Copy
This is the monthly newsletter on Public Affairs sent by ESTRO to national societies
View this email in your browser


ESTRO introduces a new information tool: a monitoring service on Oncopolicy to keep up-to-date the national societies with this evolving landscape.
 

Oncopolicy refers to all legislative, regulatory and political decisions and programmes that impact on cancer patients and those delivering their care. Alerts and blasts will be published by ESTRO monthly, to inform you on the relevant EU policy developments, news on EU research and public health policy, relevant events...  We warmly suggest you to share this information with your members and to use it as support for positioning your society and discipline.
 
CONTENT

EU RESEARCH POLICIES
  • JRC annual report – focus on cancer
  • Data Protection Regulation and Health Research
  • Clinical Trials Regulation
EU PUBLIC HEALTH POLICIES
  • eHealth and mHealth – latest EU activities
  • European Guide for Quality National Cancer Control Programmes
  • Medical Devices Regulations

1. JRC annual report – focus on cancer


The Joint Research Centre (JRC) latest Annual Report provides an overview of the JRC's main activities in 2013. There are several areas of the JRC’s work of interest for ESTRO, one of those being the harmonisation of cancer information systems.

 
The JRC – in partnership with DG SANCO- launched the process of harmonising cancer data across Europe bringing together key cancer registry stakeholders and developing common protocols for quality checks of cancer data. The JRC now operates the European Network of Cancer Registries (ENCR), representing over 200 cancer registries in Europe. Cancer registries enable the Commission to report on cancer incidence in Europe, to steer and monitor cancer policy interventions as well as act as a reference for epidemiological research in Europe.

As part of this area of work, the JRC and the ENCR have recently started to publish a series of fact sheets on cancer diseases burden in Europe. They inform about regional differences in incidence rates and gender patterns over the last decades. They also provide a summary of screening and prevention methods and an overview of causes and risk factors. The first two cancer types covered in this series are colorectal and prostate cancers. New factsheets covering other types of cancer will be published on a monthly basis. Forthcoming topics are: lung, breast, malignant melanoma of skin and cervix uteri cancers.

2. Data Protection Regulation and Health Research

 
In 2012, and with discussions ongoing during the whole 2013, the European Commission published the draft proposal of the General Data Protection Regulation (DPR), to regulate the processing and movement of personal data. The DPR wants to protect the EU citizens and strengthen privacy rights, however it has dangerous aftermaths for health and research: the regulation has a very broad scope, including the use of personal data in health research and tightens up the burden for using patients’ data. If the Parliament’s amendments are included in the final DPR they would have a serious negative impact on the ability to conduct research with personal data in the EU.


Background
In January 2012 the European Commission published a proposal for a General Data Protection Regulation (DPR) to replace the current Data Protection Directive of 1995 (95/46/EC). This represents a major reform of the EU legal framework on the protection of personal data. As a Regulation, the DPR will be directly binding throughout all 28 Member States and does not need to be transposed into national law.
 
The DPR covers the use of personal data in research and aims to harmonise data protection law within the EU. It will strengthen individual rights and tackle the challenges of globalisation and new technologies. It has a very broad scope, including the use of personal data in health research.
 
The draft Regulation published by the Commission in January 2012 included important articles that would provide a proportionate mechanism for protecting privacy, while enabling health research to continue. These proposals were welcomed across the research community. The Commission’s proposal (Article 83.1) enables personal data to be processed for historical, statistical and scientific research without the need for consent, provided that it fulfils the following requirements:
  • that personal data should not be used if anonymous data would be sufficient.
  • if possible, any identifying information should be kept separately from other information.
 
While the Commission’s proposal sets out a positive position for research, it would still benefit from amendments to clarify and strengthen the text.
 
The proposal is currently going through the legislative process, which involves the European Parliament and Member State governments through the Council of Ministers.

 
Position of Parliament
The Civil Liberties and Home Affairs (LIBE) Committee has led the scrutiny of the Regulation within European Parliament, which includes proposing amendments to the text. In January 2013, the rapporteur of the LIBE Committee proposed amendments that would have severe consequences for health research, if accepted. Many Members of the European Parliament (MEPs) tabled positive amendments that would strengthen and clarify the text. However, in the committee’s discussions on the DPR they developed amendments on research that were very similar to the rapporteur’s damaging proposals. The Committee adopted all the compromise amendments on 21 October 2013.
Parliament voted on the LIBE Committee’s amendments to the Regulation in plenary in March 2014. The amendments were voted on in a single block vote and were adopted by an overwhelming majority. This vote consolidates Parliament's position ahead of the next stage of the process. However, in the plenary debate a number of MEPs spoke in support of health research and noting their concerns with these amendments
 
If the Parliament’s amendments are included in the final DPR they would have a serious negative impact on the ability to conduct research with personal data in the EU. These amendments would:
  • Prevent the use of any identifiable data in research without consent.
  • Make the use of pseudonymised health data in research without specific consent very difficult, if not impossible. This would include data from many cohort studies, biobanks and routine healthcare data.
 
Position of the Council of Ministers
Council discussions are currently ongoing and they have not yet agreed a position on research or any other aspects of the text. It is unclear when Council will agree their position or ‘general approach’, which allows them to start the next stage of the legislative process.
 

Next steps in the legislative process
The amendments adopted by Parliament become their position in the next stage of the legislative process. However, the Council of Ministers still needs to agree a position and authorise the Presidency to negotiate on its behalf. Consequently, there is still an opportunity to ensure that the Council adopts a strong positive position on research.
 
The next stage will be the ‘trialogue’ process when the European Parliament, Council of Ministers and European Commission negotiate a final draft to vote on. Before and during the trialogue process the Council of Ministers and the Commission can be encouraged by stakeholders to resist the Parliament’s amendments on research. In the Parliament’s plenary debate, Commissioner Viviane Reding (DG Justice) said that she would like the Commission proposal on research to be maintained since it strikes a balance between protecting individuals while facilitating “indispensable research”. She said that she hopes the negotiations will find “equilibrium” on this issue.
 
The timelines for trialogue are currently unclear. However, the negotiations will continue into the next Parliament following elections in May 2014. Once adopted the Regulation would come into force in two years.
 

Further information
A number of position statements have been issued by various stakeholders as the legislation has progressed.
ESTRO joined efforts with numerous partners: ESMO, ECCO, EORTC… As of October 2013, common efforts have been put in place in contacting the relevant MEPs. Meetings took place during the last months of 2013 to share information among oncology societies and to support advocacy actions, each partner acting according to its channels. A common letter has been drafted, with a plea to the National Authorities and MEPs, in order to share the same message within Europe. The partner societies advocate mainly for the concept of broad consent â€“ the patient would be given the option to give a “one-time”, specific, informed and explicit consent to have their data processed within the framework of health research, and the right to withdraw their consent at any time – and the exemption from consent for population-based disease registries.
 

ESTRO’s Recommendations to the National Societies
National Societies to keep on liaising with Justice Ministries in Member States and Justice Permanent Representations in Brussels to encourage resisting the Parliament’s amendments on research.
Please contact the ESTRO office (cgasparotto@estro.org) to receive the letter targeted to National Authorities and MEPs, endorsed with the logos of the partner societies. The letter highlights the hazards of the GDPR as it is, and advocate for a change, specifically on the articles referring to the use of medical data and cancer registries.
 
3. Clinical Trials Regulation
 
Between 2007 and 2011 the number of applications for clinical trials decreased by 25% in the EU. The new proposal from the European Commission for a Regulation on Clinical Trials  published in July 2012 aims to make the EU more attractive for clinical research, by setting a uniform framework for the authorisation of clinical trials in Europe. 

 
Background
The proposed Clinical Trials Regulation aims concretely to cover the shortcomings of the current Clinical Trials Directive in place (2001/20/EC) by setting a uniform framework for the authorisation of clinical trials in Europe.
 
The new Regulation provides for simplification of current rules, featuring a ‘one-stop’ portal and database for submitting applications, a flexible assessment procedure, simplified reporting systems and simpler rules for running multinational trials.
 
The proposed Regulation also foresees specific provisions for the transparency of information related to clinical trials. It aims for all trials to be registered and their results reported on a publicly accessible database (EudraCT). In the negotiations, the European Parliament amended the draft to improve transparency, by requiring detailed Clinical Studies Reports to be published publicly once a decision on marketing authorisation has been made. Fines would be imposed on sponsors who do not comply with these requirements.
 

State of the Legislative Procedure
On 14 April the Council approved the draft regulation
The Regulation is now adopted and will enter into force 20 days following its publication in the Official Journal of the European Union and apply six months after an EU portal for the submission of data on clinical trials and a EU database identifying each clinical trial have become fully functional (but not earlier than two years after the regulation’s publication).
 

ESTRO’s Recommendations to the National Societies
National Societies to monitor implementation 

4. eHealth and mHealth – latest EU activities


The Commission launched earlier this month a consultation on mobile health (mHealth). The Commission wants to gather opinions on how to improve health services provided via mobile phones, tablets, patient monitoring devices, etc. 

 
Consultation on mHealth
mHealth forms part of the broader concept of eHealth, where Information and Communication Technologies (ICT) are used to improve health products, services and processes.
This consultation was foreseen in the Commission’s eHealth Action Plan 2012-2020  and is accompanied by a  Staff Working Document aiming at helping stakeholders to determine whether certain EU legislation  (such as data protection, medical devices or consumer protection) applies to their health apps or not.
The consultation is open until 3rd July and can be accessed here.


Updates on eHealth
eHealth is a priority area of work for the European Institutions and is perceived as a major means to boost efficiency of the European health systems.
Concretely, ICT implementation in the health sector is expected to:
  • increase quality of care and efficiency
  • reduce operating costs of clinical services
  • reduce administrative costs
  • enable entirely new modes of care.
 
The Commission published on 11 April four reports prepared by the ‘eHealth Stakeholder Group’ (eHSG). The reports aim at giving information on the state of play of the issues addressed whilst providing the Commission with recommendations.

The reports are available under the following links: The reports will also be shared with the eHealth Governance Initiative, which gives technical support to the network of Member States representatives in the field of eHealth.


ESTRO’s Recommendations to the National Societies
National Societies to consider responding to the consultation on mHealth bringing forward the specific needs and expectations of radiation oncology.

5. European Guide for Quality National Cancer Control Programmes

 
One of the main deliverables of the EPAAC Joint Action has now been published: the European Guide for Quality National Cancer Control Programmes.

 
The European Guide for Quality National Cancer Control Programmes aims at:
-        providing a synthesized description of the broad range of cancer control services that may be offered through national health systems
-        proposing a list of indicators that countries may consider in order to improve the monitoring and evaluation of their plans
-        promoting some convergence in national approaches to planning
Consecutively to EPAAC, the CANCON Joint Action (European Guide on Quality Improvement in Comprehensive Cancer Control) was launched on 24 February 2014. ESTRO is a CANCON collaborative partner.


ESTRO’s Recommendations to the National Societies
National Societies to disseminate to all their members the European Guide for Quality National Cancer Control Programmes.

6. Medical Devices Regulations


On 26 September 2012, the European Commission proposed the revision of the medical devices directives, which included a Communication,  and two proposals for Regulations, one for medical devices and one for in vitro diagnostic medical devices.
The core of the new legislation is therefore to put in place a specific authorisation procedure for these products covering also some other technical aspects of medical devices such as for instance the nature of chemicals present in these devices.

 
Background
These proposals for Regulations, one for medical devices and one for in vitro diagnostic medical devices, came forward after the breast implants and metal-on-metal hip implants scandals, which significantly speeded up the work of the Commission on this regulatory file.
Unlike pharmaceuticals, medical devices -a family of products ranging from contact lenses to pacemakers- do not need to undergo an authorization process to be placed in the EU market. Instead, there are 80 private companies which award the manufactures with the ‘CE marking’ after an evaluation of the safety and effectiveness of the device.
The core of the new legislation is therefore to put in place a specific authorisation procedure for these products covering also some other technical aspects of medical devices such as for instance the nature of chemicals present in these devices.
 

Parliament vs. Commission: positions
The EP has toughened the Commission’s proposal to enhance control and safety requirments. MEPs have introduced stricter criteria for the monitoring of devices as well as the strengthening of the competences of the evaluating bodies. For high risk devices,  the EP rapporteur initial intention was to have a centralized body assessing safety and efficacy, but at the end the EP agreed on the creation of ‘specialized notified bodies’ designated by the European Medicines Agency and subjected to stricter requirements.
Another novelty of the EP proposal is that manufacturers would be obliged to take liability insurances with sufficient coverage to ensure that patients are compensated for any damage resulting of a faulty medical device. MEPs have also added provisions on transparency of the information resulting of clinical investigations. 
Finally, the nature of chemicals present in medical devices has been the focus of much attention while passing through the scrutiny of the European Parliament: MEPs have upgraded the restrictions on carcinogenic, mutagenic, reprotoxic (CMR) and endocrine disrupting chemicals (EDCs) and loosen restrictions on nanomaterials compared to the Commission’s proposal. 
Concretely, medical devices or parts that come into contact with the body shall not contain concentrations above 1% by weight of CMR and EDCs and their use will only be approved through a delegated act for a period not exceeding 4 years when no safe alternative exist.
For devices containing nano-materials the Commission had proposed that all devices should go through a stricter pre-market authorization process, unless the substances were encapsulated in such a way that they could not be released into the patient’s body. MEPs considered that this measure was a threat to European medical innovation given that too many harmless products would have to unnecessarily pass the strict authorization process. Instead, MEPs opted for the strict authorization process applying only to devices which intentionally release nanomaterials into the body.
The Parliament has also added a provision on animal testing, by which animal use should be minimized and tests on vertebrates only undertaken as last resort. The EP calls the Commission to lay down rules to prohibit duplication of tests and studies on vertebrates.
Regarding in vitro diagnostic devices (e.g. diabetes test, HIV, pregnancy tests, DNA testing…), MEPs have called for review through ethics committees and to clarify concepts such as ‘informed consent’ and ‘genetic counselling’.
 

State of the legislative process
The European Parliament adopted its first reading on the medical devices and the in-vitro medical devices regulations on  2 April 2014. The report had already been approved in plenary in October 2013, but the final vote on the legislative resolution was postponed in order to allow negotiations to start with the Council in order to possibly reach a 1st reading agreement.  However, the Member States have so far failed to agree and a common position has not been reached as yet.  The newly elected Parliament once in place will need to await  the formal Common Position from the Council before starting the  2nd reading procedure.  


ESTRO’s Recommendations to the National Societies
National societies to monitor the next legal steps and assess impact at national level.
The ESTRO Public Affairs newsletter has been prepared in collaboration with Interel.
The full version of the Interel report / Volume 1 / May 2014 issue is available on the ESTRO website.

Read the latest report >

If you have any question on public affairs, please contact Chiara Gasparotto at the ESTRO office: cgasparotto@estro.org
Facebook
Facebook
Twitter
Twitter
Website
Website


Copyright © 2014 ESTRO, All rights reserved.


unsubscribe from this list    update subscription preferences