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 and regulatory protection, placing on the market and other regulatory procedures for all medicines authorised at EU and national level.

The Regulation sets specific rules (on top of the ones in the Directive) for medicines authorised at EU level, in particular the most innovative ones. It sets out the rules on coordinated management of critical shortages and security of supply of critical medicines. It also sets out the rules governing the European Medicines Agency (EMA).

The reform also includes a Council Recommendation on antimicrobial resistance (AMR).

Major Changes t0 the Legislation

Reduced Minimum Exclusivity

One major change included in the draft legislation is the reduction of the minimum period of regulatory protection for innovative medicines to eight years, down from 10 years under the existing legislation. Drugmakers can extend protection to a maximum of 12 years by: launching drugs in all member states; addressing unmet medical needs; running comparative clinical trials; and developing new therapeutic indications. The idea is to incentivize companies to reach more patients.

Accelerated Drug Approvals

Another change relates to drug approvals. The European Medicines Agency (EMA) will have 180 days to assess new medicines, down from 210 days, and the Commission will have 46 days to authorise drugs, down from 67 days as part of the proposals. The Commission sees the changes reducing the current average of around 400 days between submission and market authorisation.

Critical Medicines List

Finally, pharmaceutical companies will have to address critical shortages, and report on the results of the measures taken (such as the increase or reorganisation of manufacturing capacity or the adjustment of distribution to improve supply). In addition, an EU list of critical medicines – i.e. medicines considered to be most critical for health systems at all times – will be established.

The legislation will also allow the Commission to introduce, through an implementing act, measures to strengthen security of supply, including requirements to establish contingency stocks.

The Future

The pharmaceutical industry is a key sector for the EU’s economy.

In 2020, EU companies invested more than €26.5 billion in Research and Development (R&D) and they are responsible for around 840,000 direct jobs. The EU, UK and Switzerland are the second biggest R&D investors in pharmaceuticals (€39.7 billion in 2020) after the US, which has invested €63.5 billion in 2020 (EFPIA data).

In terms of manufacturing high-tech medicines, EU exports have increased from €50 billion in 2002 to €235 billion in 2021, while imports grew from €32 billion to €100 billion in the same period. The EU’s trade surplus in medicinal and pharmaceutical products reached €136 billion in 2021, the highest value on record (Eurostat).

The proposals will now be discussed by the Parliament and the Council.

This blog is a general summary of the law. It should not replace legal advice. If you require any further information contact us. 

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 or newer companies. Moreover, there is often a lag between data collection and the issuance of payment, which may cause cash flow issues for manufacturers.

The Challenge of Payer Engagement

For outcomes-based pricing to succeed, manufacturer-payor collaboration is critical. It is essential to establish clear agreements between the payor and the manufacturer regarding outcome measures, data collection, and pricing methodology. However, payors may be hesitant to adopt outcomes-based pricing due to concerns about administrative burdens, data access, and pricing transparency. Therefore, manufacturers must engage with payors early and transparently to ensure broad adoption of this pricing model.

The Challenge of Regulatory Expectations

Medicine Regulators, such as the US Federal Drug Administration (FDA), may have specific expectations for the clinical trial design and outcome measurement for products using outcomes-based pricing. For example, the FDA may ask for detailed plans for data collection and analysis before approving a clinical trial. This level of scrutiny can be challenging for manufacturers, who must balance the expectations of Regulators with the need to innovate new medicines to meet unmet medical needs.

The Challenge of Pricing Uncertainty

One of the primary challenges of outcomes-based pricing is the uncertainty regarding the ultimate price paid for the medicine. This pricing uncertainty can be challenging for manufacturers, who may have significant investments in research and development and are seeking a return on that investment. The uncertainty may also discourage new entrants to the market who are uncertain about the potential revenue for their product. Thus, it is essential to have clear and transparent pathways for price negotiation and to ensure that manufacturers are appropriately compensated for their products.

Whilst outcomes-based pricing would seem to be burdensome, if structured correctly, it is an innovative solution to the conundrum of pricing medicines that effectively reflect their value. While this pricing model has several challenges, including defining outcomes, data collection, payor engagement, pricing uncertainty, and regulatory expectations, these are surmountable with proper planning, collaboration, and stakeholder engagement. When implemented correctly, outcomes-based pricing holds the potential to revolutionise the way we price medicines, ensuring that patients receive access to the most effective treatment at an affordable price.

Our team of legal consultants are well versed in structuring outcomes based pricing models, and contract development, which are transferable into the commercial setting, ensuring the data collection burden is seamlessly integrated.

If you would like to discuss how we could help you, please do  book a no obligation meeting:

meeting booking or email us:  info@lslaw.mhwddev.co.uk

We would be delighted to support you.

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 its effectiveness, and could potentially add an additional burden on patients in terms of testing, doctor visits, and time, which could have an  effect on stress levels, and mental health disorders.

Advanced Therapy Medicinal Products (ATMPs)

ATMPs are a relatively new area of drug development, and their curative potential of ATMPs is changing the face of healthcare.  Whilst there is a potential long-term saving and quality of life, the immediate impact of the treatment can be intrusive and lead to significant disruption for not only the patient, but also the wider family of the patient, and may affect not only the mental well-being of the patient, and their family, but also a significant economic burden.  This, together with the high pricing of ATMPs is still a major barrier to access for most patients and healthcare providers to potentially curative treatments.  More consideration is needed in the development of these medicines to ascertain how mental well-being of the patient and their family along with the financial burden can be alleviated. 

The Role of Mental Health in Drug Pricing

Mental health and quality of life needs to play a more significant role in drug pricing to ensure that the quality of life of patients and the impact of treatment on their mental health receives the attention it deserves. Incorporating support packages for patients and their families into the pricing strategy could ultimately improve the quality of care patients receive, and a more desirable outcome for not only the patient, but the wider community. 

The Way Forward

To address the current situation, drug manufacturers, healthcare providers, and policymakers must work collaboratively to take into account the impact of treatments on the mental health and well-being of patients and the wider community. Innovative medicines require innovative ways to ensure not only the treatment is efficacious, but the treatment pathway does not have an unbalanced bearing on mental health.  There is increasingly more emphasis being placed on the need for patient support programmes, to accompany treatment regimes, and these support programmes also need to be factored into the pricing strategy adopted by NICE and other pricing agencies.

The pricing of medicines should be done with a view towards looking at the short term price, but also placing greater emphasis and value on the longer term reduction in costs, through potentially curative treatments, meaning less burden on the health service and improved mental well-being of patients receiving the care they deserve. 

Life Science Law has a team of experts who have a wealth of experience in the development of patient support programmes and pricing strategies and are well-placed to provide support in this area. If you would like to discuss how we could help you, please do book a no obligation meeting: 

meeting booking or email us:  info@lslaw.mhwddev.co.uk 

We would be delighted to support you.

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 product formulations and an in-depth knowledge of purchasing behaviour including key reasons  consumers buy CBD products. She believes that there is enormous scope for developing  OTC medications. 

Catherine also has knowledge of the UK medical cannabis prescription market and a sound overview of all the various EU Countries varying policies and availability of prescribed medicinal cannabis. She held various roles within the European Industrial Hemp Association (EIHA). EIHA defends and represents the interest of the entire hemp value chain, from seed to shelf. She represented the industry with UK Regulatory Agencies (FSA, MHRA) for six years. She has also experience of working with the UK Health Safety Executive and the Department of Business, Enterprise and Regulatory Reform. In her various roles as Board Member, Vice President and now member of the Advisory committee of EIHA she contributed in developing key policy documents and attended meetings at the EU Commission in Brussels with PAFF and SCOPAFF.  

Catherine is also a member of the novel food working group whose responsibility was to submit the novel food application for CBD isolate, full spectrum and synthetic CBD to both EFSA and the UK FSA. She also contributed to developing the clinical trial protocol for the largest ever study on the effect of THC in humans. 

Catherine says: “‘I’m delighted to join Life Sciences Law as a Regulatory Affairs consultant and look forward to contributing my experience and expertise in the CBD and medicinal cannabis sector to enable executives to decipher notoriously complex legislation and regulations which will in-turn help them to make informed decisions.” 

Life Science Law’s Founder, Wendy Lloyd Goodwin, adds: “We are really excited to have Catherine on board. The cannabinoid market is changing, and Catherine’s expertise and informed insights in this area are second to none.”   

In the coming months, we will be publishing some of Catherine’s insights into relevant areas of interest in the industry.

For more information on the legal implications of launching cannabinoids into the medical market, contact us today. Our team of experts can partner with you throughout your journey.

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 in a positive way. LS Law is making a mark in the world and our clients are loving the support we are providing to them.

Winning the award, got us all thinking about how we got to where we are. Having a growth mindset, thinking outside the box, having grit and determination and ultimately not giving up have been paramount. We’ve put together some tips on how to adopt a growth mindset and thoughts on what having one means to us. 

Many successful business owners and entrepreneurs have one thing in common, a growth mindset. A growth mindset is an attitude that allows you to think outside the box, show grit and determination, not give up when things get tough, focus on solutions over problems, and push yourself out of your comfort zone. Having a growth mindset not only helps you achieve success in business but also in life. 

Reframe your Thoughts

One of the most important elements of developing a growth mindset is reframing your thoughts. Instead of focusing on failure or negative outcomes, focus on what you can learn from each experience and how it can help you grow as an individual. Acknowledge that sometimes things don’t go as planned but recognise that there may be something valuable to gain from the experience. Reframing your thoughts will help you see the potential in every situation instead of dwelling on the negatives.  

Learn from Others

Surrounding yourself with people who have a growth mindset can be extremely beneficial in helping you develop one yourself. Connect with those who have achieved success by staying true to their values and pushing themselves beyond their comfort zone. Ask them questions about their experiences and take note of their advice so that you can apply it to your own life or business strategy. You’ll be surprised at how much knowledge they have gained through their successes, and failures, which could provide invaluable insight into how to achieve success yourself. 

Look for Opportunities to Grow

Developing a growth mindset means being open to new ideas, experiences, and changes in order to grow both personally and professionally. Look for opportunities to challenge yourself by taking risks or trying something new, this could involve taking on additional responsibilities at work or exploring unfamiliar territory within your industry or outside it altogether. Every opportunity should be viewed as an opportunity for learning which could lead to further personal development down the road. 

By having a growth mindset, you will be able to think outside the box, stay determined even when faced with adversity, focus on solutions rather than problems, and push yourself out of your comfort zone all while achieving success both personally and professionally. Developing this type of attitude takes time but if you are patient, persistent, open-minded, creative, and willing to learn from others then eventually you will reach your goals! 

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 when using or interacting with social media.

It also looks at the use of social media in specific situations, such as clinical trial recruitment, patient support, working with influencers, job advertising, and announcing product or pipeline milestones. 

Challenges of the Guidance

There are a series of challenges that need to be addressed with the guidelines. For example, particular difficulty arises where a communications team is based in the US and the campaign/audience is global in nature, and whilst it may be compliant to talk about product to the general public in the US, if the audience includes the UK, then it is foreseeable that there could be a UK Code breach for which the UK arm of the corporation will be culpable.   

Secondly, the guidance is the first codified parameter on how to use social media compliantly and is built from the myriad of cases which have been handled by the PMCPA. It is a helpful starting point, yet how the guidance is interpreted will still turn on subjective viewpoints which will cause angst within review teams. In these circumstances, the in-house lawyer is often required to provide an independent viewpoint between those of medical and marketing, which is balanced in terms of an interpretation of the regulations and risk.  

Finally, it is the medical signatories reputation on the line should they sign off materials which later lead to a hearing before the PMCPA. Given pharma companies need to take into account the actions of third parties over which they have no control, a conservative approach is often taken, which  in some cases  can cause unnecessary internal conflict between medical and marketing. While companies must and do provide internal guidance and training, to me it seems wholly unfair and doesn’t align with the way in which our legal system works to be responsible and culpable over actions which you have no control over, particularly where efforts have been taken to ensure the third party is aware of the parameters and process. 

The new social media guidance recently published by the PMCPA is a welcome development and will certainly help pharma companies ensure they uphold the high standards demanded by the Code of Practice, which the industry supports. However, there are some areas where additional clarity is needed that we have discussed, particularly when it comes to international communications. With an ever-increasing focus on regulatory compliance, it’s essential that pharma companies approach new guidance with a robust understanding of what is expected of them and how to adhere to these expectations. 

For more information on navigating these changing regulations and ensuring adherence to relevant guidelines and codes of practice, contact us today. Our team of experts can partner with you throughout your journey and help you develop compliant, secure social media strategies.

About Wendy Lloyd-Goodwin

Wendy is a solicitor with more than 20 years of professional experience in the life sciences sector. A  leading expert in pharmaceuticals, consumer well-being products and medical devices. Wendy has also built and managed in-house legal and compliance teams in several multi-national organisations.

She founded LS Law as she spotted a need for a support network built by lawyers for lawyers within the life science and pharmaceutical sector to help them build the best teams possible and provide a support structure for lawyers who would like career guidance and support in developing their career as a lawyer within the life science and pharmaceutical field. 

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. I also love first and foremost helping to solve others problems and challenges, whether that’s providing support to alleviate workload, or solving a business challenge. I get my biggest kick For me, from receiving positive feedback from my clients.  brings a smile to my face, and keeps me doing what I do. 

“To be honest, I have never dwelled on what it is like to be a woman within the legal industry, which is a traditionally male dominated environment. It is what it is, and I have developed my approach based on the personality dynamic of the team. The secret of good team dynamics is diversity. I have had bigger challenges, where I have worked in female dominated teams. Most lawyers worry about doing a good job, and can often feel challenged where they feel they are in competition with others, whether they are male or female. Having self belief and working, creating in  a good team dynamic regardless of gender is where I have focused my agenda.

“The commercial arm of the legal industry is traditionally a male dominated sector, and it was the oppression I faced in private practice as a newly qualified female solicitor which led me to retreat into what I felt would be a less oppressive environment – in-house. I also had to juggle the work life balance of developing my career, being the best at work, and also ensuring I was emotionally and physically available to care for my child, and the guilt which goes with never being at the school gates. These difficult challenges gave me extra motivation to overcome them. I had a vision and I kept that vision in focus – something I continue to do.  It’s important to remember why you do what you do, and to keep that vision in mind to help drive you forward.

“Every day there is a new challenge which I have not faced before and I am truly living by my mantra that you learn the most from challenges which you do not necessarily solve on the first attempt.  I continue to kick off embark on big projects which I know will not be easy, as in many cases I have not done them before, but must continue to push forward with in order to develop and grow the infrastructure of LS Law because that’s what’s needed,.  Pushing through the fear and doing it anyway! even though the change will be time consuming and sometimes painful.  These new challenges are not all going to plan, but we keep pushing moving forward, and I know we will get there eventually, because I don’t give up, whether that’s developing a new website (it’s still not done despite being almost a year in the planning) , changing our IT solutions (just don’t ask me about that one!), recruiting consultants and suppliers to provide us with new business functions both back office and additional service offerings (this is the exciting part but daunting as it adds more responsibility and hence management time and headspace). Don’t give up. Just keep pushing forward!”

Sophie Kirk – Paralegal – Life Science Law

“I believe as a young woman coming into the industry, that the legal sector is really putting an emphasis on levelling the playing field between men and women in the legal profession. From the application process to the promotion of a good work life balance, I believe the legal industry is starting to adapt and improve in order to allow women to enter the profession and stay within the profession if they decide to raise a family. This is so important as women deserve to be in the legal profession. Throughout my time studying the GDL and the LPC, there has been an equal split in the male to female ratios in the classroom. To see women gaining training contracts and vacation schemes, achieving things that our grandmothers couldn’t have done is incredible and really shows the momentum of women’s rights and the shift society has taken for women to thrive in the legal profession. I feel so blessed to have the support to pursue this career and I am excited to see where my legal career takes me.

“Entering the legal profession, the application process is tough and disheartening. However, as a woman, I do believe it has been harder as from my personal experience women doubt themselves more and have the less confident edge that men tend to embrace and exude. I think within any profession or any type of study that you do, you will always have an individual or a group of individuals who will voice their unwanted opinion about girls being lawyers. There will also be men who voice their opinion about the application process favouring women which can make you feel guilty or make a woman feel in some way singled out and targeted. Having the effect of making them feel less worthy than a man because we are being told the application process favours an individual because of their gender. I think it is important for an individual to remember their worth through their own intellect. To remove any stigma and embrace the fact that despite our gender we deserve to be accepted into the legal profession and that we have been accepted by our own individual strengths not by our gender.

“I think Covid-19 and the pandemic showed that incorporating new innovative thinking and technology can improve work life balance and increase productivity. As a woman there is pressure to raise a family and the decision to take a step back from a career to have children affects a lot of women. New technologies that benefit the work life balance and allow women to choose the option to have children and maintain a successful career can only be beneficial for society. However, I am an individual too young to be thinking of having children at this stage in my life. I do have a chronic autoimmune disease which can affect my health. To be able to stay at home and work or incorporate new technologies that allows more individuals with a chronic illness to work from home will benefit their health and longevity in the legal profession. Chronic health issues do not impact just women, they can affect anybody. To incorporate new technologies which benefit people with health issues and allow them to remain in the legal profession and thrive is beneficial to everybody.”

Tina Durward – Legal Consultant – Life Science Law

“When I had the usual careers advice conversation at school and told them I wanted to be a lawyer, the response was “the most you can hope for is to be a legal secretary” and so I did the course and by the end of the first year could touch type, had a GCSE in Law and a realisation that nope, I really wanted to be the lawyer! I financed myself through my legal education by working as a carer. At University I worked night shifts. It just about paid enough but, more importantly, taught me some valuable lessons, not least humility, determination, the power of laughter and the importance of dignity. 

“I have had such a varied legal career in the life sciences sector. It is an area of law that is so fascinating and retains that tangible ‘human’ element. For me personally, believing in, and caring about, what I am doing makes me the best kind of a lawyer I can be, and so whilst my gender may well have been a factor for others, consciously or not, I have simply refused to engage. In my mind a good lawyer is simply a good lawyer, much like a good person is a good person – it’s their work and actions that count, and they speak for themselves.

“I didn’t follow the ‘traditional’ career path  – my legal career in life sciences developed in-house, after joining J&J as an Administrative Assistant, after I had my son. Prior to that, my training contract with a sole practitioner fell through when he returned to private practice. Following which I spent several years working for a charity with the objective of developing leaders across all sectors of society and so not only did I have exposure to some amazing people, but I also gained valuable commercial experience and learnt to be resourceful (when I started secondees used to turn the server off at night before they went home)! I didn’t expect to pick up a career in law again, however, I had an amazing mentor at J&J who sat me down one day and said “enough is enough, you have to qualify”. With her support, I took the CILEX route back into the legal profession and subsequently converted to a Solicitor.

“It has been hard work and at times has been physically and mentally exhausting. It has required large doses of sheer determination, particularly when we decided to start our own business (naively from nothing) so my husband could pursue his passion as a motorbike mechanic when our son was a baby. I was juggling being a Mum, having a full-time legal career and supporting my husband with running his business. However, if I think about whether the challenges I have faced in my career have been gender-orientated, I can’t honestly say that this is the case. I feel I have the privilege of being a Mum, Wife and Lawyer and in all three, I have learnt the importance of simply being me, because in my experience when you genuinely care, it matters and it shows – gender is irrelevant.

“I have had multiple sole counsel roles (typically with little or no budget) and, consequently, learnt to be resourceful and use the tools I had to hand – whether creating a contracts library using OneNote, or a compliant infrastructure and self-service legal portal in SharePoint. I cannot stress enough the importance of enabling people to use and understand whatever technology you invest in, properly. Once you have that training and buy-in, not only do you enable and invest in your team, but it goes such a long way to future-proofing your organisation.”

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 with a company product, it must be reported.

*It is recommended that comments underneath advertising/ communications and direct messages to company owned or sponsored social media accounts are monitored for pharmacovigilance; alternatively, they can be restricted on certain social media channels.

Transparency

A pharma company’s involvement in anything social media should be clear and prominent so the viewer/reader knows from the outset. This also includes when any third party is acting on the company’s behalf or carrying out such activities such as: Sponsorship funded videos or podcasts. There should be a disclaimer of the company’s involvement at the beginning, not at the end, otherwise there will be a breach of code.

Third Party Responsibility

A pharma company is responsible for all material disseminated/ activities carried out by any of its social media channels, or those on which its personnel post on. Therefore, a pharma company is responsible for all Third parties who carry out activities on the company’s behalf, even if those third parties act contrary to the instructions they’ve been given by the pharma company. Even If the contract has ended the agency is still considered a third party.

Social Media Influencers

Social media influencers must be extremely well briefed about the requirements of the code. Companies will be held accountable for actions of contracted parties, even if they act contrary to the instructions given to them. Therefore, a pharma company must exercise caution when working with social media influencers.

Responsibility of Employees

Pharma companies should assume that the Code would apply to all work-related, personal social media posts by their employees on platforms inside the UK, within the Code’s jurisdiction unless for very clear reasons, it could be shown otherwise

Links, Tagging, Hashtags

Any material associated with a social media post, including the link within the post is regarded as being part of the post. How the link is structured, and what words the link contains will be considered in the assessment of what is promotional. This includes a combination of hashtags used. Account(s) mentioned

should be appropriate and care must be taken to ensure they are mentioned respectfully and only brought into the relevant discussions. Companies must ensure that linked content is appropriate and does not promote a POM to the public. It is the company’s responsibility to ensure the link in the company post is both appropriately named and clear whether the link is to the pharma company material/ website or non-company material/ website.

Posting/Sharing/ Re-Sharing

Companies must ensure that  shared/reshared content is in line with the ABPI code and is approved and certified if necessary. Anything which alerts a person’s connections to the content will be seen as a type of sharing. Engaging with a post e.g., liking the post on LinkedIn, might alert one’s connection to the content. Therefore, liking content on LinkedIn is considered to be a type of sharing/ resharing. This will only apply to employees/ third parties contracted to the pharmaceutical company or the company itself.

The guidance strongly advises that the Company provide training to their employees toensure compliance with the Code’s rules on social media.

Content Posted from Other Companies Which Relates to Your Company/Your Products

A pharma company is responsible for its own employees and cannot be responsible for what another pharma company/ pharma company employee does. You will not be in breach of the Codes if another company posts/ mentions your company or your products. What will bring your company into a breach of the codes is if a UK based employee likes or comments on that content. Then it will be seen as promotional and there will be a breach.

Advertisements and Clinical Trial Recruitment

Clinical trial recruitment must be targeted at appropriate demographic and must not raise unfounded hopes of a successful treatment. It must avoid referring to specific products and include a description that supports appropriate people/ patients in the disease areas to find out more about the clinical trial. A pharmaceutical company that wants to recruit over social media must consider all of the other applicable codes, laws and regulations including the requirements of the Health Research Authority (HRA).

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 global understanding of different business models, industries and cultures working in both B2B, B2C business within Europe, Asia and America and industries as diverse as Retail and Automotive.

Fabrina also has a strong understanding of the subject matter of compliance and in particular the areas of Competition Law, Anti-Bribery and corruption having worked extensively across many sectors offering council and training to facilitate best practice in this field.

We’d like to take this opportunity to welcome Fabrina onboard and look forward to sharing more about her part in supporting LS Law clients in the future. Fabrina is certainly one to watch grow and develop within the LS Law family.

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, something which has been more critical than ever with Covid-19 vaccines present in our NHS.

Work Experience

With Schlich, a leading European Patent and Trademark attorney firm, I had the privilege to gain valuable work experience related to IP concepts in medical research areas. With clients such as pharmaceutical companies, my role specifically focused on comparing existing claims with prior art and highlighting any key points of distinction. Mind-opening tasks included exploring topics like induced pluripotent stem cells – ideas that are shaping the way we understand healthcare advances today. 

Continued Development

Completing the White & Case US IP Virtual Learning programme on Forage Website enabled me to practically apply my medical knowledge and gain a deeper understanding of subject matter related to Intellectual Property law. The simulations, educational modules and oral advocacy I experienced all contributed towards deepening this conviction that specialising in IP Law was something I wanted to do – helping progress the world of medicine with an interdisciplinary approach.

Life at LS Law

Working with LS Law, I have the opportunity to be part of an ever growing global team. From keeping on top of regulations in the UK for Cannabinoids and OTC drugs in America to monitoring clinical trial rules across East Asia and adding a scientific edge to our blogs – this is truly one unique place where hard work pays off.