CHAIR’S WELCOME

The next ENVI Committee meetings will take place in Brussels on 12-13 October 2016. We will vote inter alia on draft reports on the Regulation on mercury and an EU Action Plan against wildlife trafficking and an opinion on civil law rules on robotics. Additionally, we will consider a draft report on EU options for improving access to medicines and a number of draft opinions. We will also exchange views with the Commission on HIV/AIDs, Tuberulosis and Hepatitis C, as well as

on the implementation of the mining waste and the ambient air quality directives. Moreover, I would like to highlight that Ms Violeta Bulc, Commissioner for Mobility and Transport is invited for an exchange of views on the outcome of the ICAO Assembly negotiations in particular on the Global Market-Based Measure for reduction of aviation emissions.

Finally, ENVI will hold joint discussions with AGRI, DEVE and the FAO ahead of the World Food Day 2016 and a joint public hearing with ITRE on an mHealth Framework for Europe.

Giovanni La Via

MEETING ITEMS

Votes:

Regulation on mercury

EU Action Plan against Wildlife Trafficking

Civil Law Rules on Robotics

Considerations:

EU options for improving access to medicines

Protection of workers from the risks related to exposure to carcinogens or mutagens at work

Exchange of views:

With Violeta Bulc, European Commissioner for Mobility and Transport on the outcome of the ICAO Assembly negotiations on the GMBM

Implementation of the Mining Waste Directive

HIV/AIDs, Tuberculosis and Hepatitis C

Study on the implementation of the ambient air quality directive

Ahead of the World Food Day 2016 "Climate is changing: Food and Agriculture must too" (joint AGRI, ENVI and DEVE exchange of views with FAO)

Public hearing:

Towards an mHealth Framework for Europe (joint ITRE/ENVI Public Hearing)

Next meeting of the ENVI Committee 7-8 November 2016 (Brussels) See also the 2016 meeting dates for future meetings.

Watch online Watch the Committee meeting live on the EP web site or on Europarl TV. Past meetings are available via the EP Live multimedia library and you can also download the extracts of speeches.

More information Contact the ENVI Secretariat: envi-secretariat@europarl.europa.eu or visit the website of the ENVI Committee.

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Further information sources The EP Policy Departments publish studies, notes, information notes and workshop proceedings; to contact them, write to Poldep-Economy-Science@europarl.europa.eu. The EP Library regularly prepares briefings summarising information related to topical subjects. Find the latest updates via the links briefings and blog.

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VOTES

Regulation on mercury Vote on draft report (see meeting documents)

The Minamata Convention, agreed in 2013, is a global treaty under the United Nations Environment Programme (UNEP) to protect human health and the environment from the adverse effects of mercury and its compounds. The Convention will enter into force ninety days after it has been ratified by fifty signatories. EU ratification should make sure that the Convention enters into force for the EU and its Member States at the same time. In February 2016, the Commission tabled a proposal for a Council Decision approving the Convention on behalf of the European Union.

In parallel, this Commission proposal for a Regulation on mercury is meant to address those provisions of the Convention that are not yet covered by EU legislation. It also repeals Regulation (EC) No 1102/2008, which sets an export prohibition on mercury and several compounds, qualifies mercury from certain sources as waste and establishes rules on the storage of mercury. The proposal addresses legislative gaps concerning the import, export and uses in manufacturing and products.

The rapporteur proposes 93 amendments. The most important modifications refer to the storage of mercury waste, the alignment of export provisions with the substance restrictions for the EU market, restrictions to the use of dental amalgam, and the staged phase-out of mercury based chemicals production.

249 amendments were tabled in ENVI, mainly focussing on products and processes using mercury, dental amalgam, and mercury waste. 10 compromise amendments were elaborated. Rapporteur: Eck (GUE)

Shadows: Dantin (EPP), Paolucci (S&D), Girling (ECR), Jäätteenmäki (ALDE), Rivasi

(Greens/EFA), Pedicini (EFDD), D'Ornano (ENF)

EU Action Plan against Wildlife Trafficking Vote on draft report (see meeting documents)

The EU Action Plan presented by the Commission lists a series of measures to be taken by EU institutions and/or Member States so that wildlife trafficking can be better tackled across the EU and globally.

The draft report calls for the EU and each Member State to address wildlife crime with the greatest political urgency and highlights the need for comprehensive and

coordinated approaches across policy areas. In particular the Rapporteur calls for actions in preventing wildlife trafficking and addressing its root causes, making implementation and enforcement more effective and strengthening the global partnership. 188 amendments were tabled in ENVI focusing in particular on: the allocation of financial and human resources for the implementation of the Action Plan, regular monitoring and evaluation mechanisms, a stronger and better structured cooperation among Member States, tackling the potential illegal activities on internet, and the EU support to third countries in fighting wildlife trafficking. The rapporteur proposes 19 compromise amendments that also take in account the opinions voted in the JURI, INTA and DEVE committees.

Rapporteur: Bearder (ALDE)

Shadows: Petir (EPP), Melior (S&D), Demesmaeker (ECR), Omarjee (GUE/NGL),

Taylor (Greens/EFA), D'Ornano (ENF)

Civil Law Rules on Robotics Vote on draft opinion (see meeting documents)

This opinion will feed into JURI’s legislative initiative report pursuant to Article 225 TFEU. With the increased interactions between human, robots and artificial intelligence (AI) in diverse fields, JURI calls for a set of core fundamental values to be translated into every stage of contact between robots and humans. In his draft opinion, rapporteur acknowledges that cyber-physical systems (CPS) have numerous applications in the healthcare sector, and that the adoption of new technologies in the field of healthcare is likely to bring major benefits in terms of patient care and effectiveness of treatment, leading to increased quality of life and life expectancy. In particular, the rapporteur emphasises the role of care robots and smart technologies for providing prevention, assistance, monitoring and companionship to elderly people and people with disabilities. He also notes the growing development of medical robots and the need for early effective verification and certification procedures to assess their safety and effectiveness. 121 amendments were tabled in ENVI focusing in particular on medical and care robots, clinical trials, ethical issues and the need to preserve the patient-doctor care relationship, as well as the environmental impact of robotics. The rapporteur proposes 11 compromise amendments, covering the most important issues raised in the draft opinion, including ethical and privacy issues. Rapporteur: Buşoi (EPP)

Shadows: Gentile (S&D), Barekov (ECR), Selimovic (ALDE), Kyllönen (GUE/NGL),

Auken(Greens/EFA), Pedicini (EFDD), D'Ornano (ENF)

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CONSIDERATIONS

EU options for improving access to medicines Consideration of draft report (see meeting documents)

A number of parliamentary resolutions and Council conclusions have drawn attention to the specific nature of the pharmaceutical market, highlighting the need for debate and for measures to be taken in this regard.

The pharmaceutical industry is one of the most competitive sectors in Europe with a 20% return on investment, generating 800 000 jobs and producing an output of approximately EUR 200 billion each year. The prices of new medicines have increased during the past few decades to the point of being unaffordable for many European citizens and of creating an unsustainable situation for health care systems.

In her draft opinion, the rapporteur calls on the Commission and the Council to explore new measures to control prices, such as horizontal scanning and coordinating joint procurements and to increase cooperation between the Member States as regards price-setting procedures, in order to share information about prices, reimbursement, negotiation agreements and good practices and to avoid unnecessary administrative requirements and delays. The rapporteur also stressed that the transparency of the cost of development and clinical trials is crucial in order to set a fair price.

Rapporteur: Cabezón Ruiz (S&D) Shadows: Florenz (EPP), Barekov (ECR), Faria (ALDE), Konečná (GUE), Auken(Greens/EFA), Pedicini (EFDD), D'Ornano (ENF)

Protection of workers from the risks related to exposure to carcinogens or mutagens at work Consideration of draft opinion (see meeting documents)

Cancer is the first cause of work-related deaths in the EU. Annually, 53 % of occupational deaths are attributed to cancer, compared with 28% for circulatory diseases and 6% for respiratory diseases.

Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work sets a number of general minimum requirements to eliminate or reduce exposure for

all carcinogens and mutagens falling under its scope. Employers must identify and assess risks to workers associated with exposure to specific carcinogens and mutagens, and must prevent exposure where risks occur.

On 13 May 2016, the Commission published a proposal for an amendment to Directive 2004/37/EC, aimed at improving workers’ health protection by reducing occupational exposure to carcinogenic chemical agents, increasing the effectiveness of the EU legislation in this area and providing more clarity and a better level playing field for economic operators. The Commission suggests to revise the exposure limit values for two chemical agents considered as carcinogenic, to establish such limit values for additional ten chemical agents considered as carcinogenic and to add a new process in the list of identified processes in Annex I.

The Rapporteur proposes 21 amendments, adding a list of substances to Annex I of Directive 2004/37/EC, in order to ensure that these substances (which have been recognised as being directly and unequivocally responsible for certain cancers by the legislation of at least one Member State) are covered by the Directive. She also introduces a complementary concept of monitoring in order to ensure that these substances are subject to regular monitoring and evaluation by the Member States.

Rapporteur: Mélin (ENF)

Shadows: Petir (EPP), S&D: tbc, Girling (ECR), Meissner (ALDE), GUE: tbc Auken(Greens/EFA), Pedicini (EFDD)

EXCHANGE OF VIEWS

Implementation of the Mining Waste Directive

The Commission has been invited to present the main outcome of its report on the implementation of Directive 2006/21/EC on the management of waste from extractive industries published last September.

Directive 2006/21/EC on the management of waste from extractive industries (also known as Mining Waste Directive) aims to prevent or reduce as far as possible any adverse effects on the environment, and any resultant risks to human health, brought about as a result of the management of waste from the extractive industries. The Directive covers the management of waste resulting directly from prospecting, extraction, treatment and storage of mineral resources and from quarrying.

Pursuant to Article 18(1) of the Directive, Member States are required to provide the Commission with a report on the implementation of the Directive every three years, drawn up on the basis of a questionnaire. Article 18(1) also requires the Commission to publish a report on the implementation of the Directive on the basis of the reports submitted

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by Member States. This report covers the two first reporting periods, from 1 May 2008 to 30 April 2011 and from 1 May 2011 to 30 April 2014. This presentation has been requested in view of the drafting of the report on Implementation of the Mining Waste Directive (2006/21/EC) (2015/2117(INI), Rapporteur Mr Hölvényi).

Exchange of views with Ms Violeta Bulc, European Commissioner for Mobility and Transport on the outcome of the ICAO Assembly negotiations on the GMBM

Commissioner Violeta Bulc is invited to the ENVI committee to present the results of the 39th ICAO General Assembly as regards the proposal for a Global Market-Based Measure (GMBM) Scheme, as well as the next steps envisaged by the Commission following the Assembly decision.

The assembly took place on 27 September - 7 October 2016 in Montreal, Canada. ENVI/TRAN delegation participated in the final days of the assembly on 5-7 October.

The outcome of the negotiations on a GMBM Scheme meeting is critical to the European Parliament in view of the expiry of the "stop-the-clock" legislation, which exempts intercontinental flights from the EU ETS scheme until 31 December 2016. This exemption was agreed by the Parliament in order to give time to ICAO to decide on a global market based measure by 2016, which would be up and running as of 2020 and lead to effective reduction in CO2 emissions. The ETS regulation clearly states that decisions taken by ICAO on GMBM will condition further EU steps as regards CO2 emissions from aircraft.

Ahead of the World Food Day 2016 "Climate is changing: Food and Agriculture must too" Joint AGRI, ENVI and DEVE exchange of views with FAO

The FAO World Food Day’s 2016 theme “Climate is changing. Food and agriculture must too” resonates with the crucial time in which the day will be observed (16 October 2016), just before the next UN Climate Change Conference, COP 22 in Marrakech.

In the framework of this year’s World Food Day, the FAO is calling on countries to address food and agriculture in their climate action plans and invest more in rural development. It considers that by strengthening the resilience of smallholder farmers, food security for the planet’s increasingly hungry global population can be guaranteed and emissions reduced.

Given the theme for this year’s FAO World Food Day, a second joint AGRI-ENVI-DEVE meeting has been scheduled to allow a joint discussion between the committees concerned. (The first meeting with this format took place last year on 13 October 2015).

HIV/AIDs, Tuberculosis and Hepatitis C

Exchange of views with the Commission Since 2008, the European Centre for Disease Prevention and Control (ECDC) and the Commission have been producing several action plans to combat HIV/AIDS and tuberculosis, both in in the European Union and in neighboring countries. In March 2014, the Commission adopted the Action Plan on HIV/AIDS in the EU and neighboring countries: 2014-2016. Among the key issues identified, HIV/AIDS co-infections such as tuberculosis (TB) and viral hepatitis as some of the leading causes of death for people living with HIV, particularly among drug users. For instance, HIV is a major risk factor for developing TB, and TB is responsible for more than a quarter of deaths among people living with HIV. Particularly in Eastern European, there is need to increase integrated prevention and treatment such as access to harm reduction methods, and antiretroviral treatment, particularly in prisons. This exchange of views with the Commission will allow to address possible future initiatives on HIV/Aids, Tuberculosis and Hepatitis C, and discuss the ongoing challenges linked to the nature of these epidemics in the EU and in the Eastern Partnership countries. In particular, the question of a possible integrated policy framework for 2016-2020 on HIV, Tuberculosis and Hepatitis C could be raised.

Study on the implementation of the ambient air quality directive Exchange of views with the Commission

The Ambient Air Quality Directive sets thresholds for certain pollutants in ambient air to protect human health and the environment. The pollutants concerned are sulphur dioxide (SO2), nitrogen dioxide (NO2) and other nitrogen oxides, particulate matter PM10 and PM2.5, lead (Pb) in PM10, carbon monoxide (CO), benzene (C6H6) and ozone (O3).

As thresholds for particulate matter and nitrogen dioxide are exceeded in several Member States, ENVI coordinators decided on 25 June 2015, to commission a study on the implementation of the Ambient Air Quality Directive (AAQD - Directive 2008/50/EC).

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The aim of the study was to analyse air pollution hotspots in Europe and describe the infringement procedures launched by the European Commission against Member States in non-compliance. The study analysed four hotspots (Milan, London, Krakow and Plovdiv in Bulgaria) in more detail with respect to pollutant levels and approaches to air quality improvement. The key findings of the study, which was published in July 2016, are the following:

About two thirds of the Member States are currently in non-compliance with PM10 (particulate matter 10 micrometres or less) and nitrogen dioxide (NO2) limit values, and one fifth exceeds the PM2.5 (particulate matter 2.5 micrometres or less in diameter) target value.

Infringement procedures were launched by the European Commission against a high number of Member States and several cases were referred to the Court of Justice of the European Union. However, no judgement was passed so far that might lead to accelerated compliance.

Domestic heating, traffic and industry are major sources of PM10 and PM2.5, whereas NO2 is mainly caused by emissions from (diesel) vehicles.

Stringent measures to achieve compliance have been and will be implemented in some but not all the cities.

Except for some local hotspots, full compliance is expected for 2030 on a European level, which is considerably later than envisaged in the Clean Air Policy Package.

The full study can be accessed here. The Commission has been invited

for an exchange of views to respond to the main findings of the study.

PUBLIC HEARING

Towards an mHealth Framework for Europe

Joint ITRE/ENVI Public Hearing

The joint public hearing on "Towards an mHealth Framework for Europe" aims to provide a constructive input into a possible new proposal from the Commission. mHealth solutions cover various technological solutions, that measure vital signs such as heart rate, blood glucose level, blood pressure, body temperature and brain activities. Prominent examples of apps are communication, information and motivation tools, such as medication reminders or tools offering fitness and dietary recommendations. The spread of smartphones as well as 3G and 4G networks has boosted the use of mobile apps offering healthcare services. The availability of satellite navigation technologies in mobile devices provides the possibility to improve the safety and autonomy of patients. Through sensors and mobile apps, mHealth allows the collection of considerable medical, physiological, lifestyle, daily activity and environmental data. This could serve as a basis for evidence-driven care practice and research activities, while facilitating patients' access to their health information anywhere and at any time. mHealth could deliver high-quality healthcare, and enable accurate diagnosis and treatment. Mobile apps can encourage adherence to a healthy lifestyle, resulting in more personalised medication and treatment.

The patients could manage their health actively, living more independent lives in their own home environment thanks to self-assessment or remote monitoring solutions and monitoring of environmental factors such as changes in air quality that might influence medical conditions.

This hearing will host four expert speakers representing industry, research and Member States with a view to increase the understanding of the issues at stake and to analyse how to achieve objectives related to the mHealth development in Europe in legal aspects, in institutional dimensions, in some requirements for interoperability and standardization.

NEWS FROM THE POLICY DEPARTMENT

Recent Publications

•EU Accession to CITES – Main Issues and Positions for the 17th

COP

Proceedings of the workshop on "EU’s pesticide risk assessment

system: the case of glyphosate"

Proceedings of the workshop on EU options for Improving Access to Medicines

Upcoming Publications Briefing - Key studies on Public health

Comparative study on the differences between the EU and US legislation on emissions in the automotive sector (for EMIS)

Proceedings of the Workshop on Delivering and Enforcing the EU Action Plan against Wildlife Trafficking

Upcoming event 12 October 2016, 12:30 - 14:45, Workshop on "Living with a

neurological brain disorder: Taking control of your life". Altiero Spinelli, A1G-2

29 November 2016, 12:45-14:45, Workshop on "Exchange of good practice in the field of health promotion and primary prevention". Paul-Henri Spaak 5B001 (ENVI Working Group on Health)

To request hard copy of publication please contact: Poldep-Economy-Science@ep.europa.eu

NEWS FROM THE AGENCIES

European Environment Agency (EEA)

Electric vehicles and the energy sector - impacts on Europe's future emissions. A fundamental change within the road transport sector is required if Europe wants to achieve its objective of a long-term transition to a low-carbon European economy. Electric vehicles charged from

renewable sources can reduce future emissions of greenhouse gases and air pollutants from road transport. This briefing presents the key implications for emissions and Europe's energy system arising from the potential wide-scale use of electric cars in 2050. More

European Chemicals Agency (ECHA) ECHA is consulting on proposals to identify six chemicals as substances of very high concern (SVHC), including bisphenol A (BPA), 4-tert-butylphenol and trimellitic anhydride. The deadline for comments from interested parties on the identity of the

substances, PBT or vPvB properties as well as uses, volumes per use, exposure, alternatives and risks of the substance is 21 Oct.2016. More

European Food Safety Authority (EFSA) EFSA is to release the raw data used in its recent

evaluation of glyphosate. Following a public access to document request, the data will be shared with a group of Green MEPs. According to

EFSA, this move will increase the transparency of the glyphosate evaluation, while respecting EFSA's obligations regarding the protection of commercially sensitive information. More

European Centre for Disease Prevention and Control (ECDC)

- On a proposal from the ENVI Committee the Parliament's Conference of Presidents nominated on 15 September new EP representatives on the ECDC Management Board. The two new full representatives are: Ms Mazej (Slo) and Ms Koppa (Gr), both ex-MEPs.

Mr António Correia de Campos (Pt) (also an ex- MEP) has been nominated as an alternate member. Their term of office started on 28 September 2016 and will be four years. - Whole Genome Sequencing (WGS) as a means of public health surveillance and outbreak investigation will bring important innovations in the future. More

European Medicines Agency (EMA)

EU-US collaboration to boost medicine development for rare diseases. EMA and the US Food and Drug Administration have set up a new working group on rare diseases to share experiences and best practices on each other’s regulatory approach to the development of

medicines for these diseases, including the design of clinical trials and scientific evaluation of medicines. More

About the editor European Parliament, Directorate General for Internal Policies of the Union, Secretariat of the Committee on the Environment, Public Health and Food Safety - Responsible administrators: Tihana Vujatović, Hans-Christian Eberl. Responsible assistants: Irena Aramina, Marie-Christine Della Faille.

Legal disclaimer The items contained herein are drafted by the ENVI Committee Secretariat and are provided for general information purposes only. The content is indicative and subject to changes. The opinions expressed in this document are the sole responsibility of the author(s) and do not necessarily represent the official position of the ENVI Committee. The newsletter contains links to websites that are created and maintained by other organisations. The ENVI Committee does not necessarily endorse the views expressed on these websites.