13 Jun 2022 Summer of 2022; the dawn of the behemoth, Haleon plc By Robert Newman Think back almost four years to December 2018. A certain Donald Trump was POTUS, Theresa May survived a vote of no confidence (by a vote...
04 Apr 2022 MHRA announce new scheme for monitoring good manufacturing and distributions practices in IAG cases By Taryn Jones Teresa Hitchcock The Medicines & Healthcare products Regulatory Agency (MHRA) has announced a new supervisory scheme as part of its process for monitoring...
16 Mar 2022 UK ABPI calls for standardised international approach to university-industry collaborations By Richard Taylor Anna Wrench The Association of the British Pharmaceutical Industry (ABPI, the UK’s leading association for pharmaceutical companies), has published a...
18 Feb 2022 Clinical Trial Regulations in the EU – how will the UK follow? By Kate Burgess The European Medicines Agency has confirmed that the new Clinical Trials Regulation is now in effect as of 31 January 2022. Please see...
08 Feb 2022 An analysis of the effect of drug pricing provisions in the Build Back Better Act on pharmaceutical innovation By Kirsten Axelsen Having previously examined the impact of implementing international reference pricing in the United States, Charles River Associates (a...
17 Jan 2022 Legislative initiative on off-label prescription By Vadim Barbu Off-label use of medication is currently not regulated in Romania. Rather, it is up to the doctors to decide on the off-label use of a...
13 Dec 2021 Do medical devices have systematic bias? By Kate Burgess Anna Ward An investigation has been launched by the UK’s Department of Health and Social Care (“DHSC”) with the overall aim of improving healthcare...
17 Nov 2021 Assessing the value of medicine for diverse patients: Implications of a QALY approach for health disparities By Kirsten Axelsen Momentum and debate about the application of cost-effectiveness analysis to determine the value and prices of prescription drugs in the...
11 Nov 2021 The unhealthy healthcare system – a view on the treatment of medical waste By Inês Santana Metello Mariana Ricardo Countries and industries have been progressively setting ‘net zero’ targets, adapting legislation and activities to move towards a...
04 Oct 2021 Update: Poland - Plan for Rare Diseases for 2021-2023 By Amelia Prawda In the last week of September 2021, the Polish Cabinet finally published the Plan for Rare Diseases for...
13 Jul 2021 Use of preventive care services declined despite expanded coverage By Kirsten Axelsen Key Points: For the privately insured, Medicare, and uninsured populations, the prevalence of the use of preventive care services...
06 Jul 2021 Poland: A revolutionary draft amendment to the Reimbursement Act By Amelia Prawda Jolanta Dabrowicz Andrzej Balicki, Ph.D. On 30 June 2021, a draft bill amending the Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs for Special Nutritional...
19 May 2021 Telehealth services remain a focus for the Australian Government as funding is extended until the end of 2021 By Greg Bodulovic Stephanie Wang The Australian Federal Government has announced an extension of telehealth funding for general practitioners, allied health providers and...
28 Mar 2021 On the radar: negotiations on a legislative proposal concerning HTA to start By Mariana Ricardo Following the European Commission's (EC) adoption of a proposal for a Regulation on health technology assessment (HTA) in 2018, and the...
22 Mar 2021 The future regulation of medical devices in the UK under the Medicines and Medical Devices Act 2021 By Kate Burgess Anna Ward The Medicines and Medical Devices Act 2021 (the “MMD Act”) was granted royal assent on 11th February 2021. The MMD Act confers broad...
16 Mar 2021 Updated regulations in the Irish Pharma sector By Louise McErlean Caoimhe Clarkin The IPHA has updated its self-governance and advertising codes; key updates for those in the pharma sector.The Irish Pharmaceutical...