How can genetic data collected by in vitro diagnostics providers be legitimately processed under GDPR?

In vitro diagnostics offerings necessarily involve the collection of vast amounts of sensitive health data. This information is an invaluable resource for better understanding the genomic basis of disease, and making improvements to diagnostic offerings. It is imperative that stakeholders get it right when it comes to processing individuals' data and maintaining public trust, so that they can continue to exploit these rich datasets. Over the coming weeks HSF will publish a series of posts exploring issues that arise when processing this kind of data in accordance with the GDPR. Read more

Regulatory reform for software-based consumer health products – new regulations provide clarity but can they keep up with the technology?

Mobile health apps and devices are everywhere (“mHealth”), with Australians now the biggest consumers of health apps per capita. The TGA recently released a suite of reforms on software-based medical devices and consumer health products to better address this area. But what are the impacts on developers, and will the regulations be “future proof” as … Read more

EU Action Plan on IP – the challenge ahead

Herbert Smith Freehills' European IP team have had a feature article on the EU's IP Action Plan published in the April edition of PLC Magazine – see EU Action Plan on IP – the challenge ahead here. The article looks at the current challenges for the EU in relation to IP, its key focus areas and plans for future regulation and legislation, including: • The Unified Patent Court (UPC) • Supplementary Protection Certificates (SPCs) • Compulsory licensing • Standard Essential Patents (SEPs) • AI and emerging technologies • Counterfeiting • Designs • Geographical Indications • Data • The Pharmaceutical Strategy for Europe Read more

Judicial review – another weapon in Big Pharma’s disputes arsenal?

The life sciences and healthcare sector is subject to complex regulation and decisions of Government bodies can have a significant impact on the availability and production of pharmaceutical products.  Where Government bodies take decisions of this nature, and there is no other recourse available, judicial review provides an avenue to healthcare companies and others to challenge Government decisions. Herbert Smith Freehills has had a practice note published in Practical Law which considers the various grounds of judicial review, the application of these grounds to specific cases in the healthcare sector and some particular considerations to be taken into account when making a judicial review application. Read more

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 Trade and Cooperation Agreement and its impact on IP, Pharma and Medical Devices

The final Brexit agreement, the Trade and Cooperation Agreement was agreed between the UK and the EU on 24 December 2020. Within this agreement are provisions that set out the standards expected to be recognised (mutually) between the EU and the UK in relation to intellectual property (including SPCs and trade secrets). There are some provisions concerning pharmaceutical regulation and product standards, but overall there is a lack of mutual recognition, with the consequence that, for both pharmaceuticals and medical devices, there are now effectively two separate regimes for the EU and the UK. Read more