data protection, including one in the European Parliament in collaboration with Wellcome Trust, FEAM and Science Europe. 

This was designed to convey key messages about the need for data to be shared in a way that does not block vital research.   This was followed by numerous meetings with MEPs on critical points, augmented by a document for all new Members joining the latest legislature that highlighted issues relating to data protection, clinical trials and research.   

That document was strengthened by an EAPM-organised roundtable with new Parliamentarians to explain the Alliance position and garner their support. The roundtable was backed up by numerous briefing documents prepared for EAPM members.   In February of 2015, the Alliance hosted a meeting with Member States regarding the discussions that were taking place at the Council, following it up with written communications to relevant ministries. 

Meanwhile, Big Data and the data protection regulation have, of course, always played a part of EAPM’s Annual Conference.   And, as recently as this month, the Alliance was able to answer Member State questions on various data-related issues while also seeing its continuous work reflected in the landmark Luxembourg Council Conclusions on personalised medicine.   

Several of the key points that the Alliance has raised across the course of the regulation being formulated can be seen below.   

Paragraph 26 of the regulation calls for ‘a number, symbol or particular assigned to an individual to uniquely identify the individual for health purposes,’ and this will be vital to ensure that valuable medical data can be collected, stored and shared.   

This came after many strong calls to strike a sensible balance between protecting the patient and freeing up vital data to progress research and personalised medicine during this generation and those that will follow.   

Paragraph 42b, meanwhile, includes safeguards acknowledging that ‘The processing of special categories of personal data may be necessary for reasons of public interest in the areas of public health without consent of the data subject. But ‘such processing of personal data concerning health for reasons of public interest should not result in personal data being processed for other purposes by third parties such as employers, insurance and banking companies’.   

And paragraph 53 states that: ‘A natural person should have the right to have personal data concerning them rectified and a 'right to be forgotten' where the retention of such data is not in compliance with this Regulation or with Union or Member State law to which the controller is subject’, but it adds that ‘the further retention of the data should be lawful where it is necessary’ and gives the example ‘for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller, for reasons of public interest in the area of public health, for archiving purposes in the public interest, or scientific and historical research purposes’   

EAPM campaigning has also resulted in influential input into many other paragraphs, such as Paragraph 88, which concludes that ‘For scientific and historical research purposes or statistical purposes, the legitimate expectations of society for an increase of knowledge should be taken into consideration.’   

The Alliance undertook a great deal of work in this area, including hosting workshops in the European Parliament and at the ESMO Congress.  EAPM also worked hard on research in various diseases and the clear need for registries. 

This is reflected in paragraph 125aa, while paragraph 126 states that: ‘For the purposes of this Regulation, processing of personal data for scientific research purposes should be interpreted in a broad manner’ which includes ‘for example, technological development and demonstration, fundamental research, applied research, privately funded research and in addition should take into account the Union's objective…of achieving a European Research Area’.   

It adds that: ‘Scientific research purposes should also include studies conducted in the public interest in the area of public health. To meet the specificities of processing personal data for scientific research purposes specific conditions should apply in particular as regards the publication or otherwise disclosure of personal data in the context of scientific research purposes.’   

This is a distinct reference to separating the different types of data, eg for health research rather than data held by the likes of Facebook or Google and acknowledges the specifics of health research data.   Paragraph 126b adds that: ‘For the purpose of consenting to the participation in scientific research activities in clinical trials the relevant provisions of Regulation (EU) No. 536/2014 of the European Parliament and of the Council should apply.’   

This clearly links clinical trials and data protection and acknowledges, once again, that health data is not the same as that held on, for instance, social media sites.   

The Regulation also states that ‘processing is necessary for archiving purposes in the public interest, or scientific and historical research purposes or statistical purposes in accordance with Article 83(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject’.   

This sensible measure is one that EAPM has long campaigned for, as is the inclusion of a recognition of the difference between anonymised and pseudo-anonymised data, and the statement that ‘where personal data are processed for scientific and historical research purposes or statistical purposes, Union or Member State law may provide for derogations from the rights referred to in Articles 15, 16, 17a and 19’.   

It adds the proviso ‘subject to the conditions and safeguards referred to in paragraph 1 in so far as such rights are likely to render impossible or seriously impair the achievement of the specific purposes, and such derogations are necessary for the fulfilment of these purposes’ but this essentially allows Member States to act on exceptions in certain cases. 

Once again, it is clear that the hard work of EAPM, alongside its members and partners, has had a key role to play in the sections of this regulation that deal specifically with health and health research.  

The Alliance believes that this will have a positive impact on the health of 500 million potential patients across 28 Member States as well as that of their children, grandchildren and all the generations that will follow.   

Next formal steps are:   

  • LIBE committee (Parliament) vote on Thursday at 0930-1000 CET   
  • Coreper (Member State ambassadors) to vote on Friday or Monday.   
  • These votes will indicate informal political agreement on the Regulation. 
  • The Regulation will then go for legal linguistic checks ahead of formal votes in Parliament plenary and the Council of Ministers next year.
Author: Denis Horgan