Dutch Health Group

• Netherlands

• Health and life sciences

01-12-2008

Eversheds Faasen, with offices in Amsterdam and Rotterdam, is part of Eversheds International. We represent private and listed companies, public sector enterprises, financial institutions and governments. We are a quality boutique firm amongst the large law firms and act on behalf of our clients in a wide variety of advisory, transactional and litigation work, both on corporate and employment law issues. In addition to our public and private corporate and M&A capabilities, we provide clients with expert advice on private equity, corporate housekeeping, restructuring, competition/antitrust issues and other regulatory obligations.

Introduction Dutch Health Group

Eversheds Faasen's Health Group consists of the following contact persons:

• Rob Faasen;
• Claudine Maeijer;
• Michel Chatelin.

Expertise and Experience of the Dutch Health Group

The health sector is rapidly changing. This is particularly true since the introduction of the new law on health care market regulation. There are numerous developments in technological innovation and in the governmental policy in healthcare provisions. The health services industry is becoming liberalized.

Our health services practice draws on the expertise and experience of the legal specialists in amongst others corporate law, mergers & acquisitions, competition law, labour law, finance and notarial services.

The Health Group lawyers of Eversheds Faasen have specialised expertise in the field of amongst others:

• Mergers and acquisitions, venture capital and private equity investments and partnerships;
• Notification of mergers and joint ventures to the Dutch competition authority;
• Corporate governance;
• Restructuring;
• Professional liability and insurance;
• Litigation and dispute management;
• Commercial contracts;
• Regulatory issues (i.e. private clinics and privatization);
• The set up of specific (foreign) projects and private care houses for elderly or disabled people;
• European law (competition law, free movement of goods);
• Procurement; and
• Employment law (relationship with medical staff and remuneration).

We look forward to further teaming up together with Eversheds International to discuss business opportunities and market developments.

We feel it might be interesting for you to be provided from time to time with a short Newsletter in order to update you on specific Dutch (legal) issues which might affect the healthcare sector in the Netherlands.

Risks of medical technology and closing of intensive care departments

As a start this Newsletter addresses some key issues of the summary with regard to the report "Risks of medical technology underestimated", The Hague, October 2008, as drafted by the Netherlands Health Care Inspectorate (IGZ).

The IGZ protects and promotes health and healthcare by ensuring that care providers, care institutions and companies comply with laws and regulations. The IGZ acts in the public interest and concentrates mostly on problems that members of the public are unable to assess or influence themselves. The mission focuses on patient safety, effective care and care that is patient orientated.

Quote:

"Developments in brief

Medical technology is undergoing major developments, with new techniques and devices being introduced in quick succession. Marked improvements in diagnostics and treatment have become available for patients.

Objective: to ensure the safe application of medical technology

Without discouraging innovation, the IGZ considers it important that patient safety is maintained at all times. The objective of the Report is to provide insight into some of the risks associated with new medical technology and to propose ways in which to ensure the highest possible level of patient safety. The IGZ concludes that many health care institutions are not adequately aware of the risks associated with medical technology, and that too little is being done to ensure patient safety.

Recommendations and measures

The IGZ has provided certain recommendations and measures which must be implemented by amongst others:

Management Board members of care institutions

• A care institution's Management Board is directly responsible for ensuring that medical technology is applied only by care providers who are demonstrably competent. The Board must regularly ascertain that staff is competent.
• The Management Board must enter into agreements with the medical staff with regard to the manner in which individual specialists are to ascertain that technology and equipment can be used safely at all times.

Recommendation to certification bodies

• Certification bodies should include requirements for medical technology and equipment in their certification schemes.

Recommendation to health care insurers

• When contracting a provider, health care insurers are directly responsible for ensuring the quality of the care to be provided. They must approve (and reimburse the costs of) only those technologies which are of demonstrable high quality.
• Health care insurers should also impose requirements in terms of the competence of health care providers, particularly in connection with the reimbursement of new therapies.

Recommendation to scientific organizations and professional federations

• Those who wish to pioneer the use of new and innovative technologies must advise the scientific organizations and professional federations with regard to the procedures which may not be conducted without a test of competence. These organizations are jointly responsible for developing field norms, competency requirements and training opportunities.
• These measures should be incorporated into the inspection cycles and existing quality frameworks in the various sectors within the next two years.

Measures to be implemented by equipment manufacturers/suppliers

• For medical devices used in hospital care, chronic care and home care, manufacturers and/or suppliers should actively collect and collate experiences of users in all sectors, further to the statutory post-marketing surveillance requirements.
• Manufacturers and/or suppliers must provide all documentation, including the user and maintenance manuals, in the Dutch language.
• User manuals should be written in a style which is appropriate to the knowledge and experience of the target readership, with due regard for the circumstances in which the technology or equipment is to be used.â€

On 12 December 2008 the IGZ stated that four small hospitals must close their intensive care departments with immediate effect because they do not meet essential standards. A further 35 hospitals have two months to improve the quality of their ICs or they could be ordered to shut down as well. The Dutch hospital association disputes the report's findings, which it calls "inaccurate".

Assignments 2008

Please find below a short selection of projects we have been involved in 2008:

• Contractual, litigation and corporate advice with respect to a private health project for elderly people in Spain, Residencia La Cigüeña, to one of the largest Dutch Home Care Organizations;
• Contractual and corporate advice to several private organizations active in setting up private care houses for disabled elderly people;
• Contractual, corporate and finance advice to a foundation incorporated to assist in the funding of a Dutch hospital;
• Corporate governance and contractual advice to a Dutch subsidiary of a large privately owned company which designs, manufactures, and markets high-tech dental equipment such as digital imaging products and dental care units, headquartered in Helsinki;
• Contractual and corporate advice -also in view of its cooperation with one of the largest hospitals in Amsterdam- to a foundation active in dentistry;
• Employment law advice to several clinical research organisations;
• Public procurement advice to several Home Care Organizations (e.g. Vierstroom);
• Advice to a Dutch hospital (Catherina Ziekenhuis Eindhoven) related to financing arrangements;
• Corporate and employment law advice to a Dutch clinic hospital (Medisch Centrum Haaglanden) which hospital amongst others focuses on the education of medical specialists and nurses;
• Advice to a hospital relating to the outsourcing of the medical laboratory;
• Setting up a medical academia relating to professional / management education for doctors. The academia is a cooperation initiative between Erasmus University, VVAA and the Dutch Professional Medical Association.
• Advice as to the entanglement of associated medical specialists (Beatrix Ziekenhuis);
• Legal demerger of and related corporate advice for a bio manufacturing and life science research company;
• Advice in relation to joint ventures of companies in the domiciliary care field;
• Review service agreements for a company active in producing technical equipment in the health sector.

Information - Eversheds Faasen

Please do not hesitate to contact us for further information.