Policy Impact - European Union
CSL Behring is committed to informing decision-makers and impacting public policies that affect patient access to care.
The company has an active public affairs group worldwide led by Dennis Jackman, Senior Vice President, Public Affairs
and Ruediger Gatermann, Director, Public Affairs Europe. Ruediger has an extensive public policy background and works
closely with affected stakeholders and political thought leaders to affect change in European policy.
Topics covered in this issue include rare disorders without borders, adopting and implementing national plans for rare diseases, patient registries are becoming a priority, and a view of the current environment for evaluating the economics of innovative therapies for rare diseases.
Article I: EU Commission Launches Study on Blood,
Blood Components and Plasma Derivatives
The European Commission’s Health and Consumers
Directorate General (DG SANCO, Substances of Human
Origins group), has launched a study to examine the
markets for blood and blood components including
Article II: EPPOSI Program Develops
Societal Benefit Approach
EPPOSI, the European Platform for Patient
Organizations, Science and Industry, held a HTA
Expert Meeting this summer as part of the
platform’s Advanced Innovation Program in
Health Technology Assessment (AIP-HTA).
Article III: EU Commission Launches
Public Consultation on
European HTA Network
The European Commission, DG Health and
Consumers, has launched a public consultation on
the modalities of stakeholder involvement in the
voluntary Health Technology Assessment network
to be established under the Directive on Patients’
Rights in Cross-Border Healthcare (2011/24/EU).
Article IV: European Conference on
Rare Diseases Drives EU
Public Health Agenda
The 2012 European Conference on Rare Diseases
and Orphan Products in Brussels was held in May.
Article V: Industry Recommendations
for National Rare Disease
Plans Agreed Upon
The EBE-EuropaBio Joint Task Force on Rare
Diseases and Orphan Medicinal Products (JTF)
agreed to revised industry key recommendations
on national plans for use in discussions and
policy outreach at the EU Member State Level.
CSL Behring Public Affairs contributed to the
Article VI: Collaborative Joint Industry
Project Investigates External
Stakeholder Engagement for
The EBE-EuropaBio Joint Task Force on Rare
Diseases and Orphan Medicinal Products (JTF)
decided to conduct a perception survey of how
key policymakers and public policy stakeholders
perceive key issues related to orphan medicinal
products and treatment of rare diseases.
Article VII: EHC Roundtables Target
Economics and Health
Outcomes in Hemophilia
and Clinical Trials
During periods of economic crisis and with
European Union health budgets under increasing
constraints it is more important than ever that
economic and health technology appraisals take
into consideration patients’ views.
Article VIII: CSL Behring Received Award
from European Patient
Organization for Rare Diseases
CSL Behring was the recipient of a 2012 EURORDIS
Award earlier this year for its pioneering work in
developing and manufacturing therapies used to
treat rare and serious medical conditions.
Public Policy Newsletter - EU Fall 2012 (PDF, 772 KB)
Article I: Healthcare Industry Issues Joint Paper on Industry Involvement in HTA
Several healthcare trade associations including EuropaBio, the European association for bio-industries, have issued a paper on "The Value of Industry Involvement in Health Technology Assessment (HTA)".
Article II: Expert Group Launches PID Recommendations in German Parliament
The German Recommendations for Primary Immunodeficiency (PID) were developed by a panel of experts composed of patients, leading physicians and policy-makers led by two Members of Parliament, Mrs. Aschenberg-Dugnus, Member of the Health Committee and Mrs. Bracht-Bendt, Chair of the Children’s Committee.
Article III: EPPOSI Launches "Advanced Innovation Programs" for European Health Policy Development
The European Platform for Patient Organizations, Science and Industry (EPPOSI) has launched four Advanced Innovation Programs on Chronic Conditions Management, Health Technology Assessment (HTA), Innovation in Healthcare and Rare Diseases.
Article IV: EURORDIS Round Table of Companies (ERTC) analyzes "Compassionate Access to Rare Disease Therapies"
The European Rare Diseases Patient Organization (EURORDIS) held its 15th ERTC workshop in Paris in November on "Compassionate Access to Rare Disease Therapies."
Public Policy Newsletter - EU Q3 2012 (PDF, 766KB)
Article I: Key Issues Dialogue on Rare Diseases Published
CSL Behring has published a special edition in its Key Issues Dialogue series – "Making Rare Diseases a Global Public Health Priority" – in conjunction with Rare Disease Day 2011.
Article II: Europe Rare Disease Day Event a Resounding Success
CSL Behring joined the European and US patient organizations EURORDIS and NORD in supporting Rare Disease Day 2011. The annual campaign raises international awareness of rare disease and the impact it has on patients' lives. Rare Disease Day 2011 also reinforced the importance of rare disease as a public health priority.
Article III: European Parliament Paves Way for Cross-Border Healthcare
Members of the European Parliament recently approved the Directive on patients' rights in cross-border healthcare which allows EU citizens to be reimbursed for healthcare services they receive in another Member State, as long as the type of treatment and costs would have normally been covered in their own country.
Article IV: Recommendations for Better Care for Rare Disease Patients
Eight recommendations to address the shortfalls in effective diagnosis, treatment and care for rare disease patients across the EU were agreed to at the 11th Workshop on Partnering for Rare Disease Therapy Development, held in Prague in late 2010.
Article V: European Primary Immunodeficiency (PID) Recommendations Published
A European panel of experts composed of patients, leading physicians and policy-makers led by Member of European Parliament (MEP) from Germany Jorgo Chatzimarkakis prepared a set of high level recommendations for European Member States on how to tackle Primary Immunodeficiency (PID).
Public Policy Newsletter - EU Q2 2011 (PDF, 625 KB)
Article I: European Patients Partnering in Clinical Research
Patient organizations, researchers and companies from across Europe met in Brussels
on 11 June 2009 with a simple yet ambitious target: to start a dialogue on how patients
can become partners in clinical trials.
Article II: EUROPLAN Develops Recommendations for Rare Disease National Plans
Following a meeting in Amsterdam on 17 September EUROPLAN issued a draft of the
recommendations for the National Plans for rare diseases. The European Project for
Rare Diseases National Plans Development (EUROPLAN) is a three-year project of the
Programme of Community action in the field of Public Health (2003 – 2008), which
began in April 2008.
Article III: European Hemophilia Consortium Calls for Patient Empowerment and Better
Health Literacy Skills
Participants in the 7th European Hemophilia Consortium (EHC) Round Table on 8 October
called for timely, coordinated and quality information for treatments and drugs
available for patients. It was also agreed that patients must be proactively consulted
and empowered, so as to bring added value to the decision making process and improve
the current paradigm in delivering information to patients.
Article IV: European Health Forum Gastein 2009 Focused on the Economic and Financial
The European Health Forum Gastein (EHFG) is the most important health policy event
in the European Union. Leading experts from business and industry, science and academia,
patient organizations/NGOs as well as numerous prominent decision makers in health
policy, convene annually to present new ideas.
Article V: European Patient Forum Strengthens EU Health Advocacy
On 18-19 September 2009, the European Patient Forum (EPF) and the VALUE+ Consortium
held a seminar for 50 patient leaders of European patient organizations. The aim
was to build knowledge about working at the EU level and effectively influencing
the EU health policy debate through regional and national initiatives.
Article VI: U.S. and European Rare Disease Organizations Sign Strategic Alliance
On behalf of rare disease patients and their families the leading advocacy groups
for Americans and Europeans with rare diseases—the National Organization for Rare
Disorders (NORD) and the European Organization for Rare Diseases (EURORDIS)—have
signed a Memorandum of Understanding to join forces on several key strategic initiatives.
The intent is to increase global awareness, promote research and the development
of new treatments, and provide advocacy for more compassionate public policies.
Article VII: Health Priorities of the Spanish EU Presidency
The health priorities of the Spanish EU Presidency (from January until June 2010)
have not yet been published. However, there will likely be significant emphasis
on Influenza H1N1, ageing and e-health. The European Patient Forum, with whom CSL
Behring has an ongoing partnership recently proposed a number of issues for inclusion
in the Spanish Presidency's priority list.
Public Policy Newsletter - EU Q4 2009 (PDF, 510 KB)
Article I: CSL Behring Co-Signs EURORDIS Paper to Improve Access to Orphan Drugs
EURORDIS, the European patient organization for rare diseases, has issued recommendations
on improved access to orphan drugs in Europe. As a member of the EURORDIS Round
Table of Companies, CSL Behring endorses the recommendations that propose the establishment
of a Working Party at the European Medicines Agency (EMEA) dedicated to assessing
the Clinical Added Value of Orphan Drugs (CAVOD).
Article II: CSL Behring Participates in German Metaforum: “Innovation in the Health
CSL Behring was the only company from the plasma sector and one of few pharmaceutical
companies invited to contribute to the MetaForum “Innovation in the Health System.”
The MetaForum was launched by the German Fraunhofer Institute for Systems and Innovation
Research to lay the foundation for improved assessment processes. All relevant stakeholders
met to develop a common understanding of how to assess innovations in the health
system in order to provide treatments of the highest value to patients.
Article III: EU Council adopts Recommendation on Rare Diseases
On 9 June 2009, the Council of the European Union adopted the proposed Council Recommendation
on European Action in the Field of Rare Diseases. This recommendation calls upon
Member States to implement national plans for rare diseases before the end of 2013.
For rare disease patients in Europe, the Council Recommendation represents an important
milestone that calls for concerted action at the EU and national levels.
Article IV: EU Council adopts Recommendation on Patient Safety
The EU Council adopted its Recommendation on Patient Safety and Healthcare Associated
Infections (HAI) on 9 June 2009. The Recommendation addresses a set of general patient
safety issues, including empowering and informing citizens and patients through
the dissemination of information on patient safety standards. Thus, the Recommendation
provides a valuable framework for communicating the high safety standards maintained
in the plasma sector.
Article V: Swedish Presidency of the EU: Digital Guide and Priorities for Health
On 1 July, Sweden assumed its term as EU Council Presidency, replacing the Czech
Republic. A digital guide, Inside the Swedish Presidency of the EU, outlines the
politics, mechanics and substance of the EU policy for the next six months.
Public Policy Newsletter - EU Summer 2009 (PDF, 535 KB)
Article I: European Parliamentarians Launch “Call for Action” on Rare Plasma Protein
A new “Call for Action” highlights the EU's role in helping patients with plasma
protein disorders. Two members of the European Parliament, Slovakian MEP Mikolasik
and German MEP Chatzimarkakis, have officially launched the document, which will
be circulated in the European Parliament to give members the opportunity to sign
it and show their support for patients with rare and serious diseases and to raise
awareness about the challenges they face.
Article II: CSL Behring Supports Annual Rare Disease Day
CSL Behring recently joined the supporters of Rare Disease Day by signing a letter
of agreement with the European Organization for Rare Diseases (EURORDIS). The purpose
of Rare Disease Day 2009 is to raise awareness among policy makers and the public
about rare diseases and their impact on patients' lives. This year the main emphasis
is on rare diseases as a public health priority and the need for Centers of Expertise.
Article III: Study on European Patient Access to Rare Diseases Therapies Published
“The Voice of 12,000 Patients,” a new book published by EURORDIS, was presented
on Rare Disease Day 2009. The book presents an analysis of data collected through
two surveys (EurordisCare2 and EurordisCare3) about the experience and expectations
of 12,000 patients.
Article IV: CSL Behring Joins Round Tables of Stakeholders for Hemophilia Care
CSL Behring sponsors a series of round tables of stakeholders organized by the European
Hemophilia Consortium (EHC) to address concerns and share progress and success stories.
At these annual round tables, clinicians, patient representatives, European Union
officials and the pharmaceutical industry target issues including health economics,
patient information and patient mobility.
Article V: “European Principles of Hemophilia Care” Tackle Disparities of Care across
On 27 January 2009, the European Parliament launched the “European Principles of
Hemophilia Care.” These ten principles outline the collective approach of clinicians,
nurses and patients to raise awareness and tackle disparities of care across Europe.
The principles include a call for the availability of prophylaxis treatment, hemophilia
patient registries, home treatment, education and research.
Public Policy Newsletter - EU Spring 2009 (PDF, 428 KB)