COVID-19: Advice from the legal experts
COVID-19: Advice from the legal experts
Obtain guidance from some of the EU Pharmaceutical Law Forum speakers on how pharmaceutical companies can effective
COVID-19: Advice from the legal experts
May 2020
Introduction & Speaker Contents
The impact of COVID-19 on the pharmaceutical industry has proven to be challenging, but also eye-opening.
Pharmaceutical companies have faced pressure to manage disturbances in supply coupled with unprecedented demand, which has led to uncertainty in the legal landscape.
With this in mind, how can the industry best respond, and how will these changes impact the future of the pharmaceutical landscape?
Informa Connect reached out to some of this year's EU Pharmaceutical Law Forum speakers for advice on how best to mitigate the challenges facing the pharmaceutical industry.
Read on to discover what the legal experts had to say about the impact of COVID-19, and how the pharmaceutical industry can adapt in the current climate.
Jump to any article using the contents on the following page, or at any time using the Contents menu in the top left. There you can also download this eBook as a PDF.
Alexander Roussanov, Partner
Arnold & Porter, Belgium
Annabelle Bryndonckx, Partner
Vladimir Murovec, Supervising Associate
Simmons & Simmons, Belgium
Ingrid Vandenborre, Partner
Skadden, Arps, Slate, Meagher & Flom LLP , Belgium
Bart Van Vooren, Associate
Peter Bogaert, Managing Partner
Miranda Cole, Partner
Covington and Burling LLP, Belgium
Sally Shorthose, Partner
Bird & Bird, UK
William Long, Partner
Sidley Austin LLP, UK
Arnold & Porter
Alexander Roussanov, Partner
Alexander Roussanov, a former senior legal adviser in the Legal Department of the EMA, focuses his practice on a broad range of issues related to the life-cycle of medicinal products and medical devices. His experience includes product classification, authorization and conduct of clinical trials for medicinal products and clinical investigations for medical devices, marketing authorization for medicinal products and CE marking of medical devices, pharmacovigilance and device vigilance, marketing and promotional activities, and interactions with health care professionals.
Alexander has extensive practical experience assisting clients in ensuring compliance with the GDPR. He advises clients concerning many aspects of the GDPR that are of particular importance in the Life Sciences sector.
With COVID-19 changing the dynamic of many businesses, what are your top tips for pharmaceutical clients during this time?
Pharmaceutical companies must make sure that they anticipate as much as possible the consequences of the COVID-19 outbreak, including increased demand for their medicinal products, potential shortages and import or supply issues.
The COVID-19 may also impact and delay the conduct of clinical trials, regulatory submissions and overall regulatory strategy. This could include delays in the conduct of paediatric clinical trials, generation and regulatory review of the related clinical data and delays in the submissions of applications for paediatric extension of SPCs.
Have you experienced any of the below issues?
- Shortages and supply issues
- Delays in clinical trials
- Delays in submissions of applications
- No, I've not yet been impacted
Do you anticipate the COVID-19 pandemic changing the legal landscape for pharmaceutical clients?
If so, how?
It is yet unclear if the COVID-19 would lead to changes in the regulatory regime in the EU. The current EU legal framework and the exemptions and flexibilities offered by the competent authorities seem to be overall effective in the present situation.
Simmons & Simmons
Annabelle Bruyndonckx, Counsel and Vladimir Murovec, Supervising Associate
Annabelle specialises in regulatory and compliance advice on behalf of medical technology and digital health businesses, pharmaceutical and consumer health companies and significant players in other highly regulated industries.
Annabelle advises on a wide range of issues from the R&D phase and product qualification/classification, to (early) market access (pricing and reimbursement) and (pharmaco) vigilance, covering all aspects relating to distribution, advertising, tendering and liability issues. Annabelle frequently liaises with Belgian/EU regulators and industry associations on behalf of industry players.
In healthcare compliance, Annabelle has significant experience in local and global cross-border projects, approval and transparency procedures, SOP implementation, and bribery/anti-gift measures.
Annabelle joined Simmons & Simmons in 2013, after more than 14 years at another international law firm, where she headed the Pharmaceuticals & Healthcare group. She has been a part time lecturer at the Catholic University of Louvain from 1997 to 2003.
Annabelle is member of the European Food Law Association, the steering committee of healthy measures (Science Business) and the Belgian Regulatory Affairs Society (BRAS) where she is also a board member and the President of the Education Group organising training sessions for BRAS members. She is frequently invited to speak at international conferences and has published numerous articles in legal and trade journals relating to regulatory matters.
Vladimir specialises in regulatory and compliance advice on behalf of medical technology and digital health businesses, pharmaceutical and consumer health companies, and significant players in other highly regulated industries.
He advises on a wide range of issues from the R&D phase and product qualification / classification, to (early) market access and vigilance / pharmacovigilance, covering all aspects relating to distribution and import-export, marketing and product information, and labelling of regulated products. He frequently liaises with Belgian and EU regulators and industry associations on behalf of industry players.
Vladimir assists Healthcare & Life Sciences companies on the digital aspects of their businesses, from the early development of e-health solutions up until digital and D2C marketing tools and advertising strategies.
In healthcare compliance, Vladimir has significant experience in local and global cross-border projects, approval and transparency procedures, SOP implementation, and bribery/anti-gift measures. He has been seconded to several Compliance departments within Healthcare & Life Sciences businesses, covering EMEA and Benelux.
With COVID-19 changing the dynamic of many businesses, what are your top tips for pharmaceutical clients during this time?
"The first tip is staying aware of the legislative changes and all the guidance that is being released."
Annabelle Bryndonckx, Simmons & Simmons
Vladimir Murovec, Simmons & Simmons
Not only European guidance but also within each country. There are new laws and guidance being released constantly.
For example, shortage is a big issue right now. A country could ban certain exports and restrict certain distribution channels, but these laws can change from one day to another. So, it’s important at this point in time to just keep on top of the changes at both the local and industry level.
We have found that when we are giving advice, we are needing to refine and change that advice a few days later because of the constant change in regulation. The law is evolving quickly and we need to take into account that these interim measures are in exceptional circumstances. However, some of these measures will have an end date, so it’s imperative to be aware of the daily changes.
"The second tip corresponds to the various initiatives being brought in due to the most important issue industry is facing right now – the shortage of drugs."
Annabelle Bryndonckx, Simmons & Simmons
Vladimir Murovec, Simmons & Simmons
This is a big concern, as some specific drugs and active pharmaceutical ingredients (API) are lacking to fight COVID-19. This is resulting in purchasing restrictions on global drugs like paracetamol. Many measures like purchase restrictions are being updated and created to manage this shortage. So, clients need to be in direct contact with their distributors or manufacturers to see what the status is, what ingredients and drugs they have and what they don’t.
Regarding the problems linked to the supply of oxygen in due time of, for example, we have been assisting on the creation of a platform that will help supply oxygen and allocate it to hospitals and care institutions in a more systematic and appropriate way in the current climate – with a ticket system. We can see that there is a clear reorganisation of the market.
However, with these concerns and innovations has come a higher level of interaction between competent authorities and pharmaceutical companies that provide these products, because distribution is being monitored day-to-day to ensure there is enough supply in care centres and hospitals.
The advice we would give to our clients regarding this shortage, and management of supply, would be to increase their contact with the authorities. They are doing a great job of responding to pharmaceutical companies quickly and they are easy to contact. Of course, they are busy, but they are very responsive to COVID-19 questions and we’ve experienced that ourselves.
What's your biggest concern amidst COVID-19?
- Shortage of ingredient supplies
- Unable to obtain guidance from authorities
- Staying up-to-date on legal developments
Do you anticipate the COVID-19 pandemic changing the legal landscape for pharmaceutical clients? If so, how?
Due to the shortage, we think the laws and guidelines will need rethinking. A shortage like this shouldn’t happen and we shouldn’t be so dependent on other countries to help out in these circumstances. We will need to rethink the stock and manufacturing of products.
In terms of distribution and market share, let’s return to the oxygen distribution issue. In Belgium, there is a company that holds a large percentage of the share of oxygen in the market. That company can’t deliver alone. This begs the question, what do we do in a pandemic like this and which tools can we create to help us if there is a next time?
One change we anticipate could be around prevention of shortages by supporting local manufacturers – as they will be in the first row to supply local markets.
Annabelle Bryndonckx, Simmons & Simmons
Vladimir Murovec, Simmons & Simmons
Many countries have seen a change in the reimbursement procedure – which has been stopped. For instance, in Belgium , as of 13th of March all procedures stopped and changes are expected in the future to the criteria on the reimbursement side.
We have also seen a lot of flexibility in EU regulatory guidelines, including on drug submissions and packaging and labelling, as there just isn’t enough time to follow the usual procedures. It will be interesting to see if this flexibility will carry over after the pandemic, even if only under certain conditions.
We could even see a surge in the creation of more digital tools for patients to be able to conduct trials at home more frequently. Of course, the industry is already very digital, but this could push businesses into an even more digitalised world.
A large change is coming through trying new things that were previously not regulated – or even forbidden / not reimbursed. For example, the direct monitoring of patients. In Belgium you require physical contact with the patient for reimbursement purposes but, now that there is a necessity for less direct contact, that legislation has begun to change. And it will be interesting to see if these changes will be implemented in the future, or even if there are any benefits to these new procedures and tools.
Annabelle Bruyndonckx and Vladimir Murovec created a summary of the regulatory updates and changes in the Belgium market, which serves to help the pharmaceutical and medical device industry in keeping up-to-date with everything.
If you would like to read this summary, you will find it here:
VIEW THE SUMMARY
Skadden, Arps, Slate, Meagher & Flom LLP
Ingrid Vandenborre, Partner
Ingrid Vandenborre is the partner in charge of Skadden’s Brussels office. Her practice focuses on EU and international merger control and competition law enforcement. She has consistently been named as a leading practitioner in Who’s Who Legal guides in both competition and life sciences and was recognized by Global Competition Review on various occasions. In 2016, she received the ILO Client Choice Award for the category of EU Competition and Antitrust, awarded by The International Law Office in recognition of individual partners who excel across the full spectrum of client service, and in 2018 she was shortlisted for “Transatlantic Disputes/Regulatory Lawyer of the Year” at the Transatlantic Legal Awards, hosted by Legal Week and The American Lawyer. She currently serves as Non-Governmental Advisor to the intergovernmental International Competition Network (ICN).
Her practice extends to EU and non-US merger control, and antitrust enforcement issues and investigations, both with the EU Commission and EU Member State competition authorities. Recent and ongoing representations include the immunity and leniency applicants respectively in relation to the EU Commission’s power cables and car battery recycling cartel decisions, and the appeal proceedings currently pending before the European courts against these decisions. She is also representing several defendants in the EC’s ongoing geo-blocking investigations in relation to hotel bookings, Aspen in its investigation relating to alleged excessive prices by the EC Commission, and a generic company in relation to the appeal before the European Court of Justice against the Commission’s first reverse payment patent settlement decision. Her recent merger control experience includes the representation of NXP in relation to the acquisition by Qualcomm, Rockwell Collins, Inc. in its acquisition by United Technologies Corp. and Key Safety Systems in its acquisition of assets from Takata Corporation.
With COVID-19 changing the dynamic of many businesses, what are your top tips for pharmaceutical clients during this time?
Around the world, competition authorities see the necessity of temporary cooperation between businesses to deal with the COVID-19 crisis and avoid shortage of essential supplies.
"While identifying and addressing needs is critical, pharmaceutical companies also should be cautious not to assume that exceptional times justify a departure from strict competition law compliance."
Ingris Vandenborre, Skadden, Arps, Slate, Meagher & Flom LLP
Unless temporarily exempted from scrutiny under emergency frameworks, companies should be cautious not to exchange individualized commercially sensitive information or coordinate their actions with competitors.
However, companies should identify where cooperation opportunities may exist or new relationships can be forged to help them better address customer needs and shortages, actual or anticipated. In doing so, however, they should be careful to document any measures that would entail necessary and temporary cooperation, specifying their public policy goal, as well as the absence, or the exhaustion, of any alternative solutions. For example, it would be better to resort to the aggregation and anonymization of information by a third-party to mitigate the risk of unlawful collusion where possible.
Where collaboration is identified as necessary, it will in most cases be advisable to discuss the planned cooperation with the relevant antitrust agency(ies). In that context, it will be important to ensure that a process is put in place to ensure that all exchanges with a competing provider can be documented and provided to the competition agency if required.
Also outside any potential coordinated action, in the current circumstances, it will generally be advisable to over- rather than under-communicate where possible. Companies should be clear and consistent in the communications with their trade partners on any change or delay in approach for example, where necessary setting out the reason and purpose for their policies and decisions. This includes for example communications with customers, distributors as well as suppliers, about the scope and the basis for any changes in prices, costs, supply, output, forecasts, or other economic terms, or delays in implementation or payment. It may also extend to regulatory authorities.
This is particularly relevant for areas where the company concerned holds a material share of supply. In areas of potential market power, it will be important to consider the scope and potential effect of implementing unilateral measures on customers, distributors or competing suppliers under the current circumstances.
Finally, as weeks pass and competition agencies refine their approaches and processes, companies should continue to monitor how competition authorities are likely to assess competitor collaboration. If in doubt, they should always err on pro-actively seeking informal guidance.
Do you anticipate the COVID-19 pandemic changing the legal landscape for pharmaceutical clients? If so, how?
It remains to be seen whether, and how, competition authorities will further adjust competition rules and policies as the crisis evolves. It is almost certain, however, that industrial policy concerns will play a greater role in antitrust enforcement going forward. This will affect merger control review in the EU, particularly for transactions involving European pharmaceutical assets or innovation, and greater scrutiny in areas of pricing or supply of pharmaceuticals, a trend which has already started prior to the crisis with the greater degree of enforcement against alleged excessive pricing in pharmaceuticals. The pharmaceutical sector will likely remain a key focal point for antitrust enforcement by the European Commission and the EU Member States.
Covington & Burling LLP
Bart Van Vooren, Associate on behalf of Peter Bogaert, Managing Partner and Miranda Cole, Partner
Peter Bogaert is a managing partner of the Brussels office, and has a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert's practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he represents numerous innovative life sciences companies, including start-ups, as well as several industry associations.
Chambers Global notes that a client said “He is an extremely experienced professional with broad expertise and provides sensible and well-balanced solutions." He is consistently ranked by PLC as one of the leading life sciences lawyers globally and Legal 500 EMEA and Chambers Europe note Mr. Bogaert's prominent regulatory pharmaceutical and environmental practice. Legal 500 EMEA (2011) noted that he is "a superb lawyer who is very pleasant to work with." Mr. Bogaert regularly writes and speaks on life sciences issues. He is a founding member of the Brussels Pharma Law Group.
Miranda Cole is a partner in the EU Competition team, working from the Brussels and London offices. She practices all aspects of EC, international and UK competition law and policy, and has more than 18 years of experience in the field. Miranda’s competition law expertise encompasses merger control, compliance, abuse of dominance, vertical and horizontal issues under Article 101, advisory work and actions before the European courts in Luxembourg.
Her practice has a particular focus on advising companies active in the technology, communications and media, software and ecommerce, and aviation sectors. She advises clients on the competition issues raised by IP, data and technology interfaces, including access issues, standardization, remuneration and interoperability. She is increasingly advising clients regarding competition raised by algorithms and other implementations of AI, and connected devices and other Internet of Things applications.
Miranda was recently named among the Politico “2017 Women Who Shape Brussels” list, a group of “20 powerhouses driving debates and influencing policy in 2017.” Miranda is also on the Board of Editors of The Journal of Robotics, Artificial Intelligence & Law.
Bart Van Vooren has a broad European law practice advising innovative multinationals and start-ups on pharmaceuticals, food, and cosmetics.
He leads the practice on compliance with the Nagoya Protocol to the Convention on Biological Diversity (a set of rules to combat bio-piracy). In this area, Mr. Van Vooren has unique experience working for pharmaceutical, cosmetics, food, and biotech companies across four continents.
He has extensive experience in EU litigation, having handled more than 30 cases before the EU Court of Justice for trade associations, companies, and the Belgian government.
Finally, Mr. Van Vooren advises companies on complex issues of EU and public international law that are not typically familiar to practicing attorneys. Hence his significant role in clients’ Brexit preparedness work.
With COVID-19 changing the dynamic of many businesses, what are your top tips for pharmaceutical clients during this time?
Even though the short term legal and regulatory urgencies continue to take over our lives, it is important not to lose sight of the long term impact.
"...it is important not to lose sight of the long term impact."
Bart Van Vooren, Covington & Burling LLP
For instance, the urgency and eagerness of public authorities allows companies to attain some of their legal and public policy goals that otherwise would have been unattainable.
Do you anticipate the COVID-19 pandemic changing the legal landscape for pharmaceutical clients? If so, how?
Greater acceptance of initiatives in the field of public health at EU level: The degree to which the EU has been granted powers by the Member States with the Lisbon Treaty (and prior treaties) is clearly visible across the spectrum of measures the EU has taken so far in responding to the crisis. Article 168(1) TFEU states that Union action on public health shall “complement national policies” towards “the fight against the major health scourges.”
"In the catalogue of EU competences, public health is amongst the weakest powers that the member states have granted to the Union."
Bart Van Vooren, Covington & Burling LLP
For instance, the Joint Procurement Instrument is a good example of this. It is “optional” for the member states to use it, and a specific procurement initiative will only have effect if at least 4 member states sign up. By contrast, the medical device and in vitro diagnostic medical device regulations are based on article 114 TFEU. This is the competence to approximate the member states’ laws to ensure the functioning of the internal market. This is a far ‘stronger’ EU competence than that granted in public health. For instance, on that basis the EU institutions have extended the MDR’s entry into force by one year.
Next, in international trade relations, the EU has exclusive competence to act. That was the legal basis for an EU-wide export ban on medical equipment to third countries. In summary, the EU has, or has not, been granted, that impacts its ability to respond “as one.” Based on the current treaties, the EU can act swiftly and coherently to regulate the exports of medical equipment to third countries, and can impose or delay regulatory requirements that devices must comply with to be placed on the market.
"But it has very limited powers to influence how those devices reach health care professionals or citizens. That is largely a member state power."
Bart Van Vooren, Covingtong & Burling LLP
For instance, in the Netherlands there was an informal agreement to supply “own” (i.e. Dutch) clients first; and on 1 April 2020, Belgium adopted a blanket export ban with limited exceptions for supplies destined to other EU countries. Although Belgium changed its rules a week later, the initial reflex was unmistakable. The unified voice amongst the 27 in responding to Brexit was completely absent in responding to COVID-19. However, we expect that COVID-19 will spawn new initiatives to reform the EU and Member States, and perhaps even at an international level – see below.
"Although EU treaty change is unlikely, we consider it likely that in the wake of the pandemic, there will be a much greater political acceptance of EU-wide initiatives in the field of healthcare."
Bart Von Vooren, Covington & Burling LLP
This will certainly impact the Commission’s Pharmaceutical Strategy for Europe that was initially expected for Q4 of 2020. It looked like this could be further delayed but more recently there are signs it could even be accelerated.
As regards competition law, on 8 April 2020, the European Commission published its Communication on the “Temporary Framework for assessing antitrust issues related to business cooperation in response to situations of urgency stemming from the current COVID-19 outbreak”. The Commission stated that the current, exceptional circumstances “may trigger the need for undertakings to cooperate with each other in order to overcome or at least mitigate the effects of the crisis to the ultimate benefit of citizens” (para 3).
The purpose of the Framework is to: (i) explain the main criteria that the Commission will follow when assessing possible cooperation projects between undertakings aimed at addressing the shortage of essential products and services during the COVID-19 outbreak; (ii) describe the exceptional procedure that the Commission has set up to provide, where appropriate, ad hoc ‘comfort letters’ to undertakings in relation to specific cooperation projects. The Framework applies to forms of cooperation between undertakings aimed at ensuring the supply and adequate distribution of essential scarce medicinal products and medical equipment (presumably not only medical devices but also personal protective equipment), as well as related services, during the pandemic. Undertakings currently active in the health sector can benefit from it, but so can those active in other sectors that are retooling to focus on scarce products.
World Health Organization (WHO) may be reformed following the COVID-19 crisis.
First, The World Health Assembly (WHA) was scheduled for next month. It was initially cancelled, but now it is likely that there will be a virtual WHA entirely focused on COVID-19. On 15 April, the EU mission proposed that all WHO member states would “Work collaboratively at international level to develop, test and produce safe, effective, quality diagnostics, medicines and vaccines for the COVID-19 response, and to facilitate the equitable and affordable access of people to them, including through voluntarily pooling their intellectual property for all COVID-19-related medical interventions.”
Second, In April 2019, the WHA decided that: “WHO is ready to explore, in close dialogue and collaboration with all relevant partners, possible options, including codes of conduct, guidelines and best practices, and global multilateral mechanisms, for pathogen access and benefit sharing.” Even before the COVID-19 crisis, it was contemplating a new international regime that would have the following focus: “food safety, antimicrobial resistance, tuberculosis, HIV infection, malaria, and emerging high-threat pathogens like the Middle East respiratory syndrome coronavirus, and Zika, Ebola and Lassa viruses, as well as unknown future threats.” COVID-19 is likely to give a significant boost to these initiatives.
Bird & Bird
Sally Shorthose, Partner
As one of Bird & Bird's most experienced intellectual property partners, specialising in transactional IP matters, Sally offers a wealth of knowledge to businesses at the cutting edge of research, development and technology, in a variety of sectors for which IP is of prime importance.
Providing the full array of commercial advice and support in IP, she leads the team delivering licensing, partnering and exploitation agreements, and research, development and marketing collaborations. Sally also advises clients on regulatory and 'freedom to operate' issues, and manage significant due diligence matters.
As a transactional IP lawyer, Sally provides advice on the protection and exploitation of IP rights, both in stand-alone transactions and as part of acquisition, divestment or investment activity.
Before joining Bird & Bird in 2006, she was head of IP & Life Sciences at another global law firm, after spending 11 years in-house firstly as senior legal adviser at ICI/Zeneca and latterly as Legal Director of Novartis UK. This experience has given her significant insight into the need for pragmatic commercial advice.
As well as speaking on IP generally, and regulatory life sciences topics particularly, Sally contributes to leading publications, and edits The Guide to EU Pharmaceutical Regulatory Law (Kluwer Law International), which is written entirely by the team at Bird & Bird with contributions from many offices. She also leads the Bird & Bird Brexit Steering Committee and write and speak on the implications of Brexit, particularly in relation to the life sciences and medical devices industries.
With COVID-19 changing the dynamic of many businesses, what are your top tips for pharmaceutical clients during this time?
In such a fast moving regulatory environment, I would ensure that I have easy and regular access to a source of reliable and up to date information so that pharmaceutical companies can be managed as efficiently and proactively as possible.
"I find that industry associations and the CBI have loads of helpful information and the CBI is holding daily update webinars."
Sally Shorthose, Bird & Bird
I have been reviewing some agreements for potential COVID-19 related issues (a bit like ground hog day after Brexit preparation). I think some pre-emptive review of key agreements, and bearing the knock on effect of COVID-19 on negotiated agreements is again something to be borne in mind.
From a social point of view, I think having a strict limit on the amount of news watched or heard is a great idea; my mental health improved considerably when I stopped waking up to and going to sleep with COVID-19 related news.
There is lots of information about how to cope with isolation and as far as keeping in touch with colleagues is concerned, I find video calls are warmer and more engaging than phone calls.
Do you anticipate the COVID-19 pandemic changing the legal landscape for pharmaceutical clients? If so, how?
At Bird & Bird we have been reviewing the impact of the virus and associated guidelines, regulations and legislation in various countries – there is a lot to cover and I believe it will take some time to really get to grips with the long term impact.
Pharmaceutical companies have brighter future than many in other sectors and there will be great pressure to secure vaccines and remedies. Legal teams may well have to be extremely agile and imaginative to cope with the associated pressure.
Sidley Austin LLP
William Long, Partner
William Long is a global co-leader of Sidley's highly ranked Privacy and Cybersecurity practice and also leads the EU data protection practice at Sidley. William advises international clients on a wide variety of GDPR, data protection, privacy, information security, social media, e-commerce and other regulatory matters.
William has been a member of the European Advisory Board of the International Association of Privacy Professionals (IAPP) and on the DataGuidance panel of data protection lawyers. He is also on the editorial board of e-Health Law & Policy and also assists with dplegal (“data privacy” legal), a networking group of in-house lawyers in life sciences companies examining international data protection issues.
Representative matters have included:
- Advising numerous international companies on the GDPR.
- Advising companies on data privacy issues with Big Data, Internet of Things and profiling.
- Advising a global e-commerce company on dealing with an international data security breach.
- Assisting a global manufacturing company with a global data protection project including implementation of Binding Corporate Rules.
William was previously in-house counsel to one of the world’s largest international financial services groups. He has been a member of a number of working groups in London and Europe looking at the EU regulation of e-commerce and data protection and spent a year at the UK’s Financial Law Panel (established by the Bank of England), as assistant to the Chief Executive working on regulatory issues with online financial services.
William is recognized in Chambers UK 2019 for Data Protection and Information Law, with sources telling the publication he brings “a broad depth of knowledge on the key areas of law,” whilst in the 2017 edition, clients cite him as “very knowledgeable, very practical and always solution-driven.” He is recognized in the LMG Life Sciences Guide 2014 for Intellectual Property and Who’s Who Legal 2017 for TMT. He has also been listed in Best Lawyers 2019 for Privacy & Data Protection Law and Who's Who Legal: Data 2019. William is recognized for both Data Protection, Privacy & Cybersecurity and Pharmaceuticals & Biotechnology in The Legal 500 UK 2017, with clients noting that his “‘forward-thinking and proactive approach keeps him ahead of the curve’” and describing his advice as “‘thorough, timely and on the leading edge.’” He is also included in the 2018 edition of Best Lawyers for Privacy & Data Protection and is listed for Data Security in Who’s Who Legal: UK Global Elite Thought Leaders 2019.
William is also the author of a new book on the EU General Data Protection Regulation and a contributor to a number of books on data protection, including leading legal text books published by BNA in the area of privacy, cloud computing and the use of health data. William has been interviewed widely for his thought leadership, including in such leading publications as the international New York Times, Financial Times, Guardian and writes for a number of publications including Data Protection Law & Policy, Computer Weekly, Cloud Pro and CIO Today.
With COVID-19 changing the dynamic of many businesses, what are your top tips for pharmaceutical clients during this time?
Develop a COVID-19 Privacy Protocol that adequately addresses what, how and when personal data should and should not be collected, used or shared, as well as the enterprise-wide security measures in place to protect the data in transit and at rest and how long such data should be retained. Revise data privacy and security policies as appropriate.
Vendors and Supply Chain: When entering into new vendor agreements or renewing existing agreements, companies should carry out appropriate due diligence and ensure that proper controls are in place to ensure protection of material or sensitive confidential information or personal data, including diligence on key vendors’ business continuity planning. As companies manage supply chain disruptions, they should focus on: (1) how to minimize the risk; (2) how to prepare for and address force majeure declarations from suppliers and customers; and (3) how to make the company fit for future supply chain disruptions.
Remote Working and Information Security: Companies should regularly communicate with their workforce about common remote-working risks to be alert for. Companies should also identify solutions to help protect against unauthorized access to systems and connections, such as company-approved secure computer software and hardware, devices, Virtual Private Networks (VPNs), email and conference lines, and secure WiFi and data storage accounts. Companies should also review and update their incident response plans as necessary to address the increased risks resulting from remote working and the potential for key stakeholders to be delayed or unresponsive during an incident.
"Consider also the need to revise guidance to personnel on how to respond to an incident and ensure multiple backup alternatives for key personnel, with updated contact information, in the event some personnel are sick or indisposed."
William Long, Sidley Austin LLP
Clinical Trials and Drug Safety: Sponsors should: (i) conduct a risk assessment as the risks and disruptions caused by the pandemic may affect the benefit-risk ratio of a clinical trial – including, as it relates to the ongoing monitoring of the trial; (ii) where required, implement amendments to the protocol to address the risks identified and mitigate their effect on patient safety and data integrity; (iii) ensure they are familiar with the most recent guidance published at both an EU and national Member State level.
"From a drug safety perspective, this would include continuous monitoring of the EMA’s publications regarding new treatment recommendations with certain pharmaceutical products which could increase the risk of being infected by COVID-19; and (iv) consider the impact of the pandemic on patients’ visits to the sites"
William Long, Sidley Austin
.Interactions between Sales Reps and HCPs: Companies will need to assess whether the communications between Sales Reps and HCPs would fall within the scope of the e-Privacy Directive’s requirements as constituting “unsolicited electronic direct marketing” and, in turn, require consent.
Do you anticipate the COVID-19 pandemic changing the legal landscape for pharmaceutical clients? If so, how?
From a life sciences regulatory perspective, we expect the pandemic could potentially trigger the adoption of measures authorizing some deviation from the regulatory requirements at EU and Member State level.
More generally, we think COVID-19 and in particular, the increase in remote working will likely accelerate a previously slow shift towards a digital workplace.
"Further, the pandemic has highlighted the increased potential offered by novel technologies, not only in the fight against COVID-19 (e.g., through surveillance and treatment) but also in facilitating companies’ digital transformation."
William Long, Sidley Austin LLP
However, with this comes huge privacy and information security implications. In turn, companies will need to ensure that whilst embracing technology they also continue to assess and mitigate the risks to the privacy of individuals concerned.
Want more advice?
Join us at EU Pharmaceutical Law Forum, 17 - 19 November 2020, in Brussels.
EU Pharmaceutical Law Forum
17 - 19 November 2020 | Brussels
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