All Insights

Approval of insomnia app for use in the NHS offers a case study for digital health developers

Fri, 27 May 2022 09:50:44 +0100

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Opportunities are available for those that navigate the regulatory system and provide evidence of their products' efficacy and performance

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Medical device, clinical trial and safety rules reforms could boost UK life sciences

Thu, 19 May 2022 11:48:18 +0100

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As the economy falters and NHS waiting lists grow, 2021 legislation offers wide powers to reform product rules and spur innovation

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New WTO Covid-19 vaccine IP waiver proposed

Thu, 12 May 2022 11:56:20 +0100

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A new vaccine IP waiver proposal has been published by the WTO Director-General following informal negotiations between the EU, India, South Africa and the USA

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Italy is finally poised to get a law on transparency in the healthcare sector

Thu, 07 Apr 2022 08:57:54 +0100

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Sunshine Act will oblige Italian pharmas to respect the obligations of transparency regardless of industry codes

The Italian Parliament is currently debating a bill regarding the transparency of relations between manufacturing companies, subjects operating in the health sector and health organisations which will be known as the Sunshine Act.

Italy is, therefore, close to adopting primary legislation aimed at strengthening transparency in the relationships between manufacturing companies and the main players in the Italian health system.

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Digital Regulation Cooperation Forum launches a UK hub for expertise

Wed, 06 Apr 2022 16:11:58 +0100

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A network of UK regulators' research portal will bring together work on the regulation of digital markets and is likely to be of interest to businesses that operate digitally

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The transfer of Data of non-profit clinical trials to pharmaceutical companies is now allowed in Italy

Tue, 05 Apr 2022 09:07:02 +0100

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Previous restrictions on data transfer are lifted, enabling more investment - some clarification on practical issues is awaited

In the framework of the Italian reform on clinical trials, a new decree of the Ministry of Health came into force on 3 March 2022 in order "to facilitate and support the implementation of non-profit clinical trials of medicinal products and observational studies, as well as to regulate the transfer of data and results of non-profit trials for registration purposes" (decree dated 30 November 2021, published on the Official Gazette on 19 February 2022).

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Compassionate Use in Europe

Mon, 04 Apr 2022 10:37:51 +0100

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As European countries implement compassionate use programmes in different ways, we offer a guide to the different approaches taken within the EU and in the UK

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European Commission proposes harmonisation of patent law with unitary SPCs and single procedure for grant

Fri, 18 Mar 2022 10:40:08 +0000

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The European Commission has launched a call for evidence on its proposal to create a unitary supplementary protection certificate and/or a single procedure for granting them

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Farmindustria releases updated Code Of Ethics

Wed, 02 Mar 2022 08:13:57 +0000

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Italy's association for pharmaceutical companies has amended its Code of Ethics with 4 new articles on PSP and on the promotion of medicines.

The Board of Farmindustria, the Italian Pharmaceutical Companies Association, recently approved amendments to its code of conduct that are of interest in connection with information and promotion activities concerning therapies.

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Is Italy's new law on rare diseases a starting or end point?

Mon, 28 Feb 2022 09:21:42 +0000

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Pharmaceutical companies will need to take note of new rules that include funding for research and tax incentives

After a discussion lasting more than three years in the halls of the Italian Parliament, the first Italian law on rare diseases was approved and came into force on 12 December 2021 (Law 10.11.2021 no. 175 - "Provisions for the treatment of rare diseases and for the support of research and production of orphan drugs").

The law can be considered as a consolidated act on rare diseases – these, until its entry into force, had been regulated through various ministerial decrees – containing measures aimed at standardising national health services in the supply of services and medicines, updating the LEAs (essential levels of assistance) and the list of rare diseases, strengthening the National Network for Rare Diseases, and regulating actions dedicated to supporting research on rare diseases and orphan drugs.

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2021 Life Sciences Patent Case Review

Tue, 01 Feb 2022 11:35:25 +0000

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The UK Patents court has had an active year – we review 18 of the principal cases for the sector

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Medical device advertising in Italy: is authorisation by the Ministry of Health still required?

Fri, 28 Jan 2022 15:59:56 +0000

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Italian Ministry of Health departs from harmonised EU regulatory framework on advertising medical devices by continuing authorisation regime

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2022 Finance Act increases State investment in Italian national health system

Tue, 25 Jan 2022 12:40:59 +0000

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Pharmaceutical spending ceilings are increased and reforms to technical standards are expected

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Global healthcare's embrace of patient support programmes spurs regulatory action

Thu, 20 Jan 2022 12:05:04 +0000

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Support programmes for patients are proliferating and regulators are looking to intervene in their international development

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Predictions 2022: What could be in store for US and international business?

Tue, 18 Jan 2022 09:24:46 +0000

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Businesses will be readying themselves for growth and transformation in a year in which the world hopes to move on from the pandemic

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LSPN Live | Strategies in Second Medical Use Cases

Wed, 22 Dec 2021 10:07:44 +0000

Are European advertising laws ready for patient support programmes?

Mon, 06 Dec 2021 17:58:27 +0000

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The legal situation in Europe regarding advertisement of PSPs is highly fragmented with different jurisdictions taking varying approaches to address upcoming problems

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Trade secrets remain the sticking point in global debate over a vaccine IP waiver

Fri, 03 Dec 2021 10:49:40 +0000

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A consensus on the vaccine IP waiver is yet to be reached, but will the cancellation of WTO's 12th Ministerial Conference cause even more delay?

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Dealing with healthcare data: an overview of the key European markets

Tue, 20 Jul 2021 18:09:18 +0100

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Hemp tea - the fine line between food and narcotics

Fri, 02 Jul 2021 13:37:52 +0100

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The first article from our series "Cannabis - the 'green gold' from a legal perspective"

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Debate intensifies over a vaccine IP waiver's impact on future pharma and biotech discoveries

Mon, 17 May 2021 15:42:38 +0100

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Does a proposed patent suspension backed by Washington open a Pandora's box for vaccine R&D and investment?

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Queen's Speech 2021 sets out ambitious agenda for UK life sciences and healthcare

Wed, 12 May 2021 17:40:59 +0100

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New parliamentary term will be packed with legislation for life sciences and healthcare businesses

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Patents Court upholds validity of second medical use patent for glaucoma treatment

Tue, 11 May 2021 16:29:55 +0100

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This decision shows the court assessing patentability in a real-world practical context, recognising the uncertainties of R&D that only later may appear to have been obvious

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Support programmes offer global healthcare ways to meet patients' needs

Mon, 10 May 2021 13:59:57 +0100

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With technological advances increasing access to patient support programmes, what legal and regulatory issues do pharmaceutical companies need to take into account when using these arrangements?

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UK government backs breakthrough tech with £375m future fund

Fri, 07 May 2021 17:44:44 +0100

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Successor to a coronavirus support scheme as well as a new sovereign investment partnership offer crucial access to capital for fast-growth life science, healthcare and innovative businesses

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