The document provides an overview of recent and upcoming EU healthcare policy developments. Key points include:
1) Disagreements among MEPs on the clinical trials regulation regarding transparency of results.
2) Plans to adopt new rules on medical devices and in vitro diagnostic devices by November to improve safety.
3) Ongoing negotiations on pricing and reimbursement of medicines and revisions to the Tobacco Products Directive.
4) A new symbol will identify medicines undergoing additional monitoring and rules aim to improve labelling of hazardous chemicals.
5) An animal testing ban for cosmetics has fully entered into force and €144 million in funding was provided for rare disease research.
Pharma Maket Access - Southeast Europe & TurkeyZdravko Mauko
Key figures about pharmaceutical market access in southeast Europe and Turkey. Summary about market authorisations, pricing and reimbursement for Croatia, Serbia, Bosnia and Herzegovina, Macedonia, Kosovo, Albania, Bulgaria, Romania and Turkey
EU Food Regulation on Additives, Novel Foods and Food Contact MaterialsDaniele Pisanello
The presentation has been used within the EIPA's Seminar "Introduction to the fundamentals of EU Food Law: principles, procedures & main regulatory components", 7 and 13 of Luly 2016, on behalf of European Commission, DG Translation.
It provides an introduction to specific legal standards relating to food additives, novel foods and food contact materials.
Pharma Maket Access - Southeast Europe & TurkeyZdravko Mauko
Key figures about pharmaceutical market access in southeast Europe and Turkey. Summary about market authorisations, pricing and reimbursement for Croatia, Serbia, Bosnia and Herzegovina, Macedonia, Kosovo, Albania, Bulgaria, Romania and Turkey
EU Food Regulation on Additives, Novel Foods and Food Contact MaterialsDaniele Pisanello
The presentation has been used within the EIPA's Seminar "Introduction to the fundamentals of EU Food Law: principles, procedures & main regulatory components", 7 and 13 of Luly 2016, on behalf of European Commission, DG Translation.
It provides an introduction to specific legal standards relating to food additives, novel foods and food contact materials.
APIFARMA, the Portuguese pharmaceutical industry assocation, holds a series of conference throughout they year. OHE's Jorge Mestre-Ferrandiz, an expert on pricing and reimbursement (P&R) in Europe, was the lead speaker at the October 2014 conference on access to innovation. His presentation covers existing and potential approaches to evaluating new medicines as a condition for P&R in France, Germany and the UK.
The long awaited new novel food regulation has finally made its very welcome arrival to update and streamline the approach to gaining approval for new food and food ingredients in the EU. It’s main benefits are to clarify the scope and definitions, to introduce a centralised procedure and to introduce a notification process for “traditional foods from third countries”. Whilst it also introduces a generic “Union List”, it also allows proprietary submissions in some cases. Although the actual legal enactment is not until January 2018, there is so much to do in the meantime. January 2016 webinar now available on demand: http://www.intertek.com/knowledge-education/new-novel-food-regulation-transition-begins/
This presentation was made by Kristina Garuoliene, Lithuania, at the 3rd Health Systems Joint Network meeting for Central, Eastern and South-eastern European Countries held in Vilnius, Lithuania, on 25-26 April 2019
Hazardous Chemicals in Products - Resources for Healthy Children v2zq
Hazardous Chemicals in Products - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~
Presentation by Dana Spinant (DG JUST, European Commission) on the occasion of the EESC hearing on New Psychoactive Substances (Brussels, 27 November 2013)
“Key messages for policy makers” presented at the "H2020 projects for evidence-based agricultural related policies" roundtable at the European Parliament on the 25th April 2018.
Do not hesitate to contact EMPHASIS project through:
Facebook https://www.facebook.com/emphasisproject/
Twitter https://twitter.com/EmphasisProject
Email emphasisproject@gmail.com
Website http://www.emphasisproject.eu
Slideshare https://www.slideshare.net/EMPHASISPROJECT/
Legal requirements for contact materials
Prof. Roberto Massini
Contents:
• European legislation
• Supplementary Italian legislation
• US Federal legislation
• Conclusions
As the UK Government prepares to publish the 'Repeal Bill' to give legal effect to the UK's withdrawal from the European Union, this paper looks at the possible implications for pharmaceuticals regulation. The paper by Andrew Hollingsworth gives a short overview of the current EU regulatory framework and looks at some of the options and potential outcomes in the forthcoming UK-EU negotiations.
APIFARMA, the Portuguese pharmaceutical industry assocation, holds a series of conference throughout they year. OHE's Jorge Mestre-Ferrandiz, an expert on pricing and reimbursement (P&R) in Europe, was the lead speaker at the October 2014 conference on access to innovation. His presentation covers existing and potential approaches to evaluating new medicines as a condition for P&R in France, Germany and the UK.
The long awaited new novel food regulation has finally made its very welcome arrival to update and streamline the approach to gaining approval for new food and food ingredients in the EU. It’s main benefits are to clarify the scope and definitions, to introduce a centralised procedure and to introduce a notification process for “traditional foods from third countries”. Whilst it also introduces a generic “Union List”, it also allows proprietary submissions in some cases. Although the actual legal enactment is not until January 2018, there is so much to do in the meantime. January 2016 webinar now available on demand: http://www.intertek.com/knowledge-education/new-novel-food-regulation-transition-begins/
This presentation was made by Kristina Garuoliene, Lithuania, at the 3rd Health Systems Joint Network meeting for Central, Eastern and South-eastern European Countries held in Vilnius, Lithuania, on 25-26 April 2019
Hazardous Chemicals in Products - Resources for Healthy Children v2zq
Hazardous Chemicals in Products - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~
Presentation by Dana Spinant (DG JUST, European Commission) on the occasion of the EESC hearing on New Psychoactive Substances (Brussels, 27 November 2013)
“Key messages for policy makers” presented at the "H2020 projects for evidence-based agricultural related policies" roundtable at the European Parliament on the 25th April 2018.
Do not hesitate to contact EMPHASIS project through:
Facebook https://www.facebook.com/emphasisproject/
Twitter https://twitter.com/EmphasisProject
Email emphasisproject@gmail.com
Website http://www.emphasisproject.eu
Slideshare https://www.slideshare.net/EMPHASISPROJECT/
Legal requirements for contact materials
Prof. Roberto Massini
Contents:
• European legislation
• Supplementary Italian legislation
• US Federal legislation
• Conclusions
As the UK Government prepares to publish the 'Repeal Bill' to give legal effect to the UK's withdrawal from the European Union, this paper looks at the possible implications for pharmaceuticals regulation. The paper by Andrew Hollingsworth gives a short overview of the current EU regulatory framework and looks at some of the options and potential outcomes in the forthcoming UK-EU negotiations.
TIMELINE
PHARMACOVIGILANCE STAKEHOLDERS
ERMS – RECOMMENDATIONS 2005 – KEY CHANGES
2006 CONSULTATIONS – 2008 PROPOSALS
NEW DIRECTIVE 2010/84/EU
PHARMACOVIGILANCE
New regulation (EC) No 726/2004
PHARMACOVIGILANCE OF HUMAN MPs
PHARMACOVIGILANCE OF VETERINARY MPS
MILESTONES 2011-2012
REGULATION (EU) 520/2012
ICH GUIDELINES
GPvP GUIDELINES
MILESTONES – FURTHER DEVELOPMENT
European Union Action in the field of Rare Diseases. Antoni Monserrat Moliner. Presentation of the Strategy in Rare Diseases of the National Health System. (Madrid, Ministry of Health and Social Politics, 2009).
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536&from=EN
What is Efficacy
Why Efficacy is required for Herbal products
How Efficacy of Herbal products ensured
What are the various avenues of determining efficacy
Annual report 2015 - European Directorate for the Quality of Medicines & Heal...Council of Europe (CoE)
This publication presents the work carried out in 2015 by the European Directorate for the Quality of Medicines & HealthCare, Council of Europe, highlighting its particular achievements.
Similar to Insights: EU Healthcare Policy March 2013 (20)
Is Technology Removing the ‘Care’ from Healthcare?MSL
We live in a digital age that is transforming healthcare. But, how does the industry need to adapt to fully engage in the digital future of the NHS?
New solutions are critical to embrace the benefits of improved digital technology in personalised care, while ensuring that patients are not marginalised in the process.
An enquiry led by US cardiologist, geneticist and digital medicine expert, Dr Eric Topol, explores how to support the deployment of digital healthcare technologies throughout the NHS.
MSL partnered with research firm Toluna to survey 1,846 marketing and communications leaders from Brazil, China, France, Germany, India, Italy, Poland, United Kingdom and the United States.
Powered by AI: Communications and Marketing in the Algorithm AgeMSL
MSL partnered with research firm Toluna to survey 1,846 marketing and communications leaders from Brazil, China, France, Germany, India, Italy, Poland, UK and US. We partnered with our colleagues at sister agency Publicis.Sapient who are experts in counselling companies and brands on the AI revolution.
A look inside the endless debate between traditional and digital media.
For more information write to Joshua Gardner, Vice President & North American Lead, Global Energy Practice, MSL | joshua.gardner@mslgroup.com
SCOTUS Launches New Economy with Legalized Sports BettingMSL
In a 6-3 decision in the case Murphy vs. National Collegiate Athletic Association, SCOTUS ruled that because Congress exceeded its constitutional authority when it passed PAPSA. In essence, Congress tried to prohibit state legislatures from repealing their existing statues that outlawed sports betting. Under a line of Supreme Court precedent known as the anti-commandeering doctrine, federal efforts to coerce states into enforcing federal law are unconstitutional violations of the Tenth Amendment.
To say this is just the beginning would be cliché, but what SCOTUS has wrought with its decision will have lasting consequences that go far beyond sports betting.
Our current consumption patterns are stretched to breaking point. Few would argue the need to fix our systems. It’s how to manage an economically viable and just transition that is making heads ache.
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Is your business goal-ready to move beyond 2020? Explore a new generation of emerging sustainability goals that are unlocking business returns and driving transformational change.
The food market will experience rapid evolution in 2018, according to sector experts at MSL. A broad array of technological innovations will make it easier to acquire and consume foods and beverages tailored to our specific food needs, speeds and philosophies.
These insights emerge from the MSL’s annual analysis of top food trends compiled by its highly specialized food marketing and PR team, appearing as a shareable infographic. In recent years the agency’s forecast has been viewed more than 100,000 times. Past forecasts have spotted the emergence of major marketplace successes, including turmeric, coconut, ugly produce, food waste reduction and coffee as an ingredient.
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Not even a decade after the PR industry turned on its head when social media ushered in the Age of Influence, technology once again is causing brands, companies and organizations to rethink its communication in dramatic ways. This time machines that process data and artificial intelligence, combined with immersive technologies like virtual reality, augmented reality and mixed reality, are creating new opportunities for “augmented influence” as well as giving communicators pause to manage a number of emerging new challenges from Machine Journalism to Artificial Influence.
SDG Signals - SBTribe Research by Salterbaxter MSLMSL
It’s been two years since the launch of the SDGs and the UN’s recent progress report highlights that support is uneven and needs to accelerate. New data sources, including
social media, continue to be vital tools to measure, monitor and report progress.
SDG Signals uncovers new insights about SDG communications online and which areas, people and brands are cutting through. We explore the overall SDG online conversation, providing clear opportunities for differentiation, with initial comparisons from the Technology and Food & Beverage sectors. Future editions will put the spotlight on other specific sectors and issue areas.
A joint initiative conducted by MSL and SPARK Neuro gives PR pros true cause for excitement. What was once only subjective – how much people are engaged with content and their emotional experience with it – can now be directly quantified by reading brain activity and other neurological responses.
For more information about Conversation2Commerce, email Erin.Lanuti@mslgroup.com or visit www.publicisC2C.com.
In PR2020, experts give us their perspective on what’s coming next in terms of tech disruptions, and how they believe this will impact the work we do. We explore influence, data, human science and machines, and our relation to them as communications professionals, business owners, governments, and human beings.
Write to us to start a conversation on how we can help you distill actionable insights and foresights from conversations and communities.
For more information contact Pascal Beucler, SVP & Chief Strategy Officer, Global, MSL (pascal.beucler@mslgroup.com) and Melanie Joe, Consultant – Research & Insights, MSL (melanie.joe@mslgroup.com)
[Salterbaxter Directions] Human Rights - The Time is NowMSL
Is your business up to speed on the risks and opportunities of human rights issues?
Learn from the early adopters of the UN Guiding Principles Reporting Framework and get ahead of the game.
For more information, connect with @salterbaxterMSL or reach out to us on Twitter @msl_group.
News in the Times of Digital - Indian Media TrendsMSL
The way India consumes news is changing in this digital age. 20:20 MSL's media trends infographic assesses Print v/s Online media consumption and how communications professionals can choose the right media mix through a structured approach.
Connect with our insights experts or share your feedback with us on Twitter @2020MSL and @msl_group.
To supplement Qorvis MSLGROUP's Guide to the Trump Administration, we have created a set of appendencies highlighting expected cabinet and staff appointments as of 12/1/2016.
Governing a Divided Nation - Insights about the 2016 U.S. Presidential ElectionMSL
Public affairs and policy experts from Qorvis MSLGROUP have compiled an extensive election coverage and analysis of how the new U.S. President and Congress will move forward after one of the most bitter campaigns in American history.
For more updates, follow @qorvis or reach out to us on Twitter @msl_group.
Each year, Directions takes an in-depth look at an area of sustainability and communications. This time, we’re delving into the quite sizeable gap that still exists between business and society. It’s not the void that interests us so much as the question of how it can be shrunk.
How do we move from just minding the gap to actually mending the gap?
For more information, connect with @salterbaxterMSL or reach out to us on Twitter @msl_group.
Qorvis MSLGROUP has created a comprehensive guide to the Trump Administration. This document provides a first look at the people and players behind the most unlikely presidential campaign in American history.
For each person mentioned here, we have included a bio, a photo, and representative institutions and organizations affiliated with that person, so that the reader may better understand the relationships that influence the people who in turn are influencing President Trump.
For real-time updates, follow @Qorvis or reach out to us on Twitter @msl_group.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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NVBDCP.pptx Nation vector borne disease control programSapna Thakur
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- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
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The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
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2. SPECIAL EDITION EU HEALTHCARE POLICY DEVELOPMENTS
Brussels, 22nd March 2013
In this policy alert we provide an overview of the latest EU policy and regulatory developments in
relation to healthcare.
Although the organisation and delivery of healthcare is the responsibility of each EU Member
State, the role of the EU is to complement and adds value to the national policies by addressing
common challenges and by establishing a level-playing field in terms of market access for the
industry. In its mission, the EU is assisted by ad hoc agencies such as the European Medicine Agency
(EMA) and the European Food and Safety Agency (EFSA). The technical investigation and scientific
opinions provided by these agencies underpin the policy orientations and decisions taken by the EU
institutions, notably the European Commission, the Council and the European Parliament.
The EU priorities in the 2013 health work plan include active and healthy ageing, patients' rights
and safety, and effective ways to make health systems more sustainable. Key regulatory changes
on the table of the EU institutions for the months ahead include a number of revisions, namely:
- the Directive for clinical trials, with parliamentary and Council work expected to last also
in 2014;
- the Directives for medical devices, with a view to reach final agreement in November this
year;
- the Directive for prices of medicines, with negotiations expected to last until mid-2014;
- the Tobacco Products Directive, with the objective of finalising a compromise before the
next European Parliament’s elections in 2014;
- the Directives on occupational health and safety, with a view to reach final agreement at
the end of this year.
New legislative proposals planned in the 2013 working programme and expected in the coming
months include:
- proposals for new Regulations on the production and marketing of Plant Reproductive
Material, Plant Health and national and EU controls, seeking to reduce administrative
burdens by introducing plant passports and quarantine measures;
- a simplified framework on Animal Health, due to replace 40 different Directives, and
legislation on veterinary medicines where pro- and post- marketing authorisation will be
facilitated.
I hope that you will find this overview useful for your work and remain available for any assistance
you may require in relation to policy intelligence and strategy, advocacy, communication and
stakeholders outreach campaigns.
Leonardo Sforza
Managing Director
| Insight Brussels | 1
3. SPECIAL EDITION EU HEALTHCARE POLICY DEVELOPMENTS
EU healthcare agenda for 2013
***
Table of Contents
1. MEPs disagree on clinical trials ....................................................................................................3
2. New rules on medical devices and in vitro diagnostic medical devices to be adopted ..................3
3. Pricing and reimbursement of medicines: new move from the European Parliament ..................4
4. On-going discussions on the revision of the Tobacco Directive ....................................................4
5. Pharmaceuticals: new symbol identifies medicines undergoing additional monitoring ................5
6. European Commission wants to improve labelling of hazardous products ...................................5
7. Cosmetic products: full ban on animal testing enters into force ..................................................6
8. European Commission provides €144 million funding for rare diseases research .........................6
| Insight Brussels | 2
4. SPECIAL EDITION EU HEALTHCARE POLICY DEVELOPMENTS
1. MEPs disagree on clinical trials
The European Commission’s proposal for a new Regulation on clinical trials, which was
presented on 17 July and repeals the current Directive 2001/20/EC, is currently being debated
in the European Parliamentary Environment, Public Health and Food Safety (ENVI) Committee.
The current Directive, which was implemented in 2004 with a view to improving research
standards, protecting patients and notably enhancing the competitiveness of clinical research,
has been criticised by researchers for imposing an overly heavily regulatory framework, thus
increasing costs and red tape without bringing any major benefit to patients. Hence, the new
Regulation aims at breathing new life into clinical research in Europe by simplifying procedures.
The new rules are supposed to make it easier for drug companies and researchers to carry out
cross-border clinical trials by introducing a harmonised EU submission system.
The discussions in the ENVI Committee, however, have unveiled substantial disagreements
among MEPs, particular when it comes to the issue of transparency in clinical trial results. NGOs
have called for total transparency in clinical results, which would bring to light what
laboratories are eager to hide and avoid redundant research. Pharmaceutical companies, by
contrast, argue that they have to protect their commercial data and the patients’ private data.
Rapporteur Glenis Willmott (S&D, UK) spoke of the need to quickly find a compromise solution.
With more than 700 amendments to go over, she has only a month to find compromise
amendments with the other political groups. The vote is scheduled for 24 April and, if the
European Parliament wants to close this dossier by the end of its mandate in June 2014, it would
be well advised not to postpone the vote.
2. New rules on medical devices and in vitro diagnostic medical devices to be
adopted
Following the adoption in June 2012 of a Resolution on defective silicone gel breast implants, the
European Parliament has called for the revision of the current regulatory framework related to
the safety of medical technology. Hence, the European Commission presented in September
2012 two proposals replacing the existing Directives on active implantable medical devices and
on in vitro medical devices. The aim of both proposals is to address inconsistencies in Member
States’ interpretation of the current rules, to increase the protection of public health and safety,
to remove obstacles in the internal market, to improve transparency with regard to information
to patients, and to strengthen the rules on traceability.
The draft Regulations also propose to strengthen the powers and obligations of assessment
bodies, which authorise the placing on the market of devices qualifying for the CE label, through
evaluations before and after market release, regular checks on manufacturers, including
announced factory inspections and sample testing. In addition, the draft reinforces the
supervision powers of these independent assessment bodies by national authorities (Member
States can freely manage these bodies), while introducing controls carried out jointly by national
experts and the European Commission.
| Insight Brussels | 3
5. SPECIAL EDITION EU HEALTHCARE POLICY DEVELOPMENTS
On 21 March 2013, members of the European Parliamentary Environment, Public Health and
Food Safety Committe had their first exchange of views on the European Commission’s proposal,
before the reports drafted by the rapporteurs Dagmar Roth-Behrendt (S&D, Germany) and Peter
Liese (EPP, Germany) will be presented next months. The rapporteurs agreed that the proposal
will improve the safety of patients, but they also stressed the need to reinforce the aspects
related to the information provided to the patient, with particular emphasis on the question of
informed consent. Discussions on these draft Regulations will continue within the European
Parliament and the EU Council with the view to adopt the new provisions in November this year.
3. Pricing and reimbursement of medicines: new move from the
European Parliament
In February, MEPs adopted a report by Bulgarian liberal MEP Antonyia Parvanova on the
medicine prices transparency Directive.
Through its proposal unveiled in March 2012, the European Commission wants to address the
question of medicine prices to further improve the transparency of measures regulating the
prices of medicinal products and reimbursements, dating back from 1989. Key issues include
shorter time limits for pricing and reimbursement, as well as faster introduction of generic
drugs on the market. In this sense, the proposal aims at reducing the deadline to 120 days (60
for the decision on the price and 60 for reimbursement), while MEPs call for 180 days (90 and
90). Concerning generics, while the Commission proposed 30 days (15 and 15),
parliamentarians have opted for 60 days (30 plus 30).
European Commissioner for Industry, Antonio Tajani, has shared with MEPs its willingness to
accept this compromise text, because strong disparities have emerged during the discussions,
both in the European Parliament and in the EU Council, where Member States are concerned by
by the opportunity for the European Commission to intervene in this area and by the changes
that the new law would make to national price-setting systems. Tough negotiations lie ahead.
4. On-going discussions on the revision of the Tobacco Directive
Around three months after the European Commission presented its proposal, debates on the
revision of the 2001 Tobacco Products Directive are accelerating. At the end of March, the topic
had already been discussed four times in the EU Council, with the Irish Presidency planning
another nine meetings, and the European Parliament’s report, prepared by rapporteur Linda
McAvan (S&D, UK), is expected at the end of this month.
During an exchange of views between members of the European Parliamentary Environment,
Public Health and Food Safety (ENVI) Committee on 21 March, McAvan already made clear that
she fully supports the European Commission’s proposal, which introduces new and
strengthened rules on tobacco products, such as large pictorial health warnings. Moreover,
McAvan emphasised she is determined to defend the well-being of European citizens, instead of
flinching before the arguments put forward by the tobacco industry.
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6. SPECIAL EDITION EU HEALTHCARE POLICY DEVELOPMENTS
On the whole, however, positions on the proposal vary widely. Some MEPs, such as Satu Hassi
(Greens, Finland) and Martina Anderson (United Left, UK) are in favour of a more robust text
than that proposed by the European Commission, supporting compulsory neutral packaging and
a ban on all added aromas and flavourings without exceptions. Other MEPs, next to several
Member States and the tobacco industry, draw attention to the proposal’s potential negative
impact on the economy, expressing concerns that the new Directive could damage a multibillion
Euro industry and destroy jobs at a time when the EU has to grapple with the economic crisis.
Proponents of the proposal would like to see it adopted before the parliamentary elections in
2014, which means that the EU institutions are now racing against time.
5. Pharmaceuticals: new symbol identifies medicines undergoing
additional monitoring
Following a Regulation adopted by the European Commission on 7 March, an inverted black
triangle will soon appear on the inside leaflet of certain medicinal products on the EU market.
The purpose of the symbol is to allow patients and healthcare professionals to easily identify
medicinal products that are undergoing additional monitoring. The accompanying text is aimed
at encouraging people to report unexpected adverse reactions through national reporting
systems.
The new symbol will be required to be part of pharmaceutical product labels from September
2013. The medicines that are part of this requirement are the following: all medicinal products
authorised after 1 January 2011 that contain a new active substance; biological medicinal
products, such as vaccines or plasma derived products, authorised after 1 January 2011; and
products for which certain additional information is required post-authorisation, or for which
authorisation is subject to conditions or restrictions on their safe and effective use.
Through the EU pharmacovigilance system, the safety of an authorised medicinal product is
monitored throughout its entire lifespan to ensure that, in case of adverse reactions that present
an unacceptable level of risk under normal conditions of use, it is rapidly withdrawn from the
market. This system underwent a major review leading to the adoption of new legislation in
2010 to strengthen and rationalise the system for pharmaceutical product safety. The new
Regulation is an Implementing Act of this legislation.
6. European Commission wants to improve labelling of hazardous
products
The European Commission aims at better protecting workers from the dangers of exposure to
chemical substances at their workplace. On 26 February, it presented a legislative proposal for a
Directive amending five existing Directives on occupational health and safety to align them with
Regulation (EC) 1272/2008 on the classification, labelling and packaging of chemicals.
The new Directive would require manufacturers and suppliers of chemical substances to
provide harmonised labelling information on hazard classification. Thus, users would be alerted
to the presence of hazardous chemicals, the need to avoid exposure and the associated risks.
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7. SPECIAL EDITION EU HEALTHCARE POLICY DEVELOPMENTS
The proposal has been the subject of two rounds of consultation of employer and trade union
representatives at EU level as well as debates in the Advisory Committee on Safety and Health at
Work (ACSHW). It now goes to the EU Council and the European Parliament for further
elaboration.
7. Cosmetic products: full ban on animal testing enters into force
The European Commission decided that the final deadline of 11 March for phasing out animal
testing for cosmetic products has to be observed by the cosmetics industry if they wish to
market their products in the EU.
Pursuant to Directive 2003/15/EC, animal testing has been prohibited since 2004 for cosmetic
products and since 2009 for cosmetic ingredients (testing ban). Since 2009, this prohibition has
also applied to the marketing of products that have been subject to animal testing (marketing
ban). However, a derogation existed for tests related to complex human health effects, such as
the toxicity of repeated doses. As of 11 March, the marketing ban is total.
In a Communication published on 11 March, the European Commission informed the EU Council
and the European Parliament of its decision and outlines its policy priorities in this area:
ensuring a coherent implementation of the marketing ban and monitoring its impact, continuing
the support for research on alternative testing methods; and making alternative testing methods
an integral part of the EU’s trade agenda and international cooperation.
8. European Commission provides €144 million funding for rare
diseases research
On Rare Disease Day 2013 (28 February), the European Commission announced €144 million of
new funding for 26 research projects on rare diseases in order to help improve the lives of some
of the 30 million Europeans suffering from them. The selected projects, which cover a broad
spectrum of diseases, bring together more than 300 participants from 29 countries in Europe
and beyond. The aim is to pool resources and to work beyond borders to get a better
understanding or rare diseases and to find adequate treatment.
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8. SPECIAL EDITION EU HEALTHCARE POLICY DEVELOPMENTS
For further information please contact:
Leonardo Sforza (leonardo.sforza@mslgroup.com)
Romain Seignovert (romain.seignovert@mslgroup.com)
Klas Landelius (klas.landelius@jklgroup.com)
Andrea Oechsler (andrea.oechsler@mslgroup.com)
MSLGROUP – JKL Group Brussels, Avenue des Gaulois, 18 – B 1040 Bruxelles
Follow us on twitter : @MSL_Brussels
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