Technological developments in the life sciences and the ever-changing reality in today’s healthcare (particularly due to the coronavirus) have recently created significant opportunities and challenges in the biomedical industry. At the same time, healthcare regulation is becoming relevant to a growing number of players and sectors.
Gornitzky & Co.’s Biomed, Pharma and Healthcare practice provide legal services to some of the world’s largest companies – pharmaceutical companies, manufacturers and distributors of medical equipment and instruments, and companies that offer breakthrough technologies in the medical and healthcare industry – in agreements with the State, in tenders of Israeli Health Maintenance Organizations (HMOs) and other medical institutions, and in various regulatory proceedings. In addition, we advise companies that use or are developing digital health tools, such as tools for monitoring and tracking vital signs, wearable devices and telehealth services. We also represent companies engaged in developing means for combating COVID-19 and other pandemics and to monitor their spread.
The legal services that we provide in this field include, among others
- Provision of consulting services to our clients with respect to the legal and regulatory requirements in connection with the licensing of medical accessories and instruments, the licensing of pharmaceuticals and cosmetics, research and development, etc.
- Representation of companies bidding in tenders of HMOs and other medical institutions;
- Provision of legal services to clients on unique questions of data privacy and data security, with respect to medical information, including in connection with data anonymization, using information for clinical research purposes (including ‘secondary use’ of data), and the transfer of medical information outside of Israel.
- Advising entities that offer products and services in the medical and healthcare field, with respect to the unique anti-corruption and anti-bribery aspects, and other aspects of compliance in that field, including in relation to restrictions on the financing of conferences and research studies, advertising, etc.;
- Legal advice with respect to various intellectual property matters relating to the Biomed sector, including issues of an intellectual property strategy, ownership arrangements and joint development, licenses, and others.
- The handling of investment transactions, mergers and acquisitions, and IPOs, in connection with companies in the biomedical and healthcare industries (including medical cannabis), including due diligence in connection with the unique aspects that pertain to these industries, and obtaining permits and licenses from government authorities.
- Advising local and foreign clients on medical cannabis regulation in Israel, including on issues of research and development, obtaining licenses and permits from the Ministry of Health, and others. This includes the representation of clients vis-à-vis the Medical Cannabis Unit of the Ministry of Health and the provision of legal services in connection with all of the stages of the chain of supply of medical cannabis products and in connection with the ongoing requirements of companies that are active in that sector.