Medical Progress as a Challenge for Public Law
Problems and Current Discussion
The healthcare sector of Switzerland, in the EU Member States and in almost all Western Countries is characterized by a rapid development of medical and biotechnological opportunities. In the 20th century mayor medical breakthroughs have been achieved ranging from new pharmaceutical products such as biopharmaceuticals, tissue engineering and new transplant opportunities to stem cell research embryonic research. Particularly over the last decades, human research and the development of pharmaceutical products made an immense leap forward. Beside countless important breakthroughs in medicine and research, international cooperation was one significant factor for the scientific progress.
Nevertheless how fast science developed, legislation always lagged behind. Developing the necessary legal framework for medical and biotechnological research took much longer than discoveries of new procedures and drugs. This discrepancy between fast advancing research reality and slow implication of new legislation led to legal insecurities, especially when working in an international environment, for example in international research and multicenter studies.
Not only are many countries – including Switzerland – far behind with their legislation, there are often also major differences within the international comparison. This leads to legal uncertainties for the researchers, universities and the pharmaceutical and medical industry on the one hand. It raises also fundamental human rights questions as guaranteed in the Swiss Federal Constitution, the European Charter of Fundamental Rights as well as in the European Convention of Human Rights and the Convention of Human Rights and Biomedicine.
This development calls for the right balance between the legal interests and for new legislation to set the right legal environment. One example is the new Swiss Human Research Act of 2014 which raises various legal questions which affects the daily research business. Other medical and biotechnological fields of law are still waiting for an appropriate regulation. This is the future task of public national law which needs to respect the European and international legal environment.
In addition, the healthcare sector comprises some of the already most highly regulated areas: Besides the pharmaceutical sector which is characterized by strict market authorization procedures for pharmaceutical products the sectors of health insurances, hospitals and care facilities as well as medical professions, medical practitioners´ associations and pharmacies are highly regulated by national laws and are often subject to social policy and safety goals. In Switzerland as well as in all EU Member States the national healthcare systems are not only an important economic sector but are also characterized by constantly increasing costs due to the demographic change and longer life spans of the population, increasing demands and technological progress because of new treatment options and pharmaceutical products which are generally protected by patents and data exclusivity. This leads to the need to control costs and decrease public spending which raises several questions ranging from IP law to the question of market liberalization and the application of competition law to questions of social policy such as the principle of solidarity and distributive justice.
As a result of these developments there are numerous questions of public health law which need to be solved in the future and need to take into account health policy as well as health economics.
Examples of Topics for Legal Research
There are still numerous legal questions concerning the regulation of medical and biotechnological developments, some of them are even not yet foreseeable. It is, however, of fundamental importance to set the right legal environment to enable medical and biotechnological research but to also discourage abuse of technological opportunities now and in the future.
Some topics for legal research which have not yet been properly researched are for example:
- Relationship between IP, regulatory and competition law
- Legal setting for stem cell and embryonic research
- Human research under the new Swiss Human Research Act
- International multicenter studies and the applicable law
- Cost control over new medicines and pharmaceutical products
- Reimbursement of healthcare costs under the national social law
- Right of health in constitutional and international law
- Healthcare in the EU and Switzerland and the EU Charter of Fundamental Rights
- Surrogate maternity and paternity and the principle of equality
- Orphan diseases and decreasing costs for orphan drugs
- Epidemics such as Ebola and the legal possibility of compassionate use
- Legal environment for off label use medicines
- Pediatric care and pediatric medicines
- Internal Market Regulation of the EU, free movement principles and EU patient mobility legislation and implication for Switzerland
- New EU Clinical Trials Regulation and implications for Switzerland
- Development for new devices and medical apps
- Legal setting of hospital planning and financing including the Swiss diagnosis related groups system
- Legal questions concerning a unified health insurance fund in Switzerland
- The applicability of public procurement law in the health care sector
- Autonomous adoption of EU pharmaceutical law
- Autonomous adoption of EU food law, including the Cassis de Dijon principle and several EU regulations and directives (such as for novel food or health claims)