Hospitals, pharmaceutical and medical device companies, organisations of health care professionals, etc., are increasingly merging together even on a cross-border level. In view of this kind of globalisation in the health care sector, our three law firms specialised in health care have decided to create a European network specialised in medical law and health law, named EuMedLex. With our law firms we aim to build a highly specialised network to meet the demands of customers in this European and globalised market. We are pleased to send you a newsletter that deals with some recent developments at the European level that are of importance for health care actors. They relate to medical devices, EuMedLex will inform you regularly through publications, lectures, brochures etc. of future developments that may be of interest of our customers in the health care sector. EUMEDLEX is a network of medical law firms.
1. The importance of e-health
- Electronic health records in hospitals
and DNA banks
The European single market in health care is developing and cross-border activities in health Member States are working on the introduction care are increasing. Patients tend to be treated of electronic health records, i.e. comprehensive more in other Member States than in the past, medical records providing ready availability of especially if waiting lists exist in the country health data for medical treatment and allied where they live. Moreover, doctors ask for more, Electronic
and more varied, telematic information from health
their colleagues. Hospitals are creating hospital The Data Protection Directive provides several records
networks that store a great deal of medical data on measures to be taken by the controller of a file in patients. Patients often order medicinal products order to guarantee the right to privacy of the data through the Internet from pharmacies that are subject. However, article 8 of the Directive is too located in other countries. All these developments vague to provide for good legislation at the EU- are related to e-Health. E-health refers to level with regard to the further use of data and the information and communication technologies for creation of electronic health records nation-wide or in big hospital chains. The Article 29 Working Party is not convinced The European Commission has invested in the that relying only on the obligation to professional past in several research programmes related to confidentiality provides sufficient protection. If e-Health. Moreover, the European Commission more persons may have access to the record established an action plan for a European E-Health because the records are kept by hospital chains, area in 2004. However, the Commission observed more specific safety measures must be taken and a low implementation of telemedicine applications the patient must be asked for consent as to which in real-life medicine and is now identifying the categories of persons may have access to the barriers and triggering factors. The Commission plans to issue a Communication on Telemedicine and innovative ICT tools for chronic disease University centres also often store blood and human tissue samples that can be used for research purposes. Since DNA sequences of 2. Towards more European rules
samples can be analysed via and stored on computers, it is obvious that the distinction between the processing of human tissue and the e-Health is important. The organisation of processing of health data becomes small. Several health care is up to the Member States but e- European documents already refer to the use of Health (including telemedicine services) has the human tissue, such as Directive 2004/23/EC and potential to be used in cross-border settings. the Regulation on Advanced Therapy Medicinal The Commission has a specific mandate to Products. However, these documents remain too address cross-border care issues which cannot vague to provide Member States with guidance on be addressed on a national basis alone (see further use of tissue, blood and DNA sequences for also EUROPEAN COMMISSION, “Questionnaire. Reimburse-
Telemedicine. I2010 eHealth sub group Members”, ment and
2007, p. 2.). This is why it is desirable that e- - Reimbursement and telemedicine
Health gets much more attention at the EU-level. Several issues need to find a more European The E-Commerce Directive does not regulate the reimbursement of telemedicine services, which falls under the competence of the Member States. 3. Medicinal products and the Internet
European and international telemedicine projects have often failed because they were too expensive The EU has enacted several directives and for the patients and reimbursement by their health regulations on medicinal products and medical insurance funds was not possible. An essential condition for reimbursement was never fulfilled, i.e. the physical presence of the (tele)-physician However, it is important to verify how ICT and with the patient at the moment of performing in particular the Internet is playing an important the medical treatment. The refusal to reimburse role in the selling of medicinal products. The medical costs if there was no physical presence Community Code of medicinal products regulates might have been reasonable in a period without marketing authorisations for medicinal products, ICT. It could be argued that a physician who only manufacture and distribution of medicinal listens to a patient on the phone cannot make a products, publicity issues, etc. but does not good diagnosis and that therefore reimbursement have specific rules on the internet and medicinal would not be possible. The revolution in the ICT sector makes it perfectly possible nowadays to collect the required medical information for a It is legal, at least for OTC products, to buy diagnosis at a distance without being physically medicinal products without being physically in the present. The question is then whether it is still pharmacy. However, Member States will enact reasonable under EU law to refuse reimbursement different rules for prescription medicinal products. just because the physician did not see the patient Some Member States may argue that online selling should not be legal while other Member States may accept ordering prescription products through the - Liability and telemedicine
internet. To ensure that medicinal products are sold safely over the internet it might be desirable We believe that the EU may play an important role for new rules to be enacted at the EU level. even with regard to the liability issue. It is not good for the free movement of patients and health care services in Europe if patients are subject to different liability schemes. Some countries like Stefaan Callens
France and Belgium have recently enacted so called Lawyer at the Brussels bar
no-fault legislation related to health care. The no-
fault issue is already considered in the EU Directive on products liability but is being increasingly expanded to other domains like health care delivery. Good compensation for patients if something goes wrong during a medical intervention might indeed be considered an important right for patients. It is not good for patients or health care professionals if this right is regulated all over Europe in a different way. This will not promote the use of telemedicine. Therefore, EU legislation should require Member States to provide similar rules for compensation; this would enhance the free movement of patients and health care services and ultimately the use of e-Health tools. COMPATIBILITY BETWEEN MEDICAL DEVICES AND INCURRED RESPONSIBILITIES
1. Introduction
3. Directive 93/42/EEC of 14 June 1993

(In) compatibility between medical devices: in Annex I concerning Essential Requirements brings into conflict manufacturers, some deals with compatibility between medical devices affirm to be compatible with those of other Point 9.1: “If the device is intended for use in combination with other devices or quality and performance of the combination, equipment, the whole combination, including must not impair the specified performances of where applicable, other persons, medical the devices. Any restrictions on use must be practitioners or private/public hospital indicated on the label or in the instructions for personnel, and make them responsible for non-observance of the instructions for use instructions for use must contain the following particulars: […] (c) if the device must be Directive
2. Directive 2007/47/EC of 5 September 2007
installed with or connected to other medical 2007/47/EC
devices or equipment in order to operate as on medical devices did not modify either the required for its intended purpose, sufficient provisions of Article 12 of previous Council details of its characteristics to identify the Directive 93/42/EEC of 14 June 1993 about correct devices or equipment to use in order to particular procedures for systems and procedure packs, or the definition of “accessory” referred to in Article 1.-2.(b) as “an article which while Therefore, an obligation as to security and not being a device is intended specifically by its performance of the assembly, as well as an manufacturer to be used together with a device obligation to communicate restrictions on use in to enable it to be used in accordance with the the notice and in labelling, is clearly imposed in the use of the device intended by the manufacturer of the device”. As Article 1.-1 provides that “accessories shall be treated as medical devices in 4. French Health Products Safety Agency
their own right”, for the purposes of the Directive (AFSSAPS)’s clarification of 14 February
accessories are not themselves medical devices but are “treated as” medical devices. AFSSAPS published a Clarification to users in which manufacturer puts together in order to place them on the market as a system or procedure pack on “It is essential to verify the assertions of the his own responsibility as to the result.
manufacturer of the medical device announced as compatible in its instructions for use. Indeed, they The difficulty appears, in practice, when two are the fundamental element which allows explicit or several producers’ medical devices are put determination of the claims which engage the together by the users while a producer of at least one of the elements of the combination does “When a manufacturer of a medical device not approve this assembly and mention it in the announced as compatible with another does not mention in the instructions for use the list of medical devices considered as compatible, the his civil and penal liability if the medical device user may ask the manufacturer for confirmation of concerned becomes dysfunctional and causes “The user’s responsibility is engaged for using medical devices outside the scope of the Numerous declarations of incidents are registered within the framework for oversight of medical devices and users, hospital pharmacists, 5. Conclusion:
doctors, bursars of public and private health establishments, and patients at home have to Any actor in the market should be aware of the exercise caution and rigour in dealing with such risks, as they often rush to take advantage of a distributor in declaring "compatible" an promotional prices on accessories when the association of an accessory (that he sells) with qualities claimed by the distributors do not equal the medical device of another manufacturer those of the original medical devices of proven who rejects the assertion of compatibility and limits his guarantee to associations of medical devices which he enumerates, a user in assembling elements the various manufacturers of which did not unanimously Isabelle Lucas-Baloup
Avocat à la Cour de Paris
constitute a high-performance medical device.
Instructions for use and certificates of compatibility engage the responsibility of the manufacturers and the distributors who establish them. If requirements are void, updated, exceeded by the technical or technological evolution of one of the elements of the combination, and the relevant material is not revised at the appropriate time, the author of a deceitful assertion engages GERMAN PHARMACEUTICAL MARkET AND COST-BENEFIT ASSESSMENT
IQWiG new method paper encounters heavy
standards of health economics. Especially criticism
the cost structure of drugs from the past encounters scepticism, since pricing is influenced The German pharmaceutical market and its by development of generics and fixed pricing Pharma-
significant role in international pricing is confronted schemes. This gives way for the question at what ceuticals
with a potential new barrier to market entrance. In recent years reimbursement restrictions have An example: AChE-inhibitor’s DDD cost was at already been imposed by the Joint Committee 1.08 € in the 90s. They are down to 0.11 € by (GBA) some of which are based on benefit now. Substantial benefits from a new therapy will assessment reports issued by the newly founded exceed this cost by far. What shall the basis of an Institute for Quality and Efficiency in Health Care (IQWiG). Germany has followed the UK (NICE) and France (HAS) in Health Technology Assessment The most recent statement of the highly reputed with a different model. IQWiG merely lays the ‘Verein für Socialpolitik’ (the largest German grounds for reimbursement decisions without own speaking community of economists founded in decisive power. On this basis, however, the vast 1837) focuses on five major points of criticism majority of drugs assessed so far, e.g. short acting insulin analogues, atorvastatin and montelukast have been classified as “without additional benefit” The suggested cost-benefit-assessment is Cost-benefit-
and subject to restriction in reimbursement and confined to the perspective of the Statutory assessment
pricing has followed or is expected. Latest legal Health Insurance (SHI). Cost effects in other reforms have introduced a new task for IQWiG’s parts of the social security system need to be director, Professor Peter Sawicki. Since 1st April taken into account to be in line with the legal 2007 cost-benefit-assessment shall be undertaken preconditions according to §35b SGB V.
for drugs with patented substances and other The method paper neglects basic categories drugs ‘that are of particular importance’.
of relations between cost and benefit. Thus important questions of economic evaluation On 24th January 2008 IQWiG presented a method are not been dealt with in an international proposal based on an ‘Efficiency Frontier Analysis’. The innovative concept also includes an analysis of There is no precise definition of the term budget impact. The ‘Efficiency Frontier’ is a graphic ‘benefit’ in the paper. The requirement for presentation determined on the one hand by determining a clear and transparent procedure benefit units and cost units on the other. According to determine different benefit components is to the IQWiG the cost axis illustrates the costs that are accrued in order to achieve the specific benefit The concept of determining an efficiency previously determined. This graphic presentation frontier is unrealistic since it is based on will be used to ‘make it clear at a glance which the assumption that all drugs included in existing therapies are efficient and which are not.’ the procedure can be assessed in the same (
manner. However, there is no scientific or normative reason that can support such a This method has been presented to the public on several occasions and is subject to severe According to the paper economic evaluations criticism. The pharmaceutical industry and many are confined to the particular indication specialists in health economics agree that such (disease). If reimbursement decisions are a procedure does not at all suffice the legal based on such a strategy the impact on the requirement of taking into account international allocation of resources is being neglected. If the methodology will be accepted as suggested the impact on international pharmaceutical parameter for benefit like QALY is required pricing might be noteworthy. Pharmaceutical to raise reimbursement decisions of the Joint innovations would be assessed on the basis of an efficiency frontier that is based on price development in particular indications and be All over all the ‘Verein für Sozialpolitik’ deems this subject to a somewhat arbitrary scale. Looking proposal of cost-benefit-assessment as unsuited to at the importance of the German market in terms comply with legal and practical requirements.
of international pricing these effects will be more than national. Facing this predicament some within What are the next steps? According to recent the pharmaceutical industry feel that producer- experiences with IQWiG experts consider it to-funds negotiations on pharmaceutical pricing improbable that the public discussion will bring might be favourable. However, the public dispute about major changes to IQWiG’s new methodology. on these issues in the course of this year will be a The legal frame work does not foresee a specific accountability of IQWiG to the Joint Committee nor to the Ministry of Health concerning the methods. Prof. Dr. Dr. Christian Dierks
However, it can be expected that IQWiG’s Board of DIERkS + BOHLE Attorneys, Berlin
Directors will have some influence on the further development. Since the board is dominated by funds and health care professionals (the industry is not represented) the cost containment potential of the method might be the decisive factor.


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Update 081029 cd update 17

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