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Advertising UK The Prescription Medicines Code of Practice Authority (PMCPA) has published sanctions against five companies for bringing discredit upon the pharmaceutical industry. The cases include AUTH/3525/6/21 – Complainant v Novo Nordisk , AUTH/3542/7/21 – Complainant v Daiichi – Sankyo , AUTH/3550/7/21 – Health professional v Lundbeck , AUTH/3554/8/21 – Anonymous, non-contactable complainant v UCB […]

Advertising EU The Advocate General (AG) Szuphar has delivered his opinion whether discount campaigns regarding prescription only medicines run by mail order pharmacies fall within the definition of advertising. The AG’s opinion is that the purpose of the discount campaign is not to encourage patients to purchase medicinal products, but rather to attract them to […]

Advertising UK The Prescription Medicines Code of Practice Authority (PMCPA) has published new guidance for promotional material within the context of the Windsor Framework. See Guidance for further information. The Medicines and Healthcare products Regulatory Agency (MHRA) has also published its own MHRA guidance providing information on the implementation of changes to advertising and promotion […]

Artificial Intelligence UK The National Institute for Health and Care Excellence (NICE) has published a draft guidance document for consultation on the use of Artificial Intelligence (AI) technologies to help professionals detect fractures in urgent care settings. For further information and the draft consultation document see here Clinical Trials EU The European Federation of Pharmaceutical […]

Anti-microbial Resistance UK The Association of the Bristish Pharmaceutical Industry (ABPI) has set out its response to the United Nations General Assembly political declaration on antimicrobial resistance. See ABPI response here Artificial Intelligence EU The European Medicines Agency (EMA) has now adopted its reflection paper on artificial intelligence (AI) following its consultation and months of […]

Navigating and Managing Your In-House Legal Career in Life Sciences: Insights from Industry Experts  In our latest LawCast, Life Science Law explored some essential guidance to those looking to build and thrive as an in-house lawyer or compliance professional within the life sciences industry. Hosted by Wendy Lloyd-Goodwin, founder of Life Science Law, and joined […]

Solution LS Law worked closely with the company’s CEO and CFO to thoroughly understand the project’s expectations, services to be delivered, costs, timelines, and ownership of intellectual property. LS Law then reviewed and updated the software and development agreement, ensuring all critical commercial and legal points were addressed. Key Actions: Comprehensive Review: Assessed the terms […]

Solution LS Law collaborated with the company’s Managing Director to thoroughly review communications between them and their client regarding the dispute. LS Law assessed the claims made against the terms of the contract, provided strategic advice on the clients position, and crafted a firm yet fair response to their client’s allegations. Key Actions: Comprehensive Review: […]

Solution LS Law collaborated closely with the CEO and Chief Medical Officer of Sapient Therapeutics to draft and negotiate the necessary agreements with in-house legal counsel in Canada. The key agreements included a Technology Licence and Services and Equipment Supply agreement, and a Collaboration and Research Agreement with a leading academic institution. Key Actions: Technology […]

Solution LS Law stepped in to create a suite of template agreements tailored to Swarm Oncology’s needs. These included Confidentiality Agreements, Master Service Agreements, Consultancy Agreements, Licensing Agreements, and Material Transfer Agreements.  Additionally, LS Law provided support in negotiating Swarm Oncology’s first Collaborative Research and Development Agreement with a leading academic institution, along with a […]

Solution LS Law was engaged to provide an outsourced legal function to the UK arm of the Company, offering a range of ad-hoc legal services. This includes support for the development of Apps, distribution arrangements, joint working, and development and partnership arrangements with third parties, including the NHS. LS Law’s approach ensures their commercial needs […]

Solution LS Law provided expert legal support to help 3BP understand its responsibilities as a data controller of personal data. By collaborating with LS Law, 3BP addressed unknown areas in data privacy legislation, implemented best practices for data compliance, and established a data privacy by design roadmap. Key Actions: Legal Advice: Provided comprehensive guidance on […]

Solution Ingo Health appointed LS Law as their legal partner of choice due to LS Law’s deep understanding of life science law and their transparent pricing structure. LS Law provided optimum value for the future lifecycle of the business, ensuring all legal aspects were addressed from the start. Key Actions: Comprehensive Legal Policies: Created privacy […]

Artificial Intelligence  EU  The European Parliamentary Research Service (EPRS) has published a proposal for a directive on adapting non-contractual civil liability rules to artificial intelligence (AI). See the directive proposal here  Netherlands  The Dutch data protection authority has called for feedback on manipulative and exploitative AI systems under the AI Act. See here for further […]

Artificial Intelligence EU The European Medicines Agency (EMA) has published its guiding principles for how the industry should use large language models (LLMs) in a safe, responsible and effective manner. See EMA press release with guiding principles for further information. EU/UK The EU, United Kingdom and US have signed a new legally binding international treaty […]

In the latest episode of the podcast Mastering the Clock, Wendy Lloyd-Goodwin, Founder and CEO of LS Law, shares her deeply personal journey of balancing the demands of a legal career with the responsibilities of being a single parent. Her story is one of resilience, determination, and the ongoing challenge of mastering time management—a skill […]

Advertising  UK  The Medicines and Healthcare products Regulatory Agency (MHRA) has published four decisions following investigations into complaints about advertising for licensed products. See here for the published decisions.  Competition Law  UK  In connection with its investigation into the anticipated acquisition by Theramex HQ UK Limited of the European Rights to Viatris’ Femoston and Duphaston […]

In this article we once again focus on artificial intelligence, but this time looking at some of the key data privacy issues arising with the use of AI tools and what in-house lawyers need to consider to ensure data protection compliance.  The EU AI Act, which came into force on 1st August 2024, is essentially […]

Competition Law UK The Competition and Markets Authority (CMA) is reviewing the Assimilated Technology Transfer Block Exemption Regulation (Assimilated TTBER) to inform the CMA’s recommendation to government on whether to replace the Assimilated TTBER on its expiry on 30 April 2026. The consultation is open until 6th September 2024. Further details of the review and […]

Solution LS Law worked closely with the company’s CEO and CFO to thoroughly understand the project’s expectations, services to be delivered, costs, timelines, and ownership of intellectual property. LS Law then reviewed and updated the software and development agreement, ensuring all critical commercial and legal points were addressed. Key Actions: Comprehensive Review: Assessed the terms […]

Artificial Intelligence  EU  The European Data Protection Board (EDPB) has adopted a statement on the Data Protection Authorities’ (DPAs) role in the Artificial Intelligence Act (AI Act) framework. See statement 3/2024 for further information.  France  The French data protection authority, CNIL has published a series of frequently asked questions (FAQs) on the deployment of generative […]

Access to Medicines  France The French Haute Autorité de Santé (HAS) has announced that it will review the basis for evaluating applications for early access to innovative drugs with its work expected to be completed early in 2025. The review will consider the minimum data requirements for early access to ensure informed decision making, patient […]

Solution LS Law collaborated closely with the Global Compliance Officer to provide a tailored compliance function across the region. This was achieved by deploying industry-experienced compliance consultants in each country. These local consultants were able to start quickly and effectively, ensuring that compliance measures were in place within weeks. Key Actions: Deployment of Local Compliance […]

Solution LS Law provided a team of  legal and compliance secondees to support the international legal teams of the client and the JV new entity. This included identifying supply chain and other contracts, reviewing and renegotiating key agreements to ensure alignment with the new business needs. The work involved negotiation, drafting, and execution of novation […]

From the title of this article, I am sure you have already answered the question raised at the beginning “Burn Out, Are You There Yet?”. Our answers may vary—some of you probably silently screamed “yes!” while others have had to leave positions due to stress. Perhaps you are aware of people struggling around you, or […]

Access to Medicines UK National Institute for Health and Care Excellence (NICE) has approved access to cystic fibrosis modulator drugs Kaftrio, Symkevi and Orkambi, following the conclusion of a commercial agreement between the NHS and the pharmaceutical company Vertex. See NICE positive recommendation .   NICE has recommended CSL Behring’s Hemgenix (etranacogene dezaparvovec) as the […]

Here at LS Law, we continue to be immersed in looking at the impact of AI on our life sciences sector and we recently held a lively discussion forum with our consultants to explore the key risk factors of AI in life sciences organisations and the practical steps needed to manage those risks. What came […]

Access to Medicines EU The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published three reports, which show the inequalities in the time it takes for European patients to access medicines. The reports highlight that patients in one European country can wait more than six times as long as patients in another country for […]

Antimicrobial Resistance UK The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new team to support the international community tackle antimicrobial resistance and has pledged funding of £85 million to support the international community. See here for further information. International IFPMA has published a new report reviewing antibiotic pipeline data against bacterial pathogens […]

Artificial Intelligence  UK  The Medicines and Healthcare products Regulatory Agency (MHRA) has launched an AI Airlock, its new regulatory sandbox for AI as a medical device, to address challenges for regulating standalone AI medical devices. For further information see MHRA press release. For information on how to get involved in the AI Airlock see here […]

The EU AI Act and its Impact on the Medicinal Product Lifecycle  The EU’s AI Act received much fanfare when it was adopted earlier this year as it heralded the first comprehensive legislation to regulate artificial intelligence (AI) anywhere in the World. Whilst the Act itself is a done deal, the focus now turns to […]

Artificial Intelligence EU  EFPIA has issued a statement on the use of artificial intelligence (AI) in the medicinal product lifecycle in the context of the AI Act and has stated that it considers the exemption (under Recital 25, Articles 2.6 and 2.8 of the AI Act) applies to AI-based drug development tools used in the […]

The Medicines & Healthcare products Regulatory Agency (MHRA) has issued new Guidance on parallel import licencing across the UK to address the change to the special situation of Northern Ireland after implementation of the Windsor Framework on 1 January 2025. The Windsor Framework is the post-Brexit legal agreement between the European Union and the United […]

In January the UK’s Medical and Healthcare Products Regulatory Agency (MHRA) published its Roadmap, setting out the proposed timetable for the future regulatory framework for medical devices. The Roadmap sets out a phased approach for the introduction of the new regime over the next few years, introduced through four Statutory Instruments, with legislation on post […]

Artificial Intelligence   EU The Corrigendum of the EU AI Act has now been released. The document corrects and clarifies the text and is required before the Act comes into effect. See the corrected text here France The French data protection authority, CNIL, has issued its recommendations for using artificial intelligence technologies whilst protecting personal data. See CNIL recommendations […]

Artificial Intelligence EU On 13th March the European Parliament approved the text of the EU AI Act. Once the Council has signed off the text (expected later this month), it will be published in the Official Journal and will enter into force 20 days after publication. Please see adopted text of the AI Act here   […]

Artificial Intelligence EU AI Act final vote due to take place on 13th March. See press release. UK The Information Commissioner’s Office has opened a second call for evidence on generative AI. The consultation is open until 12th April 2024. For further information see here. Competition Law UK The CMA is to appeal the Competition Appeals Tribunal’s decision in the hydrocortisone […]

EU AI Act – Current Status As mentioned, EU member states voted unanimously to adopt the text of the AI Act on 2nd February, despite several indicating earlier opposition to the proposed text. There are still some additional steps to be completed before the EU AI Act can become law, including votes by The European […]

Artificial Intelligence EU On 2nd February EU Member states voted unanimously to adopt the text of the proposed AI Act. There are still some additional steps to be completed before the EU AI Act can become law, including votes by The European Parliament’s Internal Market and Civil Liberties Committees on 13th February, followed by a plenary vote scheduled […]

Headlines like these make the entire pharmaceutical industry hold its breath. The industry of manufacturing and selling drugs is rightly heavily regulated and whilst this can make it challenging to market and sell a medicine, there are very serious consequences for getting it wrong, as evidenced by the headlines above. Regulation and Industry Codes of […]

Deal-making The current financial environment is challenging and unlikely to change dramatically in coming months, suggesting that predictions for deal activity in general are likely to be somewhat mixed. Whilst inflationary pressures and an uncertain economic outlook have been real challenges to the financing of acquisitions, some commentators suggest these factors may be stabilising and […]

Post-Market Surveillance (PMS) Requirements As part of its priority to improve patient safety, the government intends to introduce legislation late in 2024 (with accompanying guidance) to strengthen post-market surveillance requirements. The proposed legislation will be laid before Parliament early in 2024. Proposed legislative changes seen in the draft Statutory Instrument included: Details of what must […]

Artificial Intelligence  EU  The EMA and Heads of Medicines Agencies have published a workplan to guide the use of AI in medicines regulation. The workplan focuses on four key area: i) Guidance, policy and product support; ii) AI tools and technology; iii) Collaboration and training and iv) Experimentation. The EMA announcement and Workplan are available here   Borderline […]

    In setting out its proposed update, the ABPI is aiming to ensure the Code remains fit for purpose and supports clear and robust standards. Whilst many of the proposed amendments are relatively minor or clarificatory in nature, there are a number of proposed changes which are clearly aimed at tightening governance and addressing […]

Artificial Intelligence EU Proposed new AI Act deal has been agreed upon by EU lawmakers – the text has yet to be published, but statements issued by The Parliament and Council provide some insight into agreed provisions. Consultation on the reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle due […]

1. Distribution – EU The Court of Justice of the European Union has confirmed that wholesale distributors must obtain their supplies of medicines only from persons who themselves are in possession of a wholesale distribution licence or are exempt from obtaining such a license and that Article 80 does not provide for any exception for pharmacies. Similar restrictions are […]

The scheme is currently in a pilot phase and is open to manufacturers seeking to develop and commercialise an innovative device in the UK. The application period runs from 25th September until 29th October 2023 and will be limited to up to eight devices. Successful applicants, who meet the eligibility and innovation criteria, will receive […]

How does the UK-US Data Bridge work? After the Schrems II ruling in 2020, it has remained unclear how companies could transfer data compliantly to the US. The EU-US Data Framework, which came into force in July 2023, did not cover the UK, following Brexit and transfers of data, which were subject to UK GDPR, […]

Navigating Regulations and Guidelines It is illegal to promote a POM to the general public, and so the careful use of social media platforms, by pharmaceutical companies and their employees is crucial. However, given the myriad of different ways we interact on social media, this can be tricky to navigate. The Prescription Medicines Code of […]

This comprehensive strategy is designed to create a resilient, future-proof regulatory framework that aligns with the evolving needs of health systems, focusing on promoting research and technologies to meet patients’ therapeutic requirements and addressing market failures and sustainability.    Key Measures  So, what are the most significant measures coming out of the new proposals?   Perhaps […]

Firstly, let’s look at the types of services typically purchased by the pharma industry from HCPs and HCOs. Examples include clinical trials, speaker arrangements, meeting chairing, insights collecting activities such as advisory boards and market research, providing services in the context of patient support programs, preceptorships, among others.  In the majority of cases we’ve listed, […]

Accuracy An AI language processing tool is trained form information inputted into it.  This means that when the algorithm was created, the decisions made by the creators about where the training information is sourced is critical to the output of information a user receives.  Some AI tools are not currently capable of providing of the […]

Discovery Our understanding of genomics is relatively new. DNA discovery only occurred in the 1950’s and the mapping of the genome was officially sequenced in April 2003. We are still building on the genomic foundations that will dictate the prognosis of the disease and responsiveness to treatments. The 100,000 Genomes Project launched in Britain in […]

Improving Contract Analysis AI has the potential to improve contract analysis. An advanced language model could be used to generate “boiler plate” language, allowing attorneys to focus on the substantive parts of the contract which reflects the deal, and risks are effectively covered.   Generative AI can boost efficiency and minimise the chance of errors and […]

The Payment Percentage in 2023, the final year of the current scheme, requires companies to pay 26.5% of sales revenue of branded medicines to the NHS. This rate is nearly three times what was originally anticipated and is outside historical norms. The rebate percentage is harming UK innovation by reducing the UKs desirability for investment […]

Both (AI) and (ML) have the potential to enhance our understanding of data and therefore our ability to accurately diagnose and treat patients. With the sheer volume of data generated in life sciences, advanced data analytics is becoming essential to efficiently discover valuable patterns by analysing large amounts of unstructured, heterogeneous, non-standard, and incomplete healthcare data. […]

What is the Voluntary Scheme? VPAS is a voluntary agreement between the UK government, NHS National Health Service (NHS) England and the Association of the British Pharmaceutical Industry (ABPI). The existing voluntary scheme expires at the end on 31 December 2023, with a new scheme scheduled to take effect from 1 January 2024. VPAS sets a […]

The first we are going to look at is Personalised Medicine Personalised medicine, sometimes referred to as precision medicine is becoming a new frontier in today’s healthcare. It is the process of tailoring therapeutics to an individual person. The basis for personalised medicine is understanding the role our DNA plays in health and medical conditions. […]

The History of Upfront Payments Historically the concept of upfront payments emerged to establish trust and mitigate risks in business transactions. It was also used to secure goods or services in advance. In the modern world it became even more essential as it provides businesses with necessary capital to initiate production of goods and delivery […]

What Does the Reform Look Like in Practice? The reform includes two legislative proposals: a new Directive and a new Regulation which constitute the EU regulatory framework for all medicines (including those for rare diseases and for children), simplifying and replacing the previous pharmaceuticals legislation. The Directive contains all the requirements for authorisation, monitoring, labelling […]

The Challenge of Data Collection Another vital challenge with outcomes-based pricing is reliable data collection. To measure outcomes accurately, it is essential to collect data not only during the clinical trial phase but also during the post-approval phase. This data collection requires significant investments in infrastructure, technology, and personnel, which can be challenging for smaller […]

The Pricing of Outcome-Based Medicines Outcomes-based pricing is usually based on the effectiveness of the drug in treating a specific set of symptoms. The pricing strategy ensures that payors are charged only for the duration of the therapy that is needed to achieve the desired results. However, this pricing strategy will require data to support […]

Areas of Expertise Catherine’s areas of expertise include: EU and UK Regulatory Affairs for various types of CBD/cannabinoids and medicinal cannabis, food supplements and novel foods, residues of THC in foods/food supplements, CBD in cosmetics and market entry opportunities.   Catherine was one of the early pioneers of the hemp cannabinoid industry and has experience in […]

For a law firm to achieve such an award is innovation itself. Innovation is not something lawyers or law firms are known for but we are doing it. It made us so proud to hear the host introducing the award as being given to people who had disrupted the markets in which they are operating […]

What Do the Guidelines Cover? The PMCPA Social Media Guidance 2023 covers companies’ use of corporate social media channels and employees’ personal use of those channels. In particular, it reminds companies of the relevant laws and Code provisions that apply in different cases within the UK, and the principles companies need to be mindful of […]

Wendy Lloyd-Goodwin – Founder – Life Science Law  “I am passionate about what I do.  I find working within the legal sector, finding solutions based on data and using legally defined parameters/ interpreting those parameters, and moulding the scope to fit within the legally defined parameters l framework to achieve a desired outcome extremely rewarding. […]

Pharmacovigilance The industry should take a proactive approach rather than just a reactive approach to social media. *Pharma companies should implement policies and/or procedures on social media platforms to ensure that they meet their pharmacovigilance responsibilities. *If the company (or an individual or third party on its behalf) becomes aware of an adverse event associated […]

Business fluent in English and Spanish, Fabrina has developed a deep understanding of international law and specialises in the pharma and medical devices world. Working with LS law clients Fabrina will offer expertise on commercial business processes and contract negotiations with knowledge and understanding of putting together commercial deals and partnerships. Fabrina’s experience reflects her […]

Education During my Medical Science degree, I was inspired to explore the intersection between law and medicine. My dissertation delved into ground-breaking research for potential treatments of Triple Negative Breast Cancer using Rho GTPase inhibitors. Further inspiring me were courses on human technology assessment, where I gained an appreciation for legal strategies behind drug development, […]

The Evolution of Decentralised Clinical Trials The COVID-19 pandemic highlighted the importance and usefulness of digital tools and decentralised procedures in a healthcare setting and in clinical trials. The above context and trend highlighted the need to provide further recommendations on the introduction of decentralised elements in the conduct of clinical trials in the EU/EEA, […]

We Know You’re Passionate About Whistleblower Legislation, Why Do You Think That it’s so Important in Today’s Business Climate? Although the term whistleblower is well known in the business world the new regulations and how companies need to conduct themselves is relatively new. Having spoken about fatigued compliance officers and under-resourced management teams, managing the […]

Virtual Clinical Trials The digital transformation of clinical trials and research is accelerating rapidly and offers sponsors numerous advantages from efficiency and cost effectiveness to improved patient compliance and datasets that capture a broader population. And in 2023 it will accelerate further.  While virtual clinical trials were being explored long before the pandemic, they have […]

International Transfer of Personal Data Another key challenge is for those businesses wishing to operate outside of the UK. Under the new proposals, organisations would be able to take a risk-based approach to assessing the impact of transferring personal data internationally using standard contractual clauses. This change could present a real risk to the free […]

How to Manage High Pressure Environments in the Workplace Managing client expectations is key in such high pressure environments and a skill I have learnt over the years. Often unrealistic deadlines are provided by business stakeholders, particularly where it is perceived that legal frameworks are slow and will take a long time to turn around. […]

Year-End Burnout I’m very aware that the conclusion of any period is when we very often must work hardest to ensure we achieve our goals. Throw into the mix the personal and professional pressures of getting everything finished by a terminal deadline like the festive period, pushes people to their limits. Likening the end of […]

How the Pet Passport Law has Changed Traveling abroad to EU countries and Northern Ireland (NI) with your pet cat, ferret or dog changed on 1 January 2021. Any pet passports issued in Great Britain, including the Channel Islands and Isle of Man, are now invalid for travel to an EU country or NI.  When […]

Veeva Systems recently carried out its Digital Clinical Trials Survey report which found that 87% of companies are now using decentralised technology up from 59% pre-pandemic. Companies have added an average of four new applications to their clinical landscape since the start of the pandemic leading to increased challenges with fragmented systems and processes. The […]

2. Considering Cultural Fit Finding a good cultural fit is often a big part of the puzzle. Cultural fit is about having employees whose beliefs , values and behaviours are in alignment with those of the employer. This can have its complexities but essentially by getting to know the client and the consultant we are […]

Precision Medicine For big pharma companies to get ahead they need to start adopting precision medicine. Precision medicine considers a person’s genes, environment and lifestyle to predict which treatment will be most effective. The defining feature of this practice of medicine is the focus on genomic data to design the specific treatment paths, this is […]

Results Following advice from LS Law, the organisation clearly understood its responsibilities as a data controller of personal data. By working with LS Law, the team at 3BP was able to constructively address any unknown areas in data privacy legislation and best practices of data compliance, and to put in place a data privacy by […]

Solution Ingo Health appointed Life Science Law (LS Law) as its legal partner of choice. Key to this decision was LS Law’s deep understanding of the needs of Ingo health and the business’ life science law experience which provided optimum value for the future lifecycle of the business. LS Law’s open and transparent pricing structure […]

Benefits of EU-CTR for Sponsors One Application The Regulation enables sponsors to submit one online application via the CTIS for approval to run a clinical trial in several European countries, making it more efficient to carry out such multinational trials.  Efficiency The Regulation makes it more efficient for EU Member States to evaluate and authorise […]

The Benefits of a Truly Global Reach When an organisation talks about having a ‘global reach’ it immediately conjures up thoughts of a large multinational with a widespread organigram and complex international corporate structure. This in many cases reflects the size and complexity of several clients we work with within the pharmaceutical sector. By comparison, […]

Data Rights Conflicts in Clinical Trials A notable aspect of the Code is that it addresses the existing issue of the conflict between data rights and study reliability in the industry which arises in circumstances where a participant seeks to withdraw from a clinical trial part way through a study. In such circumstances, the particular […]

Manufacturer Requirements for Marketing a Medical Device Under the UK MDR 2002 section 2, a manufacturer is defined as whether you manufacture a medical device by yourself or are outsourcing it to third parties, this would be deemed that you are the manufacturer under the regulation. Before placing any medical device, including in vitro diagnostic […]

Leading companies are increasing their adoption of high-end independent talent to fill the widening skills gap, remain agile in a still turbulent environment and access top professionals.  Companies are also benefiting from both the agility and flexible nature of outsourcing skills and talent but also seeing gains from the expertise and knowledge of specialist independent advice.  […]

Life Science Law’s Vision The vision was to provide a second to none service that could be turned on and off or up and down as required. The job market and the skills gaps that are appearing across most companies’ legal organograms would benefit from such a model. We have seen a hike in clients […]

LS Law’s Steven Dunkerley & His Career in the Life Sciences Industry What Attracted You to LS Law? I have been fortunate to have worked with Wendy before and was attracted by her personable and pragmatic approach and her outlook for LS Law, and the rapid growth it is experiencing.  What’s Been Your Experience of […]

LS Law’s Juliana Ospina Gonzalez & Her Career in the Life Sciences Industry What attracted you to LS Law? LS Law has a modern setup and is very forward-thinking. The focus of the business is on the client. Every client is treated uniquely and an individual plan is pulled together to fulfil each client’s business […]

LS Law’s Victoria Cartolano & Her Career in the Life Sciences Industry What Attracted You to LS Law? I think LS Law is quite unique, the company’s focus on the Life Science Industry was attractive to me along with the variety of projects I could get involved with. What’s Been Your Experience of Working at […]

David Williams & His Career in the Life Sciences Industry What Attracted You to LS Law? I was attracted by the opportunity to continue growing and developing as an experienced corporate commercial lawyer, with a focus on the life sciences industry.  I liked the idea of working independently but also being part of a team […]

Under the Presentational Limb, the Medicines and Healthcare products Regulatory Agency (MHRA) will consider the validity of assertions, characteristics and claims being made for it as a whole, and whether it is being presented as a medicinal product. Under the Functional Limb, the MHRA will consider its actual function and its intended use, and whether […]

After university, I temped as a legal coordinator for Bond Pearce within their insurance litigation department. I applied for training contracts across the UK. After almost two years, I was finally offered a training contract at Kidd Rapinet. I worked in their London and Maidenhead offices, specialising in property, private client, litigation and commercial, before […]

The cornerstone of the new ABPI Code of Practice is the concept of Collaborative working – which includes joint working, donations and grants, while breaking down the Medical and Educational Goods and Services (MEGS) umbrella into its constituent elements.  Collaborative working is when the industry works with the system to relieve it and provide other […]

Given the value of an organisations data,  it is important that that Data is treated just like it would any other valuable business asset (eg intellectual property rights, cash in the bank, etc.) and put in place suitable security measures to protect that Data. The fact that Data Security Incidents are on the rise in the UK […]

A medical device doesn’t achieve its intended action by pharmacological, immunological, or metabolic means, but does include devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to […]

BREXIT Trade mark protection will continue to apply in the UK for EU trade marks registered before 31.12.20 but for new trade marks, a UK trade mark must be filed with in the UK IPO to obtain UK protection and an EU application for EU protection(1). Please note, this article doesn’t constitute legal advice. For […]

When naming medicinal products the MHRA will ensure:No confusion with the name of another medicinal product No misleading therapeutic and/or pharmaceutical connotations No misleading impressions as to the composition of the product No phonetics/difficulties in its pronunciation are considered Numbers are avoided, to reduce confusion with its strength It doesn’t convey a promotional message regarding […]

Phase I This phase involves a trial of the drug in a small group of people, who are usually healthy volunteers. The main objectives of this stage are to discover a safe dose of the drug and understand how it affects the human body, including any side effects. The researchers will also consider the best […]

What’s changed? Post 1 January 2021, if a UK company wishes to obtain a MA that allows a medicinal product to be placed on the market in the UK and EU, they must make an application to the EMA as well as the MHRA. Whilst this doubles the paperwork, at present, the MA standards and […]

Under the Presentational Limb, the Medicines and Healthcare products Regulatory Agency (MHRA)  will consider the validity of assertions, characteristics and claims being made for it as a whole, and whether it is being presented as a medicinal product. Under the Functional Limb, the MHRA will consider its actual function and its intended use, and whether […]

So what have we been doing? Progressing the business plan for the Solicitors Regulatory Authority authorisation application. Its still not finished, but at every review, more items which were planned have been executed; Embedding a client management system; Shooting a video which provides an insight into Life Science Law’s value proposition; Taking on a number […]

• GB EORI number – needed to move goods to or from the UK. Check your EORI number. Apply for a new one if yours does not start with GB. • EU EORI number – needed If undertaking EU customs processes. •CONTROLLED GOODS – if importing controlled goods into the UK complete full customs declarations. […]

Distribution Agreements Pharmaceutical manufacturers can sell medicines to distribution companies who market the product themselves and profit from the sale to end customers. Like any commercial contract, distribution agreements have a large scope of terms. Examples of such provisions include minimum purchase requirements, maximum purchase quantities, restrictions on selling competing products, limitation of liability, and […]

As the week unfolded, there were a number of other areas where the cross-border experience was far from clear: Haulier not accepting parcels into Northern Ireland and Europe – Commodity Code and EU EORI number issue. Confusion on EU EORI numbers and whether shipping DDP was now possible into EU. Confusion on shipping directly to […]

So What is the Legal Team Doing in Terms of Setting its Focus in the Meantime? In our last article, we asked some questions as to what BREXIT means for cross border deals and agreements. Has the legal team got a handle on which cross border supply agreements will need to be reviewed? Some questions […]

What bearing does this have on existing cross-border contracts, supply chain, manufacturing, and trade agreements generally? How will this affect the way in which you negotiate new deals and promote your services? There are specific provisions governing healthcare, pharmaceuticals, animal health and professional services. Watch this space for further updates relevant to the Lifesciences industry […]