Attorney medical law

Competent advice is a matter for experts

In the last twenty years medical law has developed away from being a marginal area of law to become a main topic in the various fields of legal expertise. However, medical law is by no means a "new" area of law. A selected group of lawyers was exclusively concerned with advising companies from the health sector long before there was such a thing as a specialist lawyer for medical law. Nowadays the market has a relatively large number of specialist lawyers for medical law, although in our experience legal advice for entrepreneurs and freelance professionals in the health sector is still the domain of just a few colleagues who appear time and again in various constellations when clients are being represented.

The partner after whom our law firm is named already concerned himself with the legal issues of medical law at an early stage and has made a name for himself in the field with numerous publications. Thus the section on "treatment documentation" in the "Heidelberger Kommentar Arzt-, Krankenhaus- und Medizinrecht" is commented on by Dr. Robert Kazemi as co-author and it was only recently that he wrote the commentary on the data protection rules in Social Security Statute Book (SGB) X in the renowned "Kasseler Kommentar zum Sozialversicherungsrecht". He is also an author for numerous publications such as "MedR", "Gesundheitsrecht", "DZW" and other publications. We are also the permanent advisers for numerous players the health sector, thus replacing the in-house legal department.

Medical law is an extremely complex area of the law, which, in addition to experience, mainly requires profound knowledge of case law, legislation and the legal literature. So legal advice on issues of medical law cannot simply be provided "on the side".

Establishment

Legal advice for medical practitioners and dentists and also for pharmacists often begins in connection with the question of establishment. This could be because an entrepreneur is thinking of retiring and therefore enters into negotiations with a successor, or because a medical practitioner, dentist or pharmacist who wishes to set up a practice is seeking legal advice prior to and in connection with negotiations with the seller. The sale of a medical undertaking, which also includes a medical or dental practice, can hardly be compared with the classical sale of a business, as it is subject to many special laws which it is vital to comply with. In this connection think, for instance, of the medical confidentiality and data protection law and also of the fact that the sale of a business often depends on obtaining official approvals. Those who seek professional advice from professionals well versed in the legal issues of medical law are clearly at an advantage, as errors in this area can not only be expensive, but may also be of relevance for questions of criminal liability or regulatory issues. So a contract for the sale of a practice, a contract for the sale of a pharmacy or a health centre should never simply be taken from a drawer, but always tailored to the individual circumstances. Those who seek help from experienced advisers benefit in many respects from their previous knowledge, not least from the point of view of costs. We do not need to first acquaint ourselves with the field of medical law. These are issues that concern us every day. Only in this way is it therefore possible for us to advise our clients on questions of establishment in a way that offers value for money, no matter whether we ultimately bill on an hourly basis or – as is so often the case – on the basis of a fixed fee. Those who try to cut corners often not only end up paying more, but far too much.

Forms of cooperation in the health sector

In recent years a clear trend towards networking has emerged in the healthcare sector; pharmaceutical companies, hospitals, medical practitioners, dentists, pharmacists, manufacturers of medical products and devices and members branches of other healthcare professions are increasingly working together. This improves the quality of treatment and can bring enormous economic advantages. Nevertheless it must be remembered here as well that not everything that makes economic sense or is economically attractive is lawful. The Federal Court of Justice, for instance, has concerned itself with the silent participation of dentists in a dental laboratory with the simultaneous obligation to send all laboratory work required by the dental practice to only this dental laboratory. Not surprisingly the 1st Civil Division of the Federal Court of Justice reached the conclusion that such agreements are null and void due to an infringement of the law governing the dental profession and the mandatory protective provisions of the Unfair Competition Act (UWG, section 4 (1)). According to the official headnote of the decision, it represents an undue and uncalled-for influence on a dentist's freedom of diagnosis and therapy if dentists enter into a contractual obligation to commission a dental laboratory run by a limited liability company with all dental laboratory work required in treating their patients and the dentists participate in the profits of this limited liability company through a special corporate construction. The batch preparation of medication by pharmacists also has its limits. Fictitious partnerships between medical practitioners and dentists can entail considerable consequences both in terms of criminal liability and in terms of billing law. Collaboration between established medical practitioners and hospitals is another area that has continually led to problems in the past. Here there is a particular need to explore and clearly set the boundaries.

Advertising law in the healthcare sector

The increasing competition in the healthcare sector places the focus of business decisions more and more on the subject of marketing However it is not only classical competition law that applies here. It is also necessary to comply with the law governing the advertising of medicinal products and the Medical Devices Act. Many other special laws, both German and European, requirements established by case law and the provisions of the various professional codes or codes of conduct sometimes place restrictions on advertising activities. How far such advertising activities now go is shown by a judgement of the European Court of Justice of 2008. In this case the court had to consider television advertising for medical and surgical treatments. Aggressive advertising praising the supposed quality of one's own services is something we are mainly familiar with from the field of industry and commerce. The savings mentality of the German population is something that can be especially well exploited for advertising purposes. "The cheaper the better": why not apply this principle to the healthcare sector as well?. The advertising slogan "Zahnersatz zum Nulltarif" (dentures for nothing) has aroused particular attention in this connection and our law firm has been instrumental in largely putting an end to it. In the recent past, advertising with vouchers, bonuses and other perks has often been the subject of litigation before German civil courts. With instruments like this pharmacies, for instance, try to win customers' loyalty for their own range of products and to prevent "pharmacy hopping". In the past we have reported numerous more or less innovative models and discussed their legal classification. For a long time the principle applied outside specialist circles that it was not allowed to advertise using images of the effect of a treatment by showing comparisons of the physical condition or physical appearance before and after the treatment. This ban on advertising was anchored in section 11 (5 b) of the Advertising of Medicinal Products Act (HWG). It was precisely in the depiction of comparative images of the success of a treatment that German legislators saw a special risk of undue influence being exercised on patients. In view of the fact that a person's health represents a sensitive asset, medical information was subject to special restrictions. After a number of liberal decisions from Europe, German legislators reacted in November 2012 with the 2nd Act on the Amendment of Regulations Governing Pharmaceutical Law and Other Regulations (2. Gesetz zur Änderung arzneimittelrechtlicher und anderer Vorschriften) and slackened numerous bans on advertising contained in the Advertising of Medicinal Products Act. The statutory health insurance funds are also active players in the "competition" for patients and insured persons; here they fall within the scope of application of the Unfair Competition Act. Thus the regional social court of Rhineland-Palatinate has found the advertising of a statutory health insurance fund in which it called upon its customers to use the services of a certain mail-order pharmacy to be contrary to its duties. The health insurer (BKK) being sued by a pharmacist in this case had sent advertising brochures of the Dutch mail-order pharmacy, "E", to an unknown number of its members and, in an accompanying letter, advertised a "personal bonus" that the insured would receive from this pharmacy on prescription medicines with co-payments and on over-the-counter medicines under the heading "Threefold guarantee from E: affordable, safe and convenient". In a judgement of 11 October 2013 the Dusseldorf regional court, in proceedings instigated for a client, also prohibited numerous advertising statements in relation to the sale of a "Dentures Card" (judgement of 11 October 2013, 38 O 113/13). The advertising promised supposed advantages due to the "quality of a German dental laboratory" with statements such as "dentures at attractive prices" and the claim that "all patients can determine which dental laboratory makes their dentures". From the examples above it is already clear that advertising in the healthcare sector cannot do without legal scrutiny. This should already take place in advance so that expensive advertising does not turn out to be a total waste that – if a warning is issued or a court should even impose an injunction – achieves the exact opposite from what is intended.

Labour law, billing law and general civil law

Finally, the daily running of a healthcare enterprise (medical/dental practice, pharmacy, pharmaceutical company, hospital etc.) gives rise to numerous questions, such as labour law issues. The engagement of panel physicians, for instance, is no simple matter here either, but follows strict rules and approval requirements. Moreover, receptionists, pharmaceutical representatives and students assistants not only need to be selected with care, but also integrated into the organisation by contract in accordance with the law and let go again if necessary, taking account of the employer's economic interests. The same applies when commissioning external service providers, whether in the context of outsourcing, the procurement of material or, for instance, when relocating, archiving and destroying documents and files. Here too we can assist you with the experience we have gained in the permanent support of and provision of advice to entrepreneurs in the healthcare sector. Our concern is to work with you to find a legal solution that does not lose sight of your entrepreneurial activities. "It can't be done, impossible" is therefore something that you will only hear from us in the rarest of situations. We look for solutions, not hindrances!