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Issue 33 | September 2021 www.plg-uk.com
Business Development
& Licensing Journal
NEW FEATURE
In Conversation with…
Leaders in Business Development
Drug-Device Combinations The Value of Market Access Confidential Information:
and the MDR p.18
www.plg-uk.com Insights1 p.4
Business Development and Licensing Journal Beyond the NDA
Issue 33 | September 2021 p.11
C O N T E N T S
Editor’s Welcome
03 Umaima Ahmad | Editor
Understanding the Value of Market Access Insights
04 for Licensing Deals
Nerea Blanqué-Catalina, Raphaël Metrop, Romain Finas |
Alira Health
Beyond the NDA: Dealing Effectively with
11 Confidential Information
Jennifer Pierce | McCarthy Denning
Drug-Device Combinations under the EU Medical
18 Devices Regulation: What do pharmaceutical
companies need to do now?
Tasmina Goraya | Taylor Wessing LLP
In Conversation with… Marco Cerato, Glenmark
25 Pharmaceuticals
Umaima Ahmad | PLG UK
MDR has arrived and IVDR is coming down the line:
32 are you prepared?
Alison Dennis | Taylor Wessing LLP
www.plg-uk.com Business Development and Licensing Journal Issue 33 | September 2021
2
Welcome
It would be remiss to begin this journey without first thanking and recognising the
numerous achievements of my predecessor Sharon Finch, from whom I am privileged to
take the editorial baton after a whopping 15 years and 32 issues. I would also like to
acknowledge the unwavering support of Adam Collins and Linda Sterrett in helping me to
pull this first issue together.
Aiming to keep our readers at the forefront of all things deal-making, we will continue
sharing the latest insights and updates: in this season’s issue, we break down ‘market
access’ and understand why having real-world market access insights are highly valuable
for licensing transactions (page 4). We also look, beyond the NDA, at the many factors
that can impact the level of protection afforded to confidential information across various
jurisdictions, including exchange control laws (page 11), and, in an exclusive double-feature from Taylor Wessing,
we take a comprehensive look at what the new EU Medical Devices Regulation means for drug-device
combinations (page 18), and how to prepare ahead of the IVDR becoming fully effective (page 32).
We also introduce a new feature, titled ‘In Conversation With…’, (page 25) which is intended to give readers an
informal introduction to some of the leading professionals in the field. We are delighted to have had the pleasure of
launching this inaugural feature with the brilliant company of Glenmark’s EVP of Business Development, Marco
Cerato, in a conversation that takes us through his background and career milestones and provides an insight into
business development strategy at Glenmark, which we hope you will enjoy reading.
In summary, you’ll find all of what you would usually hope to see with some additions. We want to keep the BD&L
Journal interesting, relevant and helpful to our readership and so we invite you to share your feedback through
completing a short survey (page 36).
Deal activity in the first half of 2021 more than doubled versus the same period in 2020, with a more than 400%
increase when assessed by deal value (PwC analysis). The year had already seen newsworthy transactions
including Jazz Pharmaceuticals’ $7.2bn acquisition of GW Pharmaceuticals, and Nordic Capital’s $846m acquisition
of Advanz, and significant deal-making activity has continued well into Q3, with a shareholder vote expected
imminently on Advent’s $8bn acquisition bid for rare disease specialist Swedish Orphan Biovitrum. With the
pandemic having exposed the sector’s heavy reliance on manufacturers and CROs in countries hard-hit such as
India, we have also seen much decisive action with companies closing deals to secure and de-risk their long term
supply chains.
In July, the UK government revealed its ten-year ‘Life Sciences Vision’ which aims to apply learnings from the
pandemic, where adjustment of red tape saw accelerated solutions developed and delivered for Covid-19, to other
disease areas. Ambitions include boosting investment into R&D to 2.4% of GDP by 2027, improving clinical trial
legislation and expediting regulatory assessments. We will be looking keenly to see how this might influence
strategy for pharmaceutical and life science companies with a presence in the UK.
Finally, as many of us transition back to working in the office, later this month, the PLG will be holding its first face
-to-face meeting in the UK since the pandemic began, and I hope to see some of you there. For our readers outside
of the UK, I look forward to continuing to connect virtually at various events until next year’s IPLS symposium in
Brighton.
Umaima Ahmad
Editor
www.plg-uk.com Business Development and Licensing Journal Issue 33 | September 2021
3
M A R K E T A CCE S S
Understanding the Value of
Market Access Insights for
Licensing Deals
Nerea Blanqué-Catalina, Raphaël Metrop, Romain Finas | Alira Health
The term ‘Market Access’ is used to describe the objective to advance the science and practice of
all of the activities necessary to gain health economics and outcomes research (HEOR)
reimbursement for a product in a country. As a around the world. Therefore, market access, pricing
and health economics are related and have grown in
constantly evolving field, it is important to stay
parallel over the years.
updated on the latest trends and tools, and to
understand the value that a thorough market Moreover, around this time, health technology
access analysis can add to an asset, particularly assessment (HTA) agencies began taking form in
when it is being considered in a potential Europe, and they started to look not only at efficacy
licensing transaction. and safety, comparable to regulatory agencies, but at
the cost effectiveness of a technology as well. The
The origin of market access National Institute for Health and Care Excellence
(NICE) was the first agency to appear in the European
The exact date of the origin of market access is Union (EU) back in 19992. Afterward, other HTAs were
unknown. Compared to other pharmaceutical created both within and outside of the EU. Their main
activities, such as marketing or regulatory, market driver is to ensure medicines are affordable for all
access is a relatively young activity. It was borne out patients in order to improve resource allocation.
of the need to understand the relationship between
price, costs and healthcare resources. It can also be We are aware of the past and present status of
linked to the succession of economic crises, as every healthcare; however, it is difficult to predict the future
time there is a major crisis, new cost containment of health systems, healthcare priorities and the
measures are created to keep healthcare costs at bay. resources needed in the mid to long term. This
There are articles that talk about pricing and fair knowledge is quite important in order to understand
pricing in 19981 that show that before the beginning how the pricing and reimbursement landscape is
of the millennia, pharmaceutical pricing was going to develop; how payers are going to reach
becoming an issue. We should consider that The decisions, etc. and, it will be key for companies when
Professional Society for Health Economics and they are making decisions regarding future pipeline
Outcomes Research (ISPOR) was created in 1995 with products, as we will see later on in this article.
References
1
Lu, Z. John and Comanor, William S., (1998), Strategic Pricing Of New Pharmaceuticals, The Review of Economics and
Statistics, 80, issue 1, p. 108-118.
2
Simon Walker, Stephen Palmer, Mark Sculpher, The role of NICE technology appraisal in NHS rationing, British Medical
Bulletin, Volume 81-82, Issue 1, 2007, Pages 51–64, https://doi.org/10.1093/bmb/ldm007
www.plg-uk.com Business Development and Licensing Journal Issue 33 | September 2021
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M A R K E T A CCE S S
Market access and pricing knowledge is constantly • a global launch pricing strategy with
evolving. With the increase in the number of new specific recommendations on price trade-
therapies for rare diseases and genetic treatments, offs and on possible discount agreements
both of which have high prices, economic analyses or innovative pricing agreements with
and new innovative pricing models have been created health authorities; and
in order to ensure the sustainability of the health
system. Therefore, it is important that pharmaceutical • a set of health economic tools that will
companies have market access knowledge, allow payers to understand if a product is
understand payers, and keep up to date with the latest cost-effective, or to demonstrate that a
trends in order to make good business decisions. technology has a positive impact on a
payer’s budget. Cost-effectiveness and
budget impact models are the most
What does market access really mean?
commonly used and well-known, but there
Market Access is often used as a general concept to are many more that can be prepared
describe all the activities necessary to gain depending on the clinical trial design and
reimbursement in a country; these are known as the impact of a product.
market access tools. Market access tools are
prepared with payer input; companies that have these
tools ready before launch are able to optimise the
When to start thinking about market
pricing and reimbursement (P&R) timelines for their access
[drugs/therapies], resulting in improved patient
access to medicines in a given country. The market access discipline has evolved from how it
functioned in the mid-nineties. Experts have learned
The typical set of tools for market access (see Figure that not considering the payer’s view is a strategic
1) includes: mistake as the price of a molecule may not reflect the
assumed price. Our experience is that pharmaceutical
• a global value dossier with specific
companies have learned the hard way that there will
messages that will resonate with payers at be a price to pay if a payer’s view is not taken into
the time of pricing negotiations; account from proof-of-concept and at every stage of
• an objection handler document that has the life of a drug (see Figure 2).
been drafted to answer all possible
questions that payers may ask during price
negotiations;
Figure 1 | The Market Access Set of Tools
www.plg-uk.com Business Development and Licensing Journal Issue 33 | September 2021
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M A R K E T A CCE S S
Figure 2 | List of Market Access Missions Along the Product Development Chain
P&L: the link between market access
and licensing
Profit and Loss (P&L) is defined as the financial That being said, and as detailed in Figure 3 below,
report detailing a company's past, present and future given that market access helps determine the target
ability to generate sales and manage expenses in product profile of the potential licensed asset, which
order to create profits. By nature, this tool allows significantly impacts the design of its development
both a potential licensee and a potential licensor to plan and therefore, the amount of required clinical
clarify the amount of remaining investments required investment as well as the time it needs to be
to make a certain asset, the potential licensed asset, commercially launched, market access insights are
reach the market, and, as well, the expected level of influencing the "L" part of the P&L: the Loss.
revenues, margin and profits this asset will generate
once it is commercialised on a territory-by-territory However, considering that market access also helps
basis. determine the expected reimbursement status and
selling price of the potential licensed asset, both of
The P&L is, therefore, the only way to fully translate a which significantly impact its potential market shares
pharmaceutical development programme into a and related revenues, market access insights are also
return on investment (ROI)-based and financially- influencing the "P" part of the P&L: the Profit.
valuable opportunity. It is the main, not to say the
only, bridge between Research and Development Thus, when it comes to licensing, market access
(R&D), Marketing & Sales and Business Development cannot be ignored!
functions; the reason why its use is deeply connected
to licensing practice.
www.plg-uk.com Business Development and Licensing Journal Issue 33 | September 2021
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M A R K E T A CCE S S
Figure 3 | From Market Access to Licensing Through P&L
Consequences for licensing deals
In every licensing opportunity for an asset that has not yet been launched in the territory of interest, whether
because it is still an R&D-stage candidate, or because it is part of the international development strategy of a
commercial-stage product, the licensed asset needs to be prepared and assessed from a market access and
pricing perspective.
For the future licensor, performing comprehensive market access research is the best way to build a solid and
factual presentation of the asset to be licensed, including an ambitious but still credible business plan reflecting
the payer’s point of view, to raise potential partner interest.
For the potential licensee, adding a market access analysis to the due diligence phase is the best way to justify the
financial terms of the license agreement to be signed, by thoroughly assessing the asset’s ability to generate an
acceptable ROI in the future.
www.plg-uk.com Business Development and Licensing Journal Issue 33 | September 2021
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M A R K E T A CCE S S
Whatever your position on the deal, adding a market demonstration in post-launch studies (from a clinical
access angle to the preparation, presentation, endpoint or health economic perspective).
evaluation, and negotiation of a licensing opportunity,
is essential to reaching success. Pharmaceutical companies have an alternative to
leveraging RWD. They can choose to either access a
A step forward: Real-World Evidence ready-to-use database or generate a fit-for-purpose
source, a decision which depends on the benefits and
(RWE), a mix of big data, market access limitations of each solution.
and digital A ready-to-use database, often accredited by HTA
bodies or the European Medicines Agency (EMA),
Since the 2000s, the use of data generated by the offers better statistical power (66 million patients in
healthcare system (electronic medical records, the Système National des Données de Santé [SNDS]
payers, claims, medical devices, etc.) has become database in France, 60 million patients in the Clinical
instrumental for market access strategies. This so- Practice Research Datalink (CPRD] in the United
called "Real-World Data" (RWD) enriches the value of Kingdom [UK], etc.). However, it brings inevitable
clinical trials with a picture of the practice, outcomes, limitations due to being a predetermined catalogue.
and costs within a daily care routine.
On the other hand, fit-for-purpose sources bring
Depending on the quality, representativity of the data, more flexibility in terms of data choices and a smaller
and reliability of the collection process, Market population scope. Costs remain a critical factor in
Access and HEOR Departments regularly use RWD as decision-making: using existing databases is cheaper
insight for value dossiers (unmet needs, treatment than developing a bespoke data source upfront, which
pattern, burden of the disease, etc.) or the value involves resources to populate a clinical form.
Figure 4 | From Controlled to Real-world Data
www.plg-uk.com Business Development and Licensing Journal Issue 33 | September 2021
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M A R K E T A CCE S S
However, digital and artificial intelligence (AI) is now Conclusion
disrupting the data collection process, offering more
possibilities to customise datasets based on existing It is strongly recommended to perform a systematic
data. AI tools can produce quick reviews of data and full market access and pricing assessment when
available within a hospital, facilitate patient inclusion preparing or assessing a licensing opportunity, taking
and automatise research from a population through into account the payer’s point of view.
textual data structuration.
Furthermore, it is recommended that every Business
Digital adds the patient's voice as well, with new Development & Licensing (BD&L) team obtains basic
digital applications collecting their experience or knowledge of the main market access concepts
continuously monitoring data captured from devices. presented in this paper to ensure they can at least
understand the rationale behind questions,
Managing access to, and co-investing in, real-world suggestions, and feedback from market access
data has become a new competitive advantage for stakeholders during the preparation, presentation,
pharmaceutical companies. It requires a great sense evaluation and negotiations of a licensing deal.
of foresight, and best practice shows that it starts as
early as Phase III. Partnering with HTA bodies to There are new emerging practices that will shape the
validate sources and methodologies becomes key to future, such as RWE. Real-world data, big data,
maximising this new but promising investment area, translated into real-world evidence are a trend in the
Real-World Evidence. pharma industry. Pharmaceutical professionals will
need to get acquainted with the basic concepts of this
practice so they can be up-to-date with our rapidly
evolving industry and can both improve and optimise
decision-making within their companies.
Authors
Nerea Blanqué-Catalina, MPharm, is Vice President of Market Access and Pricing at Alira Health. She has been working in the
pharmaceutical industry for more than 15 years. Prior to joining Alira, Nerea worked at IQVIA, Almirall and Ferrer in global market access and
pricing roles. She has hands-on experience in pricing and market access projects involving global price corridor setting taking into account
external reference pricing and parallel trade, global value dossier design/messages and local adaptations. She has worked in multiple pharma
due diligence projects where she learned the importance of giving the market access perspective in order to reach a successful deal. Nerea
holds a BSc and MSc in Pharmacy from the Universitat de Barcelona, a Research Diploma in immunology from Háskoli Islands, a Postgraduate
Degree in Business Consulting from Glamorgan University in Wales, as well as a Senior Executive Program, PDD from the IESE Business School,
Barcelona. She currently coordinates and gives market access and pricing classes in a Master Degree Program at the Biotechnology Business
institute.
Raphaël Metrop, PharmD, is Partner, Transaction Advisory at Alira Health. He has international experience in corporate and business
development, mainly acquired in the startup environment, and supports management teams, shareholders and investors in the preparation
and execution of M&A, licensing, strategic partnerships and capital-raise projects. Prior to joining Alira Health, Raphaël was Head of Corporate
Business Development at Fab'entech, and Corporate Business Development Manager at Imaxio, now known as Osivax.
Romain Finas is VP of the Real-world Evidence Practice at Alira Health. Together with his team, he offers an integrated approach of Real-
world Data, from data source scouting in Europe, the kick-off and building of new sources to the implementation of regulatory grade real-world
studies. His RWE practice is trained to work on SNDS data and any clinical or machine data. His team comprises experienced and innovative
professionals and supports Alira Health clients to make Real-world Data a competitive advantage.
www.plg-uk.com Business Development and Licensing Journal Issue 33 | September 2021
9
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The Red House, Kingswood Park, Bonsor Drive, Kingswood, Surrey KT20 6AY, UK.LE G A L
Beyond the NDA:
Dealing Effectively with
Confidential Information
Jennifer Pierce | McCarthy Denning
Dealing effectively with confidential In most countries, if information is to be protectable it
must remain secret, so a lack of protection in one
information involves far more than signing
country can affect protection world-wide.
NDAs.
Most of us are used to working in countries which It is therefore crucial to be aware of the legal
provide relatively reliable protection for confidential protection for confidential information so as to avoid
information, which for these purposes includes know- inadvertently making valuable information widely
how and show-how which are confidential and have available. Regrettably, no agreement can make up for
value, as well as trade secrets. many of the deficiencies in local laws, but there are
possible strategies for managing the risks, which are
Enforcing non-disclosure agreements can be explained below.
challenging as it may be difficult to gather evidence of
a breach. There is always a trade-off between the The basic international system under
benefits of disclosure and the risks involved, but we TRIPS
are used to dealing with this.
The World Trade Organisation’s Agreement on Trade-
Furthermore, the world-wide systems for the Related Aspects of Intellectual Property Rights
protection of intellectual property create relative (TRIPS) imposes basic legal requirements in respect of
conformity as regards registered intellectual property confidential information. Under Article 39 of TRIPS,
and copyright, so people come to expect that the legal protection is to be afforded to “undisclosed
protection of all intellectual property and related information” so long as it is:
rights will be similar in other countries.
a) secret in the sense that it is not, as a body or in
It can therefore be a surprise to discover that the the precise configuration and assembly of its
protection available for confidential information in components, generally known among or readily
some other countries, including some with very accessible to persons within the circles that
significant pharmaceutical industries, is far less normally deal with the kind of information in
effective than the protection to which we have become question;
accustomed and this poses significant risks.
b) has commercial value because it is secret; and
If confidential information ceases to be protected in c) has been subject to reasonable steps under the
one country, it can easily become a problem globally circumstances, by the person lawfully in control
in view of the connected world in which we work. of the information, to keep it secret. (Article
39).
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11LE G A L
The theory is therefore that undisclosed information There is some kind of protection for confidential
(which is referred to in this article as confidential information in all of the territories referred to above
information as the term is more common) should be and there is good protection in many. However, the
protected in most of the numerous countries which existence of protection is often less important than
have ratified TRIPS, provided that the information is the effectiveness of that protection; if there are
kept secret and, under the circumstances, reasonable loopholes in protection then it may simply divert
steps have been taken to keep it secret. attention from the risks and create a false sense of
security.
Furthermore, Article 41 of TRIPS provides that:
“Procedures concerning the enforcement of It is also worth noting that the EU surveys, which
intellectual property rights shall be fair and equitable. were to inform the legislators dealing with the Trade
They shall not be unnecessarily complicated or costly, Secrets Directive, showed that there were problems
or entail unreasonable time-limits or unwarranted with enforcement in a considerable number of EU
delays.” countries. Whilst the EU has now legislated, this
shows that the chances of similar problems
There are more detailed provisions in TRIPS, covering elsewhere are unacceptably high.
injunctions, damages (and account of profits), the
disposal of infringing products and the preservation
of evidence. Note that for the purpose of TRIPS
confidential information is treated as intellectual
property.
Some countries ratified TRIPS and provided
protection for confidential information but either
retained measures which detract from that protection
or implemented regimes which are related to: (i) the
enforceability of agreements in respect of the
information in the territory; and/or (ii) exchange
control.
In particular, exchange control, which affects the flow
of money between countries, may (but do not
necessarily) enforce compliance with laws which
weaken protection for confidential information.
Where the system fails in practice
Whilst the author has not conducted a worldwide
survey, she is aware of the position in the UK, EU,
Switzerland, USA, Canada, Mexico, Brazil, Japan,
Singapore, China, India, Russia, Australia, and South
Africa following detailed surveys on their laws of
confidence, which she conducted and which was
published in June this year in Les Nouvelles, the
journal of the Licensing Executives Society
International (see acknowledgement below).
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12LE G A L
It is relatively rare to find a complete absence of
This is a field where
protection in a country, but there may be flaws in the it is vital to examine
basic protection, such as those described below in
respect of Brazil. However, the majority of the
the detail
problems lie in laws relating to implementation, with
a lack of effective enforcement measures or
enforcement regimes which are slow, expensive or
fail to prevent the disclosure of the confidential A know-how licence is therefore treated as a
information in the course of proceedings. A lack of transaction for the sale of the underlying information
evidence of infringement often hinders enforcement, and it is not generally possible to have an enforceable
so if there is little or no assistance with gathering provision for the return of the information. Similarly,
evidence this leads to additional problems. indefinite protection of confidential information is not
permitted. There are also rules which limit the
Whilst TRIPS provides for minimum standards, it does potential payments and other terms under licences.
not attempt the difficult exercise of conforming
national laws, which would assist with cross-border These laws are administered by INPI, the Brazilian
enforcement. In some countries, protection is government’s intellectual property office, where
provided by laws which are specific to confidential details of agreements relating to technical and
information (including statutes and common law), but industrial know-how must be inspected for
in others it may be found in the laws of unfair compliance and recorded. It is also necessary to
competition, tort and criminal law. As a result, there record the agreement with the Brazilian Central Bank.
are different requirements for protection and This mechanism controls the flow of money overseas,
different standards of proof. It is also necessary to thereby ensuring compliance by those outside Brazil.
consider data protection and freedom of information,
labour law, human rights and public interest At the opposite end of the spectrum, in the United
disclosure in many countries. In combination, this States, state and federal laws in respect of trade
variety in laws leads to significant complexity and secrets require that a trade secret owner takes
consequential inefficiencies in cross-border “reasonable measures” or “efforts that are reasonable
enforcement, which may well have contributed to the under the circumstances” to preserve secrecy. This
lack of cross-border cases in the field. reflects the TRIPS requirements mentioned above and
is a common requirement. However, in this case, in
It is also noteworthy that US courts have provided for order to determine whether the trade secret owner
extraterritorial injunctions, which might theoretically has met the criteria, the courts apply the “reasonable
make enforcement simpler in some instances where measures” test on a sliding scale, which results in
the requirements for US protection are met. more stringent requirements for large, sophisticated
However, we have yet to see the extent to which this companies than for start-ups.
form of remedy will be accepted in practice in
territories outside the US which are covered by these Enforcement issues
judgments.
This is a field where it is vital to examine the detail. It
Issues with basic protection is necessary to provide similar remedies to those
available for other forms of intellectual property as
Brazil stands out amongst the more advanced well as the additional requirement to maintain strict
economies as a country where confidential confidentiality throughout the enforcement process.
information is protected but there are material flaws
in the regime for protection as confidential
information is not classified as property in Brazil.
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13LE G A L
A legal regime for effective enforcement needs to If it is necessary to bring both civil and criminal
provide assistance with gathering evidence, actions then there will be two sets of proceedings,
preliminary and permanent injunctions, damages and which adds to the complexity and possibly the length
account of profits. It will also need to protect the of proceedings. This appears to be relatively common
confidential information throughout the proceedings in China and in Russia and may also happen in the
and in any lasting court records, ensuring that United States in certain circumstances.
information which is found to be confidential is
redacted from any judgment. Laws may vary depending on the state or province.
For example, Canada is divided between common law
In addition to the availability of remedies, it is and civil law provinces, where different rules apply.
necessary to know that they are used in practice. For US state laws differ but there is also the possibility of
example, preliminary injunctions, which are crucial to using Federal courts. This also adds to the complexity
ensure that secrecy is maintained pending a full trial and readers should note that the choice of state law
when a more permanent injunction may be granted, for an agreement in the US may affect the outcome in
are notionally available in China but they are rarely the event of a dispute, such as the choice of New York,
granted in practice. In addition, the pre-trial search where certain types of unjust enrichment remedies
procedures are used in few cases. are not available.
It is also necessary to know that the detail of the National laws affecting
legislation has been fully enacted. For example, in
China there is a requirement for a trial court to “take
commercialisation
necessary confidentiality measures in litigation In addition to laws for protection and enforcement, it
activities such as preservation, evidence exchange, is crucial to consider licensing and assignment laws
cross-examination, entrusted appraisal, inquiry and as well as exchange control, which may be separate
court hearings” which are to be on written request or may be linked. As explained above, exchange
from the litigants. However, it transpires that no control can provide a powerful mechanism to ensure
detail has been provided as to what forms of compliance with other laws.
protective order are recommended or even allowed.
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14LE G A L
These laws often apply to other forms of intellectual greater protectionism, so it will be crucial to monitor
property, but they may be especially harsh in the case the extent to which new, protectionist measures are
of confidential information. In particular, these laws imposed.
may:
How to tackle these issues
• effectively prevent a licensor from terminating a
licence of confidential information, as mentioned The basics
above in the case in Brazil; At the risk of stating the obvious, it is crucial to assess
the extent to which a particular deal or project is truly
• limit the amount of royalty or other payments to
dependent on confidential information. It may be that
be made under a licence and the period for
fussing over it will be an unnecessary distraction. If
which payments can be made, as well as other
the work is dependent on confidential information or
licence terms, which also happens in Brazil;
know-how then it is also worth considering whether
• prevent or attach conditions to the licence or any other method of protection is available. For
transfer of rights or certain categories of rights example, there may be biological materials which can
from a jurisdiction, as is the case in South Africa be physically secured even if they do not attract
(all rights) and China (categories of rights). It is, specific legal protection in the relevant jurisdiction.
of course, common to regulate transactions in
defence and security-related technologies as The usual contractual measures need to be in place,
well as transfer pricing, but the exact remit of including well-drafted agreements with all those
those regulations requires careful consideration. working on the project or otherwise receiving
information, and these will include restrictive
There may also be a requirement for registration, as covenants where possible. Information will often be
is the case in both India and Brazil. In particular, disseminated on a need-to-know basis, and all
exchange control can be found in Brazil, China, Japan necessary security will be in place, both physical and
and South Africa. virtual.
New legislation In addition, it is worth considering the partitioning of
facilities and work streams, and possibly the use of
In the course of undertaking the LESI survey, a new more than one facility, provided that this is
law of confidence was enacted in Mexico. Readers operationally viable and does not lead to employment
may be familiar with the EU Trade Secrets Directive of law or regulatory issues. It may also be possible to
2016 and the US Defend Trade Secrets Act from the use actual or figurative watermarks, features which
same year. China has also promised new legislation, are typical of the originator of the information and
which the author understands is not yet in force. which an infringer may not notice or may forget to
remove, as that may help to provide the necessary
The history of intellectual property protection has evidence of misappropriation.
shown that some territories are reluctant to adopt full
protection but they realise the benefits of doing so In some cases, it is relatively difficult to obtain or to
and may therefore adopt half measures, so it is use confidential information effectively without taking
crucial to scrutinise the detail in order to be sure of the related employees, even where the most basic
the actual effect. technology is concerned. It is therefore crucial to
combine effective steps for the protection of
The author has been in lucky enough to see the repeal confidential information with the necessary
of protectionist measures in a number of jurisdictions, employment measures including incentives for
but that was during a spectacular era of free trade. It employees.
appears that we are currently entering a period of
www.plg-uk.com Business Development and Licensing Journal Issue 33 | September 2021
15LE G A L
Beyond the basics
Having dealt with the basics, consider reviewing the Confidential information is the most intangible of all
jurisdictions where the counterparties are located and intangible property so it is easier to imagine that it
the jurisdictions in which information will be disclosed will be stolen; in reality there are many instances
or kept. It may be necessary to limit these by where that very status means that it is more difficult
contract. When these have been ascertained it is to steal.
crucial to take up-to-date legal advice and not to
leave any questions unanswered in that process. A word of warning
If the review suggests a change of territory, that
should be considered. For example, it may be It should now be apparent that the issues described in
possible to retain certain information and processes this article are complex and more especially in an
in territories which are considered safe and then to international context. It is therefore crucial to take
export partially finished products or to export what specialist independent advice in the relevant
are effectively crucial materials. This may sound far- jurisdiction(s) and to ensure that advice is updated as
fetched, but it was clear from the evidence given to necessary. This article, which was deliberately
the EU Commission, during the preparatory work for ambitious in scope, was written to draw attention to
the Trade Secrets Directive, that at least one large those issues, so it should not be used as a substitute
multinational pharmaceutical company makes for detailed legal advice.
decisions on the location of research and
development facilities at least partly on the basis of Acknowledgements
the legal protection for confidential information.
The writer wishes to acknowledge the following
If it is not possible to change territories then consider authors, who contributed to the LESI survey: John
whether a change of deal or project structure would Williamson (Finnegan, Henderson, Farabow, Garrett &
make a difference. For example, does the legislation Dunner, USA), Cȃndida Caffé, Mariana Abenza and
only affect licensing or possibly just intra-group Rodrigo Torres (Dannemann Siemsen, Brazil), Evgeny
transactions? In that case, it may be possible to Alexandrov and Ilya Goryachev (Gorodissky &
change the structure. When changing structure, there Partners, Russia), Dr Mark Horsburgh (Spruson &
will, of course, be other considerations such as tax, Ferguson, Australia), Stéphanie Chuffart-Finsterwald
but this option may be worth considering. (Sigma Legal, Switzerland), François Painchaud,
Amélie Côté and Irina Baldeanu (Robic, Canada), Kei
Iida (Nakamura & Partners, Japan), Qinghong Xu
A positive note (Lung Tin IP Agent, China), Audrey Yap (Yusarn
Despite the obvious challenges, which change over Audrey, Singapore), Dr Madelein Kleyn and Dr Joanne
the passage of time, it has always been possible to van Harmelen (respectively Innovus and ENS Africa,
make good use of confidential information, provided South Africa), Héctor E. Chagoya-Cortes (Mextrategy,
that the necessary care is taken. This is not the only Mexico) and Sudarshan S, Shekhawat and others
area where there are international traps for the (Lakshmikamaran & Sridharan, India) and Anil Dutt
unwary and furthermore, confidential information (Castus Legal, India).
does not constitute the only business risk.
Author
Jennifer Pierce, is a commercial lawyer, specialising in IP, with over 25 years of experience in the field. She advises
on all rights with an emphasis on strategy and transactions. She is best known for her skill in monetising
intellectual property, combining technical legal skills with a knowledge of the licensing business and international
practice. She has been nominated as a licensing expert by Intellectual Asset Management each year since the
directory first appeared as the select IAM 250.
www.plg-uk.com Business Development and Licensing Journal Issue 33 | September 2021
16www.plg-uk.com Business Development and Licensing Journal Issue 33 | September 2021
17R E G UL A T O R Y
Drug-Device Combinations
under the EU Medical Devices
Regulation:
What do pharmaceutical companies need to do
now?
Tasmina Goraya | Taylor Wessing LLP
The EU Medical Devices Regulation (Regulation Integral drug-device combinations are
(EU) 2017/745; "MDR") came into application on primarily regulated under medicines
26 May 2021 and repealed the Medical Devices
legislation
Directive (93/42/EEC; "MDD") and the Active
Implantable Devices Directive (Directive 90/385/ Drug-device combinations falling within the second
EEC; "AIMDD"). sub-paragraphs of Article 1(8) and Article 1(9) of the
MDR are primarily governed by medicinal product
Drug-device combinations sit at the interface between legislation. These are:
medicines and medical devices regulation. The MDR
introduces significant changes for marketing 1. A medical device that incorporates, as an
authorisation holders ("MAHs") and marketing integral part, a substance which, if used
authorisation application ("MAA") applicants, which separately, would be considered a medicinal
may necessitate changes to existing marketing product and the action of the medicinal product
authorisations and pending applications, as well as is principal and not ancillary to the action of the
contracts with medical device manufacturers. device, the integral product is governed by the
medicines legislation (Directive 2001/83/EC or
How these products are regulated, and what Regulation (EC) No 726/2004, as applicable) -
pharmaceutical companies need to do, depends on second paragraph of Article 1(8) of the MDR.
the relative mode of action of the medicinal product
An example of this type of product given by the
vs medical device.
European Medicines Agency ("EMA") is a
medicinal product with an embedded sensor
where the sensor is a medical device and its
action is ancillary to the medicinal product.1
References
1 https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-documentation-medicinal-products-when-
used-medical-device-first-version_en.pdf
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MAA applicants for drug-device combinations falling Device covered by the EU declaration of
within the second sub-paragraphs of Article 1(8) and conformity (e.g. non-sterile or non-
1(9) of the MDR may (depending on the classification measuring class I devices) – the EU
of the device part) need to engage a notified body declaration of conformity should be
designated under the MDR in order to satisfy the updated and provided (if necessary) to
dossier requirements. However, the EMA has said that ensure compliance with the MDR.
notified body certificates under the MDD or AIMDD
that remain valid by virtue of the transitional
Devices covered by an EU certificate under
arrangements in Article 120 of the MDR may be the MDR issued by a notified body – if the
submitted.3 assessment of changes leads to the
issuance of a new or supplemented EU
(b) Products with a pending marketing authorisation certificate, that EU certificate must be
application as at 26 May 2021 provided as part of the appropriate post-
authorisation regulatory procedure.
The amendments to the Medicinal Products Directive
Devices holding a notified body opinion –
by Article 117 of the MDR are not retrospective so the
where the assessment of changes lead to
submission of evidence of compliance with the GSPRs
the issuance of a new notified body
is not required to marketing authorisation
opinion, the new notified body opinion
applications submitted before 26 May 2021.4
must be provided as part of the
However, evidence may need to be submitted if there
appropriate post-authorisation regulatory
is a change to the device part or its intended purpose
procedure.
(see (c) below).
The EMA advises that contractual arrangements with
(c) Products with a granted marketing authorisation
the notified body and the device manufacturer will
as at 26 May 2021
need to address the information obligations and the
Article 117 of the MDR does not apply retrospectively, assessment of the changes. The impact of this is the
but if there is a change to the design or intended MAH or MAA applicant (if not manufacturing the
purpose of the device part, or a new device part is device part) should review their agreements with
introduced, the required declaration of conformity, EU their device manufacturers to ensure there are
certificate or notified body opinion will need to be adequate contractual obligations to ensure these
submitted.5 changes (and supporting documentation) are
communicated by the medical device manufacturer.
A new or updated declaration of conformity, EU
certificate or notified body opinion need to be Other changes impacting the registered information
submitted post-authorisation e.g. as a variation or and/or the quality, safety or efficacy of the product
extension to the marketing authorisation6: will require a variation application to be submitted.
• Where the device part is replaced, or a new (d) Advanced Therapy Medicinal Products
device is added.
Article 117 of the MDR does not apply to advanced
• Where the manufacturer plans to introduce therapy medicinal products (ATMPs). The
changes that might affect the safety or requirements are set out in the ATMP specific
performance of the device part or the conditions guidelines published by the EMA, but to the extent the
prescribed for the intended use of the device ATMP guidelines do not indicate the location of the
part. There are three possible situations where relevant information in the dossier, the EMA's
this could arise: guideline on quality documentation for medicinal
products when used with a medical device applies.
References
3. https://www.ema.europa.eu/en/quality-documentation-medicinal-products-when-used-medical-device
4. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-
devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf
5. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-
devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf
6. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-
devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf
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20R E G UL A T O R Y
Drug-device combinations primarily (a) Co-packaged devices
regulated by the MDR Co-packaged products are where a medicinal product
and a medical device are packed together into a
Two types of devices fall into this category, which are single pack and placed on the market by the MAH.
set out in the first sub-paragraphs of Article 1(8) and
Article 1(9) of the MDR – in broad terms, these are Pharmaceutical companies should be aware that an
devices intended to administer a medicinal product MAH can be deemed to be the manufacturer of the
and those where the medicinal product is ancillary to medical device under Article 16(1) of the MDR and,
the action of the device. thus take on the obligations of a medical device
manufacturer, if it markets the device under its own
1. Administration devices name or trade mark. The exception to this is where
the MAH has entered into an agreement with the
The second paragraph of Article 1(9) of the MDR
medical device manufacturer where it is agreed the
provides that any device which is intended to
medical device manufacturer is identified as such on
administer a medicinal product is governed by the
the label and is responsible for meeting the
MDR, without prejudice to the provisions of Directive
requirements of manufacturers under the MDR.
2001/83/EC or Regulation (EC) No 726/2004 with
regard to the medicinal product.
MAHs would alternatively be considered to be a
distributor of a medical device under the MDR. The
Administration devices can be non-integral drug-
general requirements for distributors is in Article 14
device combinations where they are co-packaged
of the MDR and includes (among other things)
with a medicinal product or referred to in the
verifying that the device has been CE marked and the
summary of product characteristics (SmPC).
EU declaration of conformity has been drawn up and
Examples include oral administration devices (e.g.
is accompanied by the required information, as well
spoons, syringes), injection needles, refillable /
as reporting obligations relating to non-conforming
reusable pens and injectors or inhalers etc.
devices.
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21R E G UL A T O R Y
MAHs or other distributors of co-packaged products the MDR, according to the first paragraph of Article 1
must therefore be aware of their duties as a (8) MDR.
distributor under the MDR and have processes and
systems in place to ensure their obligations can be The notified body must not issue an EU technical
met. Further, contracts with the medical device documentation certificate without first seeking the
manufacturers should reflect these obligations and opinion of one of the competent authorities under
include appropriate contractual safeguards to help Directive 2001/83/EC or the EMA (as appropriate),
ensure compliance both by the MAH and the medical which is addressed further in MDCG 2020-12.
device manufacturer. Agreements between the MAH
and downstream distributors must flow through these Transition arrangements
obligations relating to the device part.
The device part of a drug-device combination product
may have the benefit of the transitional arrangements
in Article 120 of the MDR which allow certain medical
devices CE marked under the MDD or AIMDD to
remain on the market, subject to the following
conditions.
1. Certificates issued by a notified body
The general rule under Article 120(2) of the MDR is
that certificates issued by a notified body in
accordance with the MDD or AIMDD before 25 May
2017 remain valid to the end of the period indicated
on the certificate. There is an exception for
certificates issued in accordance with Annex 4 to the
AIMDD and Annex IV of the MDD, which become void
(b) Referenced medical devices
on 27 May 2022.
Referenced medical devices are those where the
product information (SmPC/package leaflet) of the Certificates issued by a notified body after 25 May
medicinal product refers to a specific medical device, 2017 are also valid up to 5 years from issuance or 27
which the user obtains separately. The reference can May 2024 (whichever is earlier).
be to a brand name and/or a specific description.
Where the device has a valid certificate as described
Additional information that may be required in the above, the device can be placed on the market or put
dossier for the medicinal product (including the into service until 26 May 2024 provided that it
product information) for co-packaged and referenced continues to comply with the requirements of the
products is provided in the EMA's guideline on quality MDD or AIMDD (as applicable) and there are no
documentation for medicinal products when used with significant changes to the design and intended
a medical device. purpose. However, the MDR requirements relating to
post-market surveillance, market surveillance,
2. Medical devices with ancillary medicinal vigilance and registration of economic operators (i.e.
substances the manufacturer, authorised representative,
importer) will apply. The MDR permits these devices
A medical device that incorporates, as an integral that are placed on the market or put into service by
part, a substance which, if used separately, would be 26 May 2024 to continue to be made available on the
considered a medicinal product and the action has an EEA market until 26 May 2025).
action ancillary to that of the device is governed by
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24I N C O NV E R S A TI O N WI TH
In conversation with...
Marco Cerato
Marco Cerato is Executive Vice President, Global Business
Development, Alliance Management and Portfolio
Management at Glenmark Pharmaceuticals. He talks to our
editor, Umaima Ahmad, about starting out in pharma at a
young age, MBAs, restructurings and the impact of inspiring
leadership.
In a white-walled room, with bright sunshine coming formulations (“I was getting so bored in the lab, I
through the windows and an organised set of files couldn’t see the end!,” he tells me frankly), Marco
behind him, I am acquainted with Marco Cerato who moved into Eurand’s Commercial team making his
appears in a crisp white shirt with a pleasant ‘Ciao’ way from an analyst to a strategist.
from Como, Italy where he is stationed during school
holidays, being otherwise based in Cambridge, UK. “Eurand was one of the few companies in Italy that
was working predominantly in B2B, at a time when
After spending his earliest years in Piedmont and CDMOs were not fashionable in Italy.” Eurand floated
subsequently in Brianza, north of Milan, Marco in 2007 on Nasdaq but soon after in 2008, was
completed high school in Colorado in the US, before acquired in a private trade sale by TPG Partners.
graduating and specialising in Biotechnology from “During that time, both my boss Giuseppe Di Vincenzo,
Università degli Studi di Milano-Bicocca on the who was the VP of Global Strategy and Sales, and
northern outskirts of Milan. Keen to make a start on John Fraher, the President and CEO, wanted me to
his career from an early age, Marco started his first work on the integration. McKinsey worked with me on
job in pharma at the age of 22 while his peers were this integration, which was a great experience, and I
still doing exams. ended up moving into BD when we became Aptalis
following a merger with Axcan Pharma.” After
“Usually, when specialising in Industrial spending almost another year at the newly formed
Biotechnologies, students spend two years studying Aptalis, Marco was recruited into Helsinn Healthcare
and taking courses, and one year in the lab doing an in 2011, based in Lugano, in an Italian-speaking
experimental thesis. I decided to cram all of my region of southern Switzerland, to manage emerging
exams into my first year and, instead of spending markets. I point out to him that he seems to select
more time at university in my second year, I went to jobs in very beautiful locations. Marco laughs and
work in a pharma company straight away.” acknowledges his good fortune.
After a year in the lab at Eurand, a company that Around 5 years later, in 2016, Marco stepped up to act
focused on formulation developments such as as Helsinn’s Global Head of Out-Licensing, being
bioavailability enhancements and extended release promoted quickly to Global Head of Business
www.plg-uk.com Business Development and Licensing Journal Issue 33 | September 2021
25I N C ON VE R S A TI O N W I T H
Having the right mentor makes a huge
difference, and so does having the
willingness to go out, be thrown in the
shark-tank and make it happen
Development a few months later. “When I became transformation in the way she was working from
Global Head of BD, I was reporting directly to Andrea beginning to the end. She was a much better
Meoli, CCO of Helsinn, a great guy that I learnt a lot professional by the time she finished.” Still, for Marco,
from.” While I want to talk to Marco about role exercising the muscle by putting the theory into
models, minutes into our conversation, he has already practice in the day-to-day job is what really cements
acknowledged by name several people who have the learning. “The reality is that most of what you
managed him and helped him along the way. I ask him learn, you learn on the job, and those are the
about this. experiences that get imprinted in your head.”
Following seven strong years at Helsinn, Marco
“The important thing in your journey is finding the
moved on to become SVP of Business Development
right mentors. Sure, I found many people that I didn’t
and Strategic Partnerships at Mundipharma, where he
like and from whom I didn’t learn a lot, but I found
covered due diligence, business development and
many more that I did like and from whom I learned a
alliance management. When Mundipharma went into
lot. Having the right mentor makes a huge difference,
restructuring in 2020, Marco was charged with
and so does having the willingness to go out, be
leading one of the biggest restructuring projects in
thrown in the shark-tank and make it happen. I was
relation to emerging markets, systematically
always very fortunate to have the right people
evaluating whether the then-current business model
working with me, teaching me, giving me the right
and portfolio was sustainable on a country-by-
space, so that I could expand my horizons.”
country basis. This resulted in some of Mundipharma’s
global regions moving from a direct-sales model to
Around 3 years in at Helsinn, the company selected a
one relying on third party distributors, with some
few individuals to undertake a fully-funded bespoke
agreements being terminated and a number of
MBA from the Bocconi School of Management. I asked
resources being repurposed. While financial targets
how helpful he found this. “I think MBAs are all about
were met and Marco acknowledges this was “a great
networks, and they can be really useful. In my case
learning experience”, with changes across
though, it was a made-to-measure programme, which
Mundipharma’s senior management leading to a
meant all of the students on my course were from
change in the company’s strategic direction, Marco
Helsinn so, while I expanded my network internally, I
began to look at fresh waters, admitting that he
missed the opportunity to grow my network outside
prefers to “construct rather than deconstruct”.
the company.” As far as the utility of an MBA goes in a
BD role, Marco’s view is that this very much depends
“When Glenmark came along, I was quite sceptical at
on the type of person that you are, what your
first. I knew of Glenmark as a generics company, but
experience has been and whether you are curious by
after a few chats with Robert Crockart (CCO) and
nature. “Working in BD is wonderful because you need
Glenn Saldhana (Chairman and CEO), I really bought
to learn and understand how the whole organisation
into the dream and understood much more about how
works and continuously lead with influence rather
innovation is at the heart of Glenmark.”
than by reporting lines, so you cut across many
departments.” He shares an example of a former
The dream, it transpires, is something not too widely
colleague who had worked for years, learning
known but Marco shares “has always been a passion
everything on the job, but lacked structure. “It was
of Glenn’s”. In 2001, Glenn Saldanha, son of the late
her dream to do an MBA, and so she did it, in her 50s,
company founder Gracias Saldanha, took the helm of
alongside her work, and I could really see the
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