Justice Manson of the Federal Court recently ordered the minister of health to issue a notice of compliance to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie's HUMIRA. The minister of health had completed its review of Fresenius Kabi's new drug submission for IDACIO; the only outstanding issue was whether Fresenius Kabi had addressed the patents listed on the Patent Register in respect of HUMIRA.

The Patented Medicine Prices Review Board recently published the final version of its guidelines which operationalise the amendments to the Patented Medicines Regulations scheduled to come into force on 1 January 2021. This article provides a brief summary of the final framework for the price review process and highlights changes relative to the June 2020 draft guidelines.

The European Union recently published a communication on the European Union's short-term health preparedness for COVID-19 outbreaks, which aims to reinforce the European Union's preparedness and create a coordinated response capacity to counter further outbreaks of COVID-19. This article highlights the main measures provided by the communication, including with regard to testing, contact tracing and medical countermeasures.