Osborne Clarke Health Check
International regulatory timeline
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International regulatory timeline
The Health Check series features Osborne Clarke lawyers taking a critical look at developments in the life sciences and healthcare sectors. Through a ‘health check’ style appointment, the series aims to equip companies with strategies to respond to regulatory changes. The series includes short webinars, podcasts, infographics, and insights, all focused on providing practical strategies to navigate regulatory changes.
Regulators must constantly balance initiatives to boost innovation against measures to protect patients and consumers. In each session, we apply our Legal Thermometer to take the temperature on a key development, asking: is it too hot, too cold, or just right to promote growth in the sector?
Osborne Clarke Health Check - Spring Series 2025
Our Spring 2025 series of Osborne Clarke Health Check featured short webinars, podcasts, infographics and insights – all focused on equipping companies with practical strategies to respond to regulatory change.
You can request the recordings and explore all the tools and tips from the sessions below.
Regulatory investigations: could your product end up under the regulator's microscope?
Sodium valproate, opioid products and hip implants are just some recent examples of products that have attracted regulatory investigation. An increased focus on patient safety, combined with a greater abundance of patient data and a shifting regulatory landscape in the EU and UK have all combined to drive up the agenda the prospect of investigations into the safety performance of life sciences products.
We will examine:
- The implications of the MHRA's new focus on "risk proportionate regulation"
- Mitigating the side-effects of regulatory scrutiny: product recalls, personal injury litigation risk, negative PR
- Pre-empting common questions from regulators
Pharmaceuticals: alternative routes to market - worth the detour?
The UK government is pushing for more investment in the UK's pharmaceutical industry and recently announced £650m of funding initiatives. But how should companies navigate the regulatory system to bring medicines to the market, particularly as the UK system diverges from the EU model? In this 30 minute webinar we examine the pros and cons of some alternative routes to market for medicines, including:
- Medicines for compassionate use
- Orphan Drugs
- Borderline products
- The UK's new International Recognition Procedure (the IRP), taking effect on 1 January 2024
NHS procurement: introduction to how the NHS buys from the private sector
The UK's NHS must comply with public procurement legislation when it buys medical devices, medicines and services or commissions healthcare services. The legislation is being overhauled with the introduction of the Procurement Act in 2024, and the long awaited introduction new NHS Provider Selection Regime, expected by the end of 2023. In this 30 minute webinar, we will examine:
- How public procurement legislation impacts how the NHS buys non-healthcare goods and services, and what this means for suppliers
- How the NHS Provider Selection Regime will impact how the NHS commissions healthcare services, and what this means for suppliers
- The mandatory net zero commitments, and other social value commitments, that suppliers must make in order to do business with the NHS
How to stay well: the regulation of wellbeing products and services
As the global market for wellness and wellbeing services continues to boom, the regulatory landscape has struggled to keep pace with innovation in wellbeing trends. In this 30 minute webinar, we look at what businesses promoting new products and services should consider when developing and launching wellness offerings. We'll look at:
- The potential for regulation by the MHRA, Care Quality Commission and the Food Standards Agency
- Treading the line between wellbeing services, cosmetic procedures and healthcare services
- Practical tips for businesses
Our tips for manufacturers of wearables, both for the 'wellness' market and the clinical market, covering issues affecting software, decentralised clinical trials, advertising and mitigating the effects of personal injury litigation.
A tool to help life sciences and healthcare companies review and mitigate risks associated with performance data, regulatory status, product literature, supply chains and early decision making.
Strategies to reduce the liability and regulatory risks that affect innovative products
Innovative products come with a heightened risk of attracting product liability litigation and regulatory investigations. As the EU Medical Device Regulation enters its second year of application, and the UK gears up for its own new regulations, manufacturers need to adapt their strategies to mitigate their risks.
In this webinar Peter Rudd-Clarke, Anna Lundy and Stefanie Lo covered: learning lessons from recent high profile life sciences litigation; capitalising on new laws and regulations to launch innovative products whilst reducing legal risks; and negotiating with your supply chain to allocate liability and regulatory risks.
The future of healthcare regulation in the UK: what you need to know
With the NHS in crisis and a transformation in the Care Quality Commission's (CQC's) regulatory approach, major changes are coming to the way that the safety and quality of health and social care is regulated. Reshma Adkin and Alice Babington shared their tips on how this will affect businesses in 2023.
The personalisation of life sciences and wellness products: UK and EU perspectives
Wearables and software are changing healthcare in significant ways by harnessing technology to provide individuals with a more personalised experience. The impact of these products covers a spectrum from consumer products aimed at the wellness market, through to devices used by clinicians and patients working in tandem to achieve early diagnosis and create bespoke treatment plans.
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