A ‘new normal’ when it comes to the TGA regulation of medical devices?

Key points: In Australia responding to the urgent need for COVID-related medical devices the TGA implemented a number of emergency measures to bring medical devices to market faster. The emergency regulatory measures have proven agile, flexible and successful with the potential risks to the public well managed. The regulatory measures have potential utility beyond the … Read more

The European Commission considers the future of health in Europe with new Pharmaceutical Strategy and Action Plan on IP

The European Commission has this week published a wide-ranging and ambitious Pharmaceutical Strategy for Europe, and an Action Plan on Intellectual Property. Pharmaceutical Strategy for Europe The new pharmaceutical strategy for Europe is a key pillar of the European Health Union, which President von der Leyen called for in her 2020 State of the Union … Read more

COVID-19: Pressure Points: Supply Chain Difficulties – new global guide, including IP, advertising and collaboration issues

Herbert Smith Freehills has published a new global guide on supply chain difficulties arising from the COVID-19 pandemic and associated restrictions and solutions. Supply chain difficulties are at the heart of the pressures facing businesses during the COVID-19 pandemic. In our latest guide we look at supply chain pressure points and what is being and … Read more

COVID-19: Pressure Points: The UK Government confirms that it will indemnify ventilator manufacturers against IP infringement claims

The UK Government has issued an indemnity in relation to claims brought against the manufacturers of new ventilators produced to deal with the COVID-19 pandemic in the UK as part of the Government’s campaign for rapidly manufactured ventilator systems (RMVS).  A letter from Michael Gove MP to the Chair of the Public Accounts Committee (3 April) confirms … Read more

The impact of COVID-19 on competition law in the pharmaceutical sector

The global COVID-19 pandemic has, to an extent, re-directed some of the actions and focus of competition authorities, which are placing increasing scrutiny on several strategic industries to ensure they do not profit from the crisis. Some of these developments, as outlined below, are relevant to the pharmaceutical industry (for information on COVID-19’s more general … Read more

COVID-19: PRESSURE POINTS: Order SND/326/2020, of 6 April, which establishes special measures to grant prior operating permits for facilities and to use certain medical devices lacking CE certification as a result of the medical crisis linked to the COVID-19 outbreak (Spain)

The Order establishes a number of special measures for medical devices listed in the annex to the Order, surgical facemasks and surgical gowns: Permit.  A prior operating permit for facilities (as established in article 9 of Royal Decree 1591/2009, of 16 October, which regulates medical devices) will still be required to manufacture medical devices necessary … Read more