Healthcare
Leading life science organisations and emerging healthcare companies trust Linklaters lawyers to help navigate them through the myriad of challenges to achieve their goals in a highly regulated and rapidly changing healthcare industry
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After Lundbeck: Is the “pay for delay” debate over?
The wheels of justice may turn slowly, but their grind is relentless. In 2013, the European Commission fined Lundbeck and several generic pharma companies EUR 146 million in respect of anti-competitive agreements inked in 2002. That marked the Commission’s first enforcement action against pharma patent settlements. Nearly two decades after those agreements were concluded, the EU’s Court of Justice recently rejected the companies’ appeals against the Commission’s prohibition decision. A clean and clear vindication of the Commission’s approach.
Digital Health
Digital technology is revolutionising the healthcare industry. From robotic surgeons and wearable devices that measure and record vital signs, to smartphone Apps that detect diseases and new platforms for analysing medical data, things are changing fast.
The MDR is here Regulatory changes and their impact on liability
The MDR naturally brings with it a number of regulatory changes and challenges, but it also contains provisions that can be expected to have an impact on medical device liability under the Product Liability Directive and its national counterparts.
The European Commission struck down on pharma pricing. Shook Aspen - and the whole forest?
The Aspen case illustrates the political and competition agency profile in relation to pharmaceutical prices. The fact that the EC pursued this matter is significant, but it is acknowledged to be an unusual case. The EC’s settlement with Aspen reduced the price of certain cancer medicines by 70+ percent. But the role of enforcement agencies in tackling drug prices considered to be “excessive” remains uncertain.
Covid-19: Supplying vital medical equipment in uncertain times and managing regulatory, contractual and reputational risk
The spread of Covicd-19 has resulted in a sharp increase in demand for personal protective equipment (“PPE”), medical devices and Covid-related health technology products. Consequently, many companies – both within and outside the healthcare sector – are considering, and many for the first time, manufacturing products such as protective masks, ventilators and hand disinfectants.
Covid-19: Impact on EU Healthcare Regulation
The healthcare sector has been a key focus for many as a result of the Covid-19 pandemic. Global hopes for a cure - and for ways to mitigate the effects of the pandemic - are pinned on healthcare. Unsurprisingly, this has translated into significant investment in the healthcare sector - with digital health ventures alone receiving $8.26bn USD of investment by venture capital funds in the first half of 2020.
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After Lundbeck: Is the “pay for delay” debate over?
After Lundbeck: Is the “pay for delay” debate over?
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Digital Health
Digital Health
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MDR regulatory changes
MDR regulatory changes
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The EC decision on Aspen case
The EC decision on Aspen case
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Supplying vital medical equipment in uncertain times
Supplying vital medical equipment in uncertain times
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Covid-19: Impact on EU Healthcare Regulation
Covid-19: Impact on EU Healthcare Regulation
