IPCAA NEWSLETTER

Pharmaceutical and Medical Technology Companies Move Closer

In order to demonstrate that compliance issues and regulatory topics are not simply a preserve of the pharmaceutical industry, we have reproduced here information recently released by a leading association of medical equipment and device manufacturers.

Eucomed Expands Compliance Leadership with New “Code of Ethics: Procedural Framework”

Eucomed, the European medical technology association, announced recently that its General Assembly has unanimously approved a new “Code of Ethics: Procedural Framework” to ensure compliancewith its recently updated Code of Ethics.

Eucomed's new Procedural Framework provides an effective and efficient process to further align the medical technology industry on compliant practices and resolutions. The new Procedural Framework, which is based on Eucomed’s Code of Ethics, is an extrajudicial mechanism based on principles of autonomy, proportionality, speed, due process, fairness and transparency. It provides consistent principles and enforcement structures for Europe, building on the existing processes at national level.

A Compliance Panel will ensure consistent interpretation of the Eucomed rules, which are the standard across Europe for the industry. Non-member companies and organisations also have an opportunity to adopt and abide by the Eucomed Code’s principles.

“This new enforcement mechanism reflects the medical technology industry’s ongoing commitment to transparency, legitimacy and high ethical standards,” said Guy J. Lebeau, M.D., Chairman of the Eucomed Board. “Our industry’s primary focus is to improve patients' lives and we want to ensure that collaboration between physicians and the industry’s scientists and engineers is critical for the continued development of health technology innovations.”

Following adoption by the General Assembly, Eucomed will initiate the organisational structures and procedures necessary for this mechanism to operate.

“Nothing is more important for our industry than to maintain public trust and safeguard integrity,” said John Wilkinson, CEO of Eucomed. “The action by Eucomed's General Assembly sends a strong signal that we take seriously our responsibility for legitimate and ethical business practices.”

The Procedural Framework is based on the Eucomed “Code of Ethics” and Q&A which includes guidelines on the Interaction with health care professionals throughout Europe.

Going online in 2010 on eucomed.org is a publicly available e-learning course on its Code of Ethics as well as a self-certification programme which will offer member and non-member companies an opportunity to certify their compliance with the Association’s code.

“It is interesting to note developments in compliance and self-regulation outside the pharma industry.” says Anna Frick, President of IPCAA, “Many people believe that these situations are exclusive to us, and it is clear that throughout the whole healthcare industry, there is constant activity to ensure interaction between suppliers and healthcare professionals is carried out in an appropriate way. I look forward to future cooperation and exchanges of views among all branches of the healthcare research and manufacturing industry”.

Eucomed is the Voice of the medical technology industry in Europe. Eucomed represents directly and indirectly 4500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. As opposed to the pharmaceutical industry, small and medium sized companies make up more than 80% of this sector by value. The European medical technology industry invests some €5.8 billion in R&D and employs near to 530,000 highly skilled workers. The mission of Eucomed is to improve patient and clinician access to modern, innovative and reliable medical technology.

Constructive Public Affairs

Eucomed actively engages with EU institutions and regulatory bodies to encourage a positive public policy environment which is supportive of continuous innovation in medical technology, allowing the sector to optimise its value to patients and society.

Enhancing Dialogue

Eucomed's stakeholder relations are built upon partnerships with patient groups and medical associations and upon proactive high profile European events, such as the MedTech Forum - all of which is supported by a range of communication tools and ongoing engagement with media.

Providing Market Insight

Eucomed's initiatives on health economics provide insight into the value of the medical devices sector by delivering accurate data to all stakeholders on the impact of funding and reimbursement systems and emerging trends such as the growth of homecare and the industry.

Reinforcing Industry Values

Eucomed has developed a leading Code of Business Practice, which is implemented by members and is regularly reviewed and updated.

Joining the International Debate

Eucomed represents the European medical technology sector in international forums, such as the Global Harmonization Task Force (GHTF), and liaises with representative bodies from the US, Japan, China, India, and Brazil.

A large and increasing number of decisions that impact the Medical Technology Industry within Europe and beyond its borders are made at EU level or influenced by the EU. Eucomed is uniquely placed to influence EU policy-making processes and thinking to the benefit of our Members, thanks to Eucomed’s extensive knowledge of and partnership with key European institutions and decision-makers.

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