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In this issue: Advertising, marketing and sponsorship Agency and distribution Consumer protection Contracts E-commerce International Public procurement Supplier management LexTalk®Commercial: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Advertising, marketing and sponsorship ASA rulings—31 July 2024 The Advertising Standards Authority (ASA) has flagged the Person(s) unknown trading as Mendio Life for inquiry after insights from its Active Ad Monitoring system. A Meta promotion by Mendio Life for an acupressure clip asserted medical effects for a device lacking the necessary conformity marking and absent from the Medicines and Healthcare Products Regulatory Agency (MHRA) register. This decision sits within the ASA’s wider work on advertisements asserting treatment for prostrate issues, as part of a consumer-protection drive against such claims. The ASA also received a complaint about Nultqh GB’s Meta advert for a prostate patch, which advanced medicinal claims for an unlicensed item. The...
In this issue: Intellectual property Medical devices Pharmaceuticals—regulatory framework Borderline products Commercialisation Advertising of medicines LexTalk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Useful information Intellectual property Chris Weekes, Technical Assistant at D Young & Co, reviews a landmark ruling on infringement of a second medical use patent, indicating how the Unified Patent Court (UPC) may handle such claims. See News Analysis: First UPC infringement decision for second medical use claims. Medical devices MLex reports that the European Commission is weighing a delay to the EU AI Act entering into application amid disputes over a code of practice for AI models, mounting industry resistance, and slippage in drafting technical standards. The move, still unconfirmed, could pause enforcement timelines to allow targeted amendments aimed at simplifying specific elements. See News Analysis: EU Commission eyes pausing AI Act’s entry into application...
Pharmaceuticals—regulatory framework European Parliament adopts Critical Medicines Act proposal to address supply shortages The European Parliament has endorsed plans to bolster the availability and supply of essential medicines across the EU, approving the proposals by 503 votes in favour, 57 against and 108 abstentions. The package seeks to lessen the EU’s reliance on non‑EU countries and strengthen pharmaceutical competitiveness by backing strategic industrial projects to expand and modernise manufacturing capacity within the Union. Under the proposals, contracting authorities would be required to apply procurement criteria that favour manufacturers producing a significant share of critical medicines in the EU, with price no longer the sole determinant for contract awards. The measures also lower the bar for joint cross‑border procurement from nine to five countries and create an EU co‑ordination mechanism for national stockpiles of critical medicines, empowering the Commission, as a last resort during shortages, to reallocate medicines between Member States. Industry has reacted critically to the current text, warning that certain provisions could dilute the original intent of...
Successive UK governments have aimed to cement the UK as one of the world’s most appealing settings for innovation and enterprise. To that end, a wide-ranging suite of tax incentives has been rolled out to encourage innovative companies, supporting both investors and trading entities, and assisting businesses at every phase of a business’s life cycle. These incentives include: R&D tax reliefs patent box business asset disposal relief (previously entrepreneurs’ relief) capital allowances for purchases of: knowhow patents, and plant and machinery venture capital trusts the enterprise investment scheme, and the seed enterprise investment scheme This Practice Note outlines the UK position on key tax considerations when determining how to structure an innovative business with international or global aspirations. The observations are general in nature and work on the basis of a clean slate; revisiting an existing IP ownership arrangement will inevitably demand a bespoke solution (notably...
What is digital health? Digital health is a broad umbrella describing how information and communication technologies are used to enhance prevention, diagnosis, treatment, monitoring, and the management of health conditions and lifestyle habits that influence wellbeing. Its rise reflects the coming together of healthcare and technology, and a move away from provider‑focused, ‘one size fits all’ delivery towards personalised, patient‑centred care. This Practice Note explores data protection considerations across three digital health use cases: Wearables Use of artificial intelligence (AI) in medical diagnostics Digital health records Unlike mobile health (mHealth), which is limited to care delivered via mobile devices, digital health is wider in scope. It encompasses modern care models such as digital therapeutics, telemedicine, digitised health systems and electronic health records, as well as AI, machine learning and data analytics. For more on mHealth, see Practice Notes: Digital health—regulation of mHealth apps and medical software and mHealth—data protection considerations. Digital health solutions can be applied at every stage...
This Practice Note examines matters and recommended approaches for sharing personal data between controllers (including joint controllers and independent controllers) in general business-to-business commercial situations, under Regulation (EU) 2016/679, the EU’s General Data Protection Regulation (EU GDPR). It proceeds on the basis that readers already understand the main data protection notions and terminology, and the function of key supervisory organisations. For a broad overview of the EU GDPR and connected topics, see Practice Note: The EU’s General Data Protection Regulation (EU GDPR). In brief—summary of steps controllers should often take before data sharing The EU GDPR is designed to ensure information about living individuals (within the meaning of ‘personal data’) is handled fairly and responsibly. A central safeguard is the set of duties imposed on ‘controllers’—generally those determining why and how processing occurs. ‘Processing’ is widely construed to cover almost any operation on data, such as storing, deleting, collecting, disclosing or using it. In short, before commencing any routine controller-to-controller sharing, commercial organisations should usually: ...
This Deed is executed on [ insert date and month ] 20[ insert year ] Parties [ Insert name of first party ] of [ insert address of first party ] (referred to as AB: [ insert first and last name of first party ]) [ Insert name of second party ] of [ insert address of second party ] (referred to as BC: [ insert first and last name of second party ]) Recitals The parties intend that this Deed shall have binding legal effect upon them, together with their respective personal representatives and estates. [ Both parties acknowledge they have had the benefit of independent legal advice regarding the terms and effects of this Deed OR [ AB OR BC ] has obtained independent legal advice concerning the terms and effects of this Deed and [ BC OR AB ] has been advised to do so ] . Each party has agreed to this Deed...
GENERAL INFORMATION Client and spouse/civil or unmarried partner: names, address, landline, mobile, email, DOB, marital status... Children: names, DOB; previous marriages; ongoing financial commitments (details if yes)... Earlier Wills (with dates) or retrieve; LPAs/EPA (details or retrieve); other dependants... AML documents received and checks complete; note any capacity, health or duress concerns... ASSETS AND LIABILITIES Homes: description, £ value, ownership (joint tenants, tenants in common, or sole)... Other assets: cash, investments, shares, cryptocurrency/digital assets with £ values; foreign assets with location/type... Life and pension policies, in trust? provider and £; company interests... Valuable chattels; business/agricultural interests; trust interests/powers/inheritances with approx £... Lifetime gifts: details, £, donee, date; liabilities incl. mortgages, credit cards etc., with £... WILL DETAILS Mirror Wills; executors and relationship; guardians and relationship... Specific pecuniary legacies and tax status; trust legacies (e.g. business/agricultural property); other bequests; personal possessions letter of wishes (copy if available)... ...
Long residence and private life resources—overview The ten-year long residence route set out in the Immigration Rules, Part 7, does not allow dependants to submit applications alongside the principal applicant. This means joint filing is not available under this route. Dependants may, however, apply independently where they satisfy the criteria of the relevant rule. By way of illustration, if a husband and wife have each been lawfully present in the UK for ten continuous years, they must each file their own separate applications under the long residence provisions. See Immigration Rules, Part 7, para 276B–276C. When a Tier 2 (General) migrant secures indefinite leave to remain (ILR) through the long residence rules, their spouse may have scope to seek leave to remain as the spouse of a settled person under Immigration Rules, Appendix FM (see Practice Note: Partners applying for limited leave to remain under Appendix FM: eligibility tables)...