Regulatory & compliance

Germany: Reimbursement of Digital Health Apps – A “World First”

Eda Zhuleku

The Digital Healthcare Act (Digitale-Versorgung-Gesetz DVG) was published in the German Federal Law Gazette (Bundesgesetzblatt) on 18 December 2019 and entered into force on 19 December 2019, having been passed by the German Parliament (Bundestag) in November 2019. Among other regulations intended to expand the digitalisation of the healthcare system, the law will allow the Read More

France defines medical situations in which physicians can exclude generic substitution

Eveline Van Keymeulen

On 19 November 2019, pursuant to Article 66 of the 2019 Social Security Financing Act (LFSS), the implementing order that indicates the medical situations in which physicians may exclude substitution on prescriptions was published (Order of 12 November 2019). For background information, see our previous blog post French 2019 Social Security Financing Act introduces new Read More

Dutch Minister of Care announces mandatory “base stocks” to prevent medicine shortages

Sophie van Asten

On 4 November 2019, the Dutch Minister of Care wrote a letter to the House of Representatives, proposing a solution for medicine shortages. In order to prevent shortages, additional stocks of medicines should be built up by obliging medicine manufacturers and wholesalers to build up mandatory buffers (“base stocks”) of five months’ duration, starting in Read More

France: Details of hybrid groups register published

Jeanne Fabre

In accordance with Article 66 of the 2019 Social Security Financing Bill (PLFSS), the details of the hybrid medicines register have been published through a decree on 20 November 2019 (see our previous blog post:  French 2019 Social Security Financing Act introduces new healthcare measures). Decree No 20169-1192 specifies the registration procedure and removal of Read More

German courts confirm sales bans on CBD containing food

Eda Zhuleku

According to the latest version of the EU Novel Food Catalogue, EU regulators consider that CBD-containing foods and dietary supplements are classified as novel foods. The Novel Foods Regulation (EU) 2015/2283 defines as “novel” any food which has not been used for “human consumption” to a significant degree within the EU before May 1997. As Read More