Policy Impact - European Union

Q4 2009

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. More.

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. More.

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. More.

Article IV: European Health Forum Gastein 2009 Focused on the Economic and Financial Crisis

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. More.

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. More.

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. More.

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. More.

Public Policy Newsletter - EU Q4 2009 (PDF, 510 KB)

Summer 2009

Article I: CSL Behring Co-Signs EURORDIS Paper to Improve Access to Orphan Drugs in Europe

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). More.

Article II: CSL Behring Participates in German Metaforum: “Innovation in the Health System”

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. More.

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. More.

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. More.

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. More.

Public Policy Newsletter - EU Summer 2009 (PDF, 535 KB)

Spring 2009

Article I: European Parliamentarians Launch “Call for Action” on Rare Plasma Protein Disorders

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. More.

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. More.

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. More.

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. More.

Article V: “European Principles of Hemophilia Care” Tackle Disparities of Care across EU

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. More.

Public Policy Newsletter - EU Spring 2009 (PDF, 428 KB)

Winter 2008/09

Article I: CSL Behring awards three-year educational grant for new European rare diseases policy project

CSL Behring awarded a three-year educational grant to EURORDIS, the European Organisation for Rare Diseases, to fund a European rare diseases policy project. This project is the first European initiative designed to systematically collect patient opinions on rare disease policies. It will build consensus on preferred public health policy scenarios, aligned with the CSL Behring commitment to save lives and improve the quality of life for people with serious and rare diseases. More.

Article II: New initiatives to improve the clinical trial environment in the European Union

The European Clinical Trials Directive is under evaluation to improve the competitiveness of clinical trials research being conducted in the European Union. The current initiatives are designed to measure the impact of the existing EU legislation including direct and indirect consequences. The resulting discussion and interpretation is expected to help improve Europe’s attractiveness and competitiveness for clinical research by proposing pathways for to improve the clinical trials environment in the EU. More.

Article III: CSL Behring established partnership with European Patient Forum – a strong patients’ voice to drive better health in Europe

CSL Behring will be joining the panel of funding partners of the European Patient’s Forum (EPF) in 2009. The EPF is the umbrella organisation of pan-European patient organisations active in the field of European public health and health advocacy. EPF was founded in 2003 and currently represents 37 patient organisations, which are chronic disease-specific patient organisations operating at EU level with national coalitions of patient organisations. More.

Article IV: European Parliament Workshop on "Improving care for rare plasma protein deficiency disorders" – Launch of European "Call for Action"

On 2 December, an issue-focused workshop was held at the European Parliament to discuss the European Commission’s proposal for a Council Recommendation in the field of Rare Diseases. The workshop concentrated on plasma-protein related disorders such as haemophilia and primary immunodeficiencies and the EU’s role in helping affected patients. More.

Article V: IFBDO publishes debatable statement on Blood Donation Policy

The International Federation of Blood Donor Organisations (IFBDO) – or FIODS in French – recently published their "proposals for a better blood policy in the European Union". This document entitled "Self sufficiency in safe blood in Europe" re-emphasizes the IFBDO’s previous statements that Europe should achieve self-sufficiency for blood AND plasma from voluntary unpaid blood donations. Once again the statement contains false and outrageous statements against the plasma-protein industry and the use of compensated plasma donations. More.

Article VI: EU research project application intends to develop models to include patient satisfaction in HTA

Within the current call for projects in the scope of the EU Framework Programme on Health (FP 7), one application will be made under the section Healthcare Outcomes and Cost Benefits (as a ‘Collaborative Project’ – small-to-medium scale research project). The focus of this project will be on the development of innovative therapies for severe, chronic diseases and the challenges these create for national health care systems operating within a constrained budget. More.

Public Policy Newsletter - EU Winter 2008 (PDF, 342 KB)

Fall 2008

Article I: CSL Behring Joins EuropaBio as Corporate Member

CSL Behring recently applied for and was granted corporate membership in EuropaBio, the political voice of the biotechnology industry in Europe. Through this membership, CSL Behring will strengthen our cooperation with trade associations engaged in the stakeholder dialogue within the external policy environment. CSL Behring Public Affairs Europe contributes to EuropaBio's Healthcare Council. More

Article II: Health Equality Europe Guides Health Technology Assessment

A new guide titled "Understanding Health Technology Assessment (HTA)" has been issued by Health Equality Europe (see sidebar). The guide describes how patients and the public can become involved in decisions about what types of healthcare should be made available. It can also be used to help raise awareness of patient needs. The guide is written as a toolkit for patient organizations who want to represent the views of patients, but who are struggling to understand what HTA is and how they can best contribute. It outlines typical HTA processes and provides detailed examples of how to contribute to questions about the burden of illness, the effectiveness of the healthcare technology and the impact on caregivers. It explains how to collect information about patients' experiences and how to present written information to ensure that messages are clear. More

Article III: EU Parliamentarian Challenges the European Commission on Blood and Plasma

Thomas Ulmer, a German member of European Parliament, recently submitted a written parliamentary question (PQ) on the differences between blood and plasma donation systems in Europe. Using Germany as an example, this PQ proposes that compensating plasma donors results in an increased supply of plasma. Furthermore, EU Member States that compensate plasma donors account for a significant proportion of the European supply of plasma. Therefore, the PQ underscores the need to differentiate plasma and blood donations in upcoming reports from the Commission. More

Article VI: EU Tables Weakened Cross- Border Healthcare Directive

The former Health Services Directive has now been launched as an instrument within a Social Package focusing on access, opportunities and solidarity, entitled "Patients Rights in Cross-Border Healthcare." The related EU Commission proposal strives to make it easier for citizens to seek care abroad. However, its effectiveness could be limited after new clauses are introduced. These clauses, if introduced, would allow member states to require patients to get prior authorization for foreign hospital care and pay upfront themselves. Overall, the directive is set to clarify the right of patients to seek healthcare in another EU country with reimbursement being provided by their national system. More

Article V: CSL Behring Supports Workshop on Partnering for Rare Disease Therapy Development

The 9th EPPOSI* Workshop on Partnering for Rare Disease Therapy Development entitled "Sharing strategies and tools for access to diagnosis and treatment" will be held in the French National Assembly on October 16 and 17, 2008 as an official event of the French Presidency of the European Union. CSL Behring is partnering with EPPOSI to organize the event. Also, CSL Behring will join one of the workshop's panel discussions focusing on improving early diagnosis and access to care. More

Public Policy Newsletter - EU Fall 2008 (PDF, 278 KB)

Spring 2008

Article I: CSL Behring Strengthens Partnership with European Rare Diseases Organisation

CSL Behring has strengthened its partnership with the European Organisation for Rare Diseases, EURORDIS – a patient-driven alliance of patient organisations and individuals active in the field of rare diseases. Recently, CSL Behring joined the Eurordis Round Table of Companies, established as a long-term educational relationship between Eurordis and manufacturers of orphan drugs or providers of treatments and health services for people living with rare diseases. Eurordis’ mission is to build a strong pan-European community of patient organisations for people living with rare diseases, to be their voice at the European policy level, and – directly or indirectly – to fight against the impact of rare diseaseson their lives. More

Article II: CSL Behring Attends European Patient Forum’s Spring Conference on Health Literacy

As part of increased advocacy activities and publicprivate partnerships, CSL Behring established contacts to the European Patient Forum (EPF) and participated in the organisation’s annual spring conference. The conference focused on health literacy. Given its inclusion in the EU Health Strategy, this is an important topic for representatives from patient organisations across the EU and other healthcare stakeholders. More

Article III: Plasma Companies Respond to EU Commission Consultation on Patient Information

The EU Commission currently collects best practices regarding how physicians should communicate with patients about medicinal products. This procedure follows-up on a legal proposal (EU Communication and staff working document) adopted in December 2007 and encompasses the perspectives of a wide range of stakeholders. More

Article IV: PPTA Position Paper

The Plasma Protein Therapeutics Association (PPTA)1 welcomes the European Commission’s Public Consultation on a Legal Proposal for Information to Patients and is pleased to submit here below key recommendations and ideas on behalf of the plasma protein industry. More

Article V: EU Directive on Cross-Border Healthcare Continuously Delayed

The EU draft Directive on Cross-Border Healthcare, which had been scheduled to be launched by the Commission in December 2007, was unfortunately delayed due to disagreement in the political institutions. This directive protects the basic rights of patients who travel to other EU Member States in order to receive medical treatment. More

Article VI: New Health Commissioner Appointed

Mrs. Androula Vassiliou has taken over as European Union (EU) Health Commissioner following the resignation of Markos Kyprianou. Mrs. Vassiliou, a lawyer, was a Member of the House of Representatives of Cyprus for two terms until 2006, and Vice-President of the European Liberal Democrats and Reform Party from 2001 to 2006. She also chairs the board of trustees of the Cyprus Oncology Centre. More

Article VII: Rare Diseases Subject to Public Hearing in the European Parliament

The European Organisation for Rare Diseases (EURORDIS) organized a Public Hearing on Rare Diseases co-hosted by European Parliamentarians Frédérique Ries and Jules Maaten, to celebrate Rare Disease Day on 29 February. The hearing emphasised the need for entres of Expertise and European Reference Networks to enhance information flow and improve the organisational structure of patient-centred care. More

Public Policy Newsletter - EU Spring 2008 (PDF, 256 KB).

Winter 2007/08

Article I: Voluntary Compensated Donations are Consistent with EU Blood Directive

Voluntary compensated plasma donations remain an important public policy issue. The European Commission recently affirmed its support for voluntary compensated plasma donations. However, this policy issue continues to be questioned by some Members of the European Parliament (MEP). As a result, in conversations with stakeholders such as the Directorate General for Health and Consumer Affairs (DG Sanco), CSL Behring Public Affairs Europe stresses the need for compensated plasma donations in order to ensure future access to plasma protein therapies for patients. More

Article II: 2007 European Conference on Rare Diseases Focuses on Patients’ Needs

“Patients: the heart of rare disease policy development” was the theme of this year’s European Conference on Rare Diseases (ECRD), which took place in Lisbon, Portugal on 27 and 28 November 2007. This biennial conference was organised by EURORDIS and its partners, under the patronage of the Portuguese Ministry of Health, operating within the official agenda of the Portuguese EU Council Presidency, and supported by the European Commission. More

Article III: European Commission Issues Public Consultation on Rare Diseases

High-quality diagnosis, treatment and information for people suffering from rare diseases are priority issues for the European Commission. In order to gather information and expertise on issues facing rare disease communities, the European Commission recently issued a consultation document entitled “Rare Diseases: Europe’s challenges.” This document outlines 14 key questions about rare diseases. Interested parties are invited to comment on and respond to these questions and to explore other relevant issues, if necessary. More

Article IV: Plasma Companies in Europe Adopt New Charter

Member companies of the Plasma Protein Therapeutics Association (PPTA) recently developed a charter for cooperation with external organizations, mainly patient and physician organizations. Increasingly, such charters are being used as policy documents by trade associations to optimize transparency and formalize their relations with stakeholder organizations. The PPTA charter was established in conjunction with the Plasma Protein Users Group and approved by the PPTA’s European Board of Directors in November 2007. Thus, from this point forward, all member companies are committed to adhering to the defined policy framework. More

Public Policy Newsletter - EU Winter 2007 (PDF, 148 KB)