Medical Technology Collaboration: Getting the Balance Right

As the legitimacy of interactions between various health care stakeholders becomes a focus of government agencies, the general public, and the political world, the medical technology industry has committed itself to ensuring that its vital cooperation with health care professionals is both transparent and ethical. Eucomed's recently updated Code of Business Practice sets a new Europewide standard for ethical behavior in industry-professional interactions (see Eucomed Guidelines in the Ophthalmic Industry). Its successful application will depend as much upon support and understanding from health care professionals as from medical technology companies. This article provides a general overview of how Eucomed's code pertains to the ophthalmic industry.

Physicians are the key drivers of innovation in the medical technology sector. Because health care professionals (HCPs) comprise the primary users of new technology, they play an instrumental role in the effective and safe use and diffusion of new technologies. As a result of the long-standing and proud tradition of collaboration between HCPs and the medical technology sector, many groundbreaking technologies have emerged over the years to dramatically enhance efficacy of care and patient quality of life.

Now more than ever, however, it is essential to ensure that such productive relationships are founded upon the highest ethical and professional standards. This is particularly true in the current political climate where all professionals—auditors, engineers, and lawyers alike—are under increasing pressure to demonstrate the existence and enforcement of rigorous ethical guidelines.

MEDICAL TECHNOLOGY REQUIRES COLLABORATION
HCPs and the medical technology sector have a symbiotic relationship, particularly in the areas of (1) research and development and (2) training and education. Adherence to ethical standards is an overarching need in both.

Partnerships between medical technology companies and HCPs advance medical science through the research and development of new technologies and the improvement of existing products and services. As with other medical disciplines, ophthalmic HCPs provide vital input, which enhances the quality and efficacy of care for patients worldwide. Medical technology companies also support education and enhancement of professional skills that contribute to patient safety. To ensure the safe and effective use of new medical technology, companies often offer appropriate instruction, education, training, service, and technical support.

All stakeholders must see and ensure that the HCPs' obligation to make independent treatment decisions is respected. Eucomed members recognize this and support high ethical standards and compliance with applicable laws. Going forward, maintaining public support for such interactions between clinicians and industry will depend upon the ability to demonstrate the legitimacy of the relationship, especially since public funds are often involved.

As technologies, practices, and standards increasingly evolve beyond strict national and cultural boundaries, and as health care systems and regulations evolve in European countries and other continents, there is also a growing need to establish a consistent pan-European framework for collaboration. Interestingly, the systems of collaboration are consistently built on are the same principles around the world.

RISE OF ETHICAL POLICY CONCERNS
We have seen a rapid rise in the number of ethical and anticorruption initiatives globally in the past few years. This trend has included policymakers setting rules that affect not only companies but also include corporate executives and physicians.

For the medical technology sector in particular, a multiplicity of new rules and stakeholders has emerged. International bodies such as the Organization for Economic Cooperation and Development (OECD) and numerous national organizations are contributing to the debate on ethical norms. In Europe, Eucomed is promoting a culture of integrity and ethical business practices across the health care sector. The objective is to establish a harmonized approach to eliminate unethical behavior, particularly from the side of industry. It is undoubtedly in the interest of both HCPs and industry to make sure that ethical behavior is embedded into routine professional collaborations.

UPDATED CODE OF BUSINESS PRACTICE
Eucomed's Code of Business Practice illustrates how best to implement the rules of engagement between stakeholders. The recent revision of the code introduced stronger wording, identified the four key principles of interaction, and developed guidance documents to provide greater clarity and transparency. It provides a clear framework for assessing the appropriateness of the collaboration between the medical industry and HCPs. The code is available online at www.eucomed.be/ethics.aspx.

The code provides a new dimension to the ethical conduct between HCPs and industry. More important, with the adoption of a dispute resolution framework, it aims to provide the oversight, credibility, and transparency expected from today's policymakers and health care stakeholders.

The code addresses specific issues such as: (1) what constitutes a suitable location and venue for meetings, trainings, and congresses; (2) what are appropriate remuneration terms for consultancy agreements; and (3) what can be considered as acceptable gifts and hospitality. The code emphasizes that regional variations can apply when assessing what is the appropriate standard, (eg, in the context of a gift or hospitality event). For any instance covered by the code, stakeholders must comply with any applicable local laws, regulations, and professional codes of conduct in place.

THE PRINCIPLES OF ETHICAL COLLABORATION
The Eucomed Code of Business Practice is founded upon four mutually supportive principles: separation, transparency, equivalence, and documentation, which should underpin all interactions between HCPs and the medical technology industry.

Separation. This principle recognizes and supports the need of each HCP to make independent decisions regarding treatment. It safeguards against conflicts of interest by clearly differentiating commercial interactions relating to sales and purchasing of medical technologies from the giving of care. It also defines what can constitute conflicts of interest within other interactions, including research, product education, and other types of training.

Transparency. This principle outlines the steps necessary to ensure that interactions between stakeholders are consistent with European and local law and provides guidance on how all parties can demonstrate that collaborations are conducted ethically. For example, when inviting a HCP affiliated with a local hospital to an industry-sponsored conference, the code provides that the sponsoring company should always notify the hospital administration or the HCP's supervisor (or a locally designated body), fully disclosing the purpose and scope of the engagement.

Equivalence. This principle relates to the terms of remuneration for any service that an HCP might perform. It provides guidance that stakeholders can use to ensure that a fair-market value is paid for such services (eg, the HCP's fee for presenting at a symposium or congress or the general fee included in a consultancy research agreement).

Documentation. Keeping a proper record of any agreement between two professional parties in any modern context is essential to avoid misunderstanding or dispute. This code principle extends that commonly used concept to HCP-industry collaboration and requires that proper supporting documents, which can substantiate the integrity of the collaboration, are used and will be made available if necessary.

If applied correctly, these four principles ensure that the necessary relationships between different stakeholder groups within the medical sector are ethical, legal, and mutually respectful. Eucomed and its members and constituents strongly believe that it is in the interest of all medical sector stakeholders, including industry and its HCP partners, to embrace the code and its underlying principles.

Aline Lautenberg is a Legal Counsel for Eucomed. She may be reached at e-mail: Aline.Lautenberg@eucomed.be.

John Wilkinson is the Chief Executive of Eucomed. He may be reached at e-mail: John.Wilkinson@eucomed.be.