Supplementary Protection Certificates (SPCs) are a form of patent term extension right that are available in the EU for medicinal products.

Tune into this episode of Covington’s Life Sciences Audiocast where Inga Pietsch and Roderick Dirkzwager discuss some of the developments in SPC case law from the European Court of Justice in relation to the SPC grant requirement that a product must be protected by a basic patent in force and take a closer look at the Commission’s proposal to update the EU SPC regime to introduce a new unitary SPC.

On October 19, 2023, the World Health Organization (“WHO”) published a set of regulatory considerations on artificial intelligence (“AI”) for health (press release and full publication).  The publication is not guidance or policy but is intended as a resource for relevant stakeholders in medical devices ecosystems, including manufacturers who design and develop AI-embedded medical devices, regulators in the process of identifying approaches to manage and facilitate AI systems, and health practitioners who wish to use medical devices and AI systems in clinical practice.

The WHO recognizes the vital and ever-increasing role AI is playing in healthcare.  However, it highlights the risks that these technologies may pose.  It responds to the growing need to responsibly manage AI health technologies by outlining six areas for governments and regulators to consider when developing and/or updating their legislation and guidance on AI at national or regional levels.

AI in Healthcare

AI has the potential to transform the health sector.  It can improve health outcomes at different stages of healthcare provision.  For example, it can work at an early/preventative stage by encouraging self-care, prevention and wellness.  It can help in research and development by strengthening outcomes of clinical trials.  AI also has the potential to improve the clinical care of patients for example, by personalizing care, improving diagnosis and treatment, enhancing the delivery of care and health system efficiency; and supplementing healthcare professionals’ knowledge, skills and competencies.

Risk and Challenges of AI in Healthcare

The WHO acknowledges that with the rapid deployment of AI, the use of AI technology in healthcare also presents significant challenges.  There may be a lack of understanding of how complex AI technologies work (i.e. the ‘black box’ problem) with a potential for patients to be harmed.  AI technologies, especially those that use machine learning processes, are vulnerable to biases present in the model itself and the training data.   Further, AI technologies used in healthcare often have access to sensitive personal data.  There is therefore a need to effectively safeguard and manage this data, as well as the use for which AI is deployed.   

How to Regulate AI in Healthcare

To manage these risks the WHO outlines six key considerations for the regulation of AI in healthcare:

1. Transparency and Documentation

WHO emphasizes the need for documentation and transparency to build trust in AI systems, as well as developers, manufacturers and end-users.  It recommends that developers of AI technology document the entire product lifecycle, as well as tracking development processes.  Effective documentation and transparency help guard against data biases and manipulation.

2. Risk Management

The WHO also highlights that AI systems used in healthcare may fall into many categories, including AI systems used in medical devices.  WHO recommends taking a holistic risk-based approach throughout the entire product lifecycle, including during pre- and post-market deployment.  It recommends that developers, manufacturers and deployers of AI technology address issues relating to intended use, continuous learning, human interventions, training models and cybersecurity threats. 

3. Intended Use and Analytical and Clinical Validation

WHO highlights the importance of clearly setting out an AI system’s intended use.  Given that AI systems are dependent on the code, training data, setting and user interaction, it is important to describe the relevant use case in order for the system to perform safely and effectively.

Additionally, WHO recommends undertaking the appropriate validation of the AI system.  It recommends that data are externally validated and that it is clear how those data are used.  External validation ensures the quality and safety of input data used in models, minimizing risk to patients.

4. Data Quality

Data is the bedrock of AI systems and there are huge amounts of data in healthcare.  However, the use of poor quality and biased data sets is of significant concern.  WHO recommends the use of rigorous evaluation systems pre-release to ensure data quality.  This should ensure systems do not amplify biases.

5. Privacy and Data Protection

WHO recommends that developers, deployers and manufacturers of AI technology understand the scope and requirements of relevant data protection and privacy laws.  The EU General Data Protection Regulation (“GDPR”) and the U.S. Health Insurance Portability and Accountability Act (“HIPAA”) are of particular relevance.  

6. Engagement and Collaboration

WHO recommends that developers, manufacturers, health-care practitioners, patients, policymakers, regulatory bodies and other stakeholders actively engage and collaborate with each other to improve the safety and quality of AI technologies.  It notes that many regulatory bodies (including the UK Medicines and Healthcare products Regulatory Agency, the European Commission, the U.S. Food and Drug Administration and other international regulators) are already engaging and collaborating on AI.  The WHO considers it fundamental to streamline the oversight process for AI regulation through such engagement and collaboration in order to accelerate practice-changing advances in AI.

What Does This Mean for AI in Healthcare?

The WHO’s publication intends to outline the key principles that governments and regulatory authorities should consider when developing new guidance or adapting existing guidance on AI at a national or regional level.  

The publication picks up on some key themes.  Firstly, the (potential) importance of AI in the healthcare sector.  Secondly, the need to effectively regulate AI to ensure patient safety.  And thirdly, that stakeholders continue to engage and that the community at large works towards shared understanding and mutual learning.  As such, we expect to see more international guidance and principles being published on AI in the short term. 

If you have any queries concerning the material discussed in this client alert or the use of AI in healthcare more broadly, please contact members of our Food, Drug, and Device practice.

Roughly a decade ago, countries such as the USA and France introduced ground-breaking transparency and disclosure legislation under so-called “Sunshine Acts.”  Broadly speaking, such legislation made it mandatory for pharmaceutical companies to publish records of payments or other transfers of value made to healthcare professionals (HCPs) and healthcare organizations (HCOs).

The UK followed a subtly different route, by relying on self-regulatory industry-led disclosure initiatives.  The most prominent of these is Disclosure UK – the disclosure scheme and platform that pharmaceutical companies must use if they are members of the Association of the British Pharmaceutical Industry (ABPI).  Companies who voluntarily adhere to the ABPI Code also use this platform.  However, companies who are neither ABPI members nor voluntarily adhere to the ABPI Code are not subject to the same disclosure or transparency obligations.  Unless they choose to do so under their own initiative, these companies do not publish details of payments or transfers of value to the healthcare community.

This may change soon.  In September 2023, the UK Department of Health and Social Care (DHSC) launched a public consultation, indicating a likely change of approach.  The consultation relates to proposed new legislation, which for the first time in the UK would make it a legal requirement to disclose financial and other benefits flowing from pharmaceutical or medical device companies to HCPs and HCOs.

The proposals consulted upon aim to address potential conflicts of interest in the supply chain, particularly for medical device suppliers, for whom no voluntary or mandatory reporting system is in place.

Significantly Broader Scope

According to the consultation, 145 companies published voluntary transfer of value disclosures on Disclosure UK in 2022.  If implemented, the UK’s healthcare transparency rules will expand this to a much larger scale in two key respects:

  1.  First, the categories of companies who would be subject to mandatory disclosure would be far broader.  Currently, Disclosure UK typically applies to ABPI Members (or voluntary adherents to the ABPI Code).  Generally, these are innovative pharmaceutical companies responsible for the manufacture and/or first supply of branded medicines.  The proposed new legislation widens this significantly to cover suppliers of generic and unbranded medicines, medical devices, so-called “borderline” products, such as some cosmetics, and foods for special medical purposes that are purchased by healthcare systems.
  2. Second, the proposed new disclosure obligations would apply to “every manufacturer and commercial supplier [] as well as their subsidiaries and parent businesses.”  Therefore importers, wholesalers, and other distribution partners may also now be in scope, not just marketing authorization holders or those that promote the relevant products to HCPs.

Why the Changes?

Trust and confidence in the healthcare sector are the main drivers behind the proposals.  The intention is to set a universal reporting standard across much of the healthcare supply chain.  That standard would require medical device and generics suppliers, amongst others, to adhere to similar standards to those currently in place for branded prescription medicines under the ABPI Code.  The broad coverage is considered key to maintaining trust in the system.

The desire to extend this high standard to manufacturers and suppliers of medical devices is a particular priority.  This is responsive to the 2020 Independent Medicines and Medical Devices Safety Review report, led by Baroness Cumberlege, which raised concerns about actual or perceived conflicts of interest relating to payments or payments in kind from device manufacturers to teaching hospitals, research institutions and individuals.

Readers should note that the overarching power to require disclosure already exists under UK law.  The Health and Care Act 2022 empowers the Secretary of State to pass secondary legislation to require the disclosure of payments or benefits to any person either providing healthcare or related to providing healthcare in the UK.

Focus of Consultation

The consultation focuses upon some key questions, including the following:

  1. Is the proposed scope of the reporting requirement appropriate (i.e., companies supplying medicines, devices, and borderline substances)?
  2. What kinds of recipients of payments/benefits are in scope? Does it matter, for example, if a HCP or HCO operates entirely within the private sector?  Should payments to individuals or entities related to healthcare provision, such as those involved in medical research, training, charity arms of hospitals or similar organizations, also be disclosable?
  3. How often should businesses be required to make disclosures?
  4. Currently, the proposal contemplates businesses publishing their payment statistics on their own websites.  The consultation also considers whether companies should instead use approved third-party schemes (such as the ABPI’s Disclosure UK tool).
  5. What information is required to constitute adequate disclosure?
  6. What is the appropriate extent of disclosure for individual recipients, taking into account data protection issues?

Watch this Space

The consultation closed on 16 October 2023 and we expect the outcome to be published in the coming months.

The outcome of the consultation may result in new rules affecting a large number and broad base of healthcare suppliers, including in particular businesses supplying medical devices and medical foods.

Covington will continue to follow developments and provide further updates.

If you would like to discuss the proposals and what they could mean for your company’s operations, please contact: Grant Castle, Robin Blaney, Brian Kelly, Sarah Cowlishaw and Raj Gathani.

On 29 September 2023, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published further guidance (“MHRA Guidance”) on changes to labelling and packaging for medicinal products intended for the UK market (including Northern Ireland) under the Windsor Framework (agreed between the UK and the EU on 27 February 2023, please see our client alert here). 

The MHRA Guidance follows the Agency’s announcement of new labelling and packaging measures in June 2023, which will take effect from 1 January 2025.  The new measures require, amongst other things: (i) medicinal products intended for the UK market to be authorized by the MHRA; (ii) a single UK-wide pack that bears a “UK only” label; and (iii) disapplication of the EU Falsified Medicines Directive 2011/62/EU (“EU FMD”) to UK packs (please see our blog post on this announcement here).

The latest MHRA Guidance provides further detail on the above measures.

Continue Reading New MHRA Guidance on the Windsor Framework: Detail on Labelling and Packaging Changes

On 19 September 2023, the UK  Government announced the launch of the Innovative Devices Access Pathway (“IDAP”) pilot scheme. The UK already has in place an Innovative Licensing and Access Pathway (“ILAP”) for medicines.  IDAP is the equivalent for medical devices, and is groundbreaking in the UK devices space. 

The IDAP scheme aims to improve access to innovative and transformative medical devices, and meet unmet patient needs.  Currently, it is in a pilot phase.  This pilot phase is open to applications from manufacturers seeking to develop and commercialize an innovative device in the UK.  Successful applicants will receive regulatory and market access advice and support at key stages of the development process from “IDAP partners.”  IDAP partners include regulatory and market access bodies such as the Medicines and Healthcare products Regulatory Agency (“MHRA”), National Institute for Health and Care Excellence (“NICE”) and the Department of Health and Social Care (“DHSC”).  The pilot is limited to up to eight innovative devices.  Applications for the pilot phase open on 25 September 2023 and close on 29 October 2023. 

Why apply for the IDAP?

The core aim of IDAP is to provide developers of medical devices with joined-up support that complies with regulatory requirements and accelerates market access to the UK State healthcare system.  In other words, IDAP aims to co-ordinate and accelerate the process by which developers of medical devices can place innovative devices on the UK market and gain reimbursement.

Successful applicants will receive non-financial support from IDAP partners to develop a Target Development Profile (“TDP”) roadmap.

In addition to MHRA, NICE and DHSC, IDAP partners include the Health Technology Wales (“HTW”), National Health Service England (“NHSE”), Office of Life Sciences (“OLS”) and Scottish Health Technologies Group (“SHTG”). 

The TDP roadmap will address specific targets in the regulatory and market access processes for the selected device, including:

  • quality management system support;
  • system navigation advice;
  • a fast-tracked clinical investigation;
  • joint scientific advice with partners;
  • support with Health Technology Assessments (“HTA”) for product realization and adoption;
  • safe-harbour meetings to discuss NHS adoption; and
  • exceptional use authorization granted by the MHRA, provided necessary safety standards are met.

Who is eligible to apply?

Applicants for the pilot scheme must meet (1) general eligibility criteria and (2) pilot criteria.

The eligibility criteria include the following:

  • the product must be a medical device (hardware or software);
  • lead applicants must have a right to market their product in the UK and intend to obtain authorization and market the device in the UK;
  • early-stage products must show proof-of-concept;
  • the applicant must have UK clinical investigation sites lined up and commit to working with IDAP partners to create a TDP roadmap; and
  • the applicant must provide evidence of ISO 13485 compliance (or equivalent). 

Importantly, the product cannot be a drug-device combination product, and applicants cannot be headquartered or operating in jurisdictions subject to UK Government Sanctions.

There are also four IDAP Pilot criteria:

  • Criterion 1: the intended purpose of the device should be for a condition that is life-threatening or seriously debilitating and where there is a significant patient need;
  • Criterion 2: the product must innovative and transformative;
  • Criterion 3: the product will provide system wide benefit; and
  • Criterion 4: the technology clearly helps to address one of the “Life Sciences Vision’s Healthcare Missions.”  These Missions cover a number of priority areas such as neurodegeneration/dementia, early diagnosis/treatment, cardiovascular diseases, respiratory diseases, the underlying biology of ageing and increased understanding of mental health conditions.

There is some overlap between the IDAP pilot criteria and the ILAP criteria.  However, IDAP appears to have more of a focus on sustainability and cost-effectiveness of the devices.  Additionally, the pathways focus on different health issues/missions.

How can applicants apply?

Prospective applicants must submit an application form, which encompasses the following areas: Eligibility, Company Information, Product Details, Regulation and Compliance, the IDAP Pilot Criteria, IDAP Support and Declaration & Submission. 

Applications can be submitted from 25 September 2023 until the deadline of29 October 2023.

A panel will select up to eight medical devices (which must all be at the development and prototyping stage) that it considers most likely to receive the most benefit from the expertise and tools offered in the pilot.  The panel will be made up of representatives from IDAP partners, healthcare professionals and patient representatives. It will notify applicants of its decisions from December 2023.

What is the potential impact of the IDAP?

The IDAP follows a similar pattern to the ILAP for medicines, which accelerates the time to market for certain medicines such as those with new chemical entities, biological medicines, and medicines with new indications or which have been repurposed.  The Government claims the IDAP will provide developers with “an integrated and enhanced regulatory and access pathway”, and the pilot aims to “test the main elements of the pathway” to assist development of the future IDAP structure. 

The launch of the IDAP follows a growing trend by the UK Government to streamline the market approval and market access processes for medical devices.  This has been traditionally more difficult to address for devices than medicines due to a number of factors, such as inclusion of a broad range of products and the fact that regulators do not authorize the pre-market approval of devices.  The UK may become a more attractive place to develop and launch innovative devices as this pathway should help to reduce the time to market and help secure reimbursement for the most promising medical devices, particularly those purporting to meet significant patient need.

Today, the World Intellectual Property Organization (“WIPO”) finished the preparatory session for the draft International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources (the “Instrument”), which will be discussed and adopted at a diplomatic conference in 2024.

At the heart of the Instrument is the introduction of a new disclosure obligation for companies seeking to apply for patents for inventions that are “materially/directly based on” genetic resources (“GRs”) and associated traditional knowledge (“TK”).  Such companies will potentially need to disclose information regarding the source or origin of the GRs and associated TK as part of the patent application.  Failure to do so may lead to the refusal of the patent application.

Attempts to introduce a similar disclosure regime were first made under the TRIPS Agreement in 2008, and then later during the negotiations on the Nagoya Protocol for access and benefit-sharing from GRs, where the introduction of “compliance checkpoints and mandatory transparency disclosure information requirements” was ultimately unsuccessful.  Nevertheless, these type of disclosure obligations have since been introduced under nearly 30 national regimes, such as in India, Spain and Switzerland.  The WIPO Instrument now intends to introduce such a disclosure obligation globally, and potentially, non-compliance may be sanctioned with the possibility of a patent application being refused.

In this blog we summarize some of the key provisions of relevance to companies.

Scope of the new disclosure mechanism

The new disclosure mechanism explicitly covers the following three groups:

  • Genetic Resources” – meaning “any genetic material of actual or potential value.”  This definition is aligned to the one provided in the Convention on Biodiversity (“CBD”), and presumably excludes human genetic resources. 
  • Associated Traditional Knowledge” – currently the Instrument provides three different definitions, placing the accent on the traditional knowledge of the GRs being developed over time by indigenous people(s) and local communities, and where the new invention would not have been possible to create without the use of the TK.
  • GRs obtained in areas beyond national jurisdiction – notably, the new regime could potentially apply also to GRs obtained in areas beyond national jurisdiction, such as marine GRs obtained at the high seas.

One question not addressed by the Instrument is whether it also covers Digital Sequence Information (“DSI”) of GRs.  While “DSI” is not explicitly mentioned in the current draft of the Instrument, older proposed drafts explicitly required that the applicant has access to the “physical samples” of GRs.  However, this text was ultimately removed due to differing views and leaving the question open.  This uncertainty could potentially also be explained by the fact that the Global Mechanism for benefit-sharing from the use of DSI is currently being created after COP 15, and the WIPO may wish to align with the new mechanism and their definition of DSI.

When is the obligation to disclose triggered?

One of the major unsolved issues by the current draft Instrument is the lack of a clear trigger. Due to diverging views by WIPO’s members, the Instrument currently states that the obligation to disclose will be triggered only when the invention is “materially / directly based on” GRs or Associated TK.  This means that the GRs and / or Associated TK must “have been necessary or material to the development of the claimed invention, and that the claimed invention must depend on the specific properties of the GRs and/or Associated TK.”

In essence, this trigger indicates that there must be a causal link between the invention and the GR, meaning information only for those GRs without which the invention could not be made, should be disclosed.  An obvious concern to companies may be the use of research tools, such as animals and plants, yeasts, bacteria, plasmids, and viral vectors  which would be considered GRs.  However, according to the explanatory notes to the draft Instrument, GRs which may be involved in the development of the invention, but which are not material to the claimed invention, should not trigger the disclosure requirement.  This, it states, includes in particular research tools, which are often standard consumables and can be purchased from commercial suppliers. They do not form part of the claimed invention, and therefore need not be disclosed.

Notably, the instrument foresees justifiable exceptions and limitations to the disclosure regime for special cases laid down at national level to protect the public interest.  The text however remains silent and there is no further guidance by way of explanatory note, whether this should cover public health emergencies, thus leaving the issue open whether patent applications for vaccines, therapeutics and diagnostics based on pandemic pathogens will be covered.

What needs to be disclosed?

Once the obligation has been triggered, applicants will need to disclose:

  • either the “country of origin of the GRs” / “the indigenous peoples or local community that provides the Associated TK”; or
  • if this information is not available to the applicant – the “source of the GRs” / “source of the Associate TK”.  

The Instrument defines “Source of the GRs” as:

any source from which the applicant has obtained the GRs, such as a research centre, gene bank, the Multilateral System of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), or any other ex situ collection or depository of GRs (emphasis added),

while “Source of Traditional Knowledge Associated with Genetic Resources” is defined as:

any source from which the applicant has obtained the traditional knowledge associated with genetic resources, such as scientific literature, publicly accessible databases, patent applications and patent publications (emphasis added).

These definitions are very broad and provide a non-exhaustive lists as to from where GRs and associated TK may have been sourced.

If none of this information is available, the applicant may produce a declaration to that effect, which will allow companies to still apply for patents if for justified reasons the relevant information is not known to them.  However, this is an exception and applied in very exceptional circumstances, e.g., the origin of the GRs cannot be identified anymore due to the relevant documents having been destroyed by force majeure.

Once disclosed, patent offices will not have the obligation to verify the authenticity of the information.  However, since this information will be made publicly available in accordance with national patent procedures, and a special “Information system” on GRs and associated TK will be created under the Instrument, such disclosures could still trigger Access and Benefit-Sharing (“ABS”) compliance reviews.

Consequences of a failed disclosure?

The new mechanism poses one crucial question:

Would patents be refused if applicants fail to disclose the required information?

The short answer is – it will depend on the implementation into national law. 

Contracting Parties will put in place “appropriate, effective and proportionate legal, administrative, and /or policy measures”, which could include pre-grant sanctions (e.g., suspending the further processing of a patent application until the disclosure requirement is met, withdrawing/lapsing the application if the applicant fails or refuses to provide the minimum information, etc.) or post-grant sanctions (e.g., fines for wilfully failing to disclose the required information, publication of judicial rulings, etc.).

However, the Instrument at least explicitly states that patents, which have already been granted, cannot be rendered unenforceable solely on the basis of the applicant’s failure to disclose the information, unless the applicant had fraudulently failed to make the disclosure.

Other questions that remain open

There are further aspects of the proposed regime that remain unanswered.  What will be the implication of the patent disclosure formality requirement to the substantive patentability analysis carried out by the patent offices?  One of the underlying objectives of the Instrument is to not grant patents erroneously for inventions that are not novel or inventive with regard to GRs and Associated TKs, thereby improving legal certainty and patent quality.  However how will the information that is disclosed by the applicant be used during the prosecution process? The Instrument provides no guidance beyond the formalities requirements.  The disclosure may though impact on prior art and inventorship/co-inventorship, in particular in jurisdictions where prior art disclosure requirement exist and where correct inventorship can impact patent enforceability.

How confidentiality will be dealt with is another open question.  According to the draft Instrument, the patent office needs to make the disclosed information available in accordance with patent procedures, however this is without prejudice to the protection of confidential information.  It will be interesting to see what justification is required from the patent applicant for the relevant patent office to preserve confidentiality.  Interestingly,  no further discussion of this provision is provided in the draft Instrument.

Next steps

The Instrument will be discussed and potentially adopted at a diplomatic conference in 2024 by all WIPO members.  WIPO has currently 193 members, and, while the European Union, as a single entity, is not a member, each EU member state is a member of WIPO.  Once the text is adopted, it will be open for signatures and enter into force three months after 20 countries have signed it.  

At this stage, it is not expected that the Instrument will have retroactive application, however, given the long duration of research and development needed in some life sciences sectors, companies are advised to consider some measures already at this point.  If you find that the Instrument may affect your business, due diligence activities relating to ABS under the Nagoya Protocol may be helpful.

Covington’s unique practices on Access and Benefit-Sharing from Biodiversity and IP law stand ready to assist you.

On 30 August 2023, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) published detailed guidance on its recently announced new International Reliance Procedure (“IRP”) (see our prior blog and audiocast).  The IRP will apply from 1 January 2024 and will replace and significantly expand on existing EU reliance procedures to apply to authorizations from 7 key international regulators.  As such, the “IRP will allow the MHRA to take into account the expertise and decision-making of trusted regulatory partners for the benefit of UK patients.”  The IRP has obvious implications for a company’s international regulatory filing strategy and will potentially fast-track the approval and access of innovative medicinal products in the UK

What is the IRP?

From 1 January 2024, the European Commission (“EC”) Decision Reliance Procedure will be replaced by, and the Mutual Recognition/Decentralized Reliance Procedure rolled-up into, the new IRP.  The IRP is a new procedure that will allow medicinal products approved in other jurisdictions that meet certain criteria to undergo a fast-tracked MHRA review to obtain and/or update a marketing authorization (“MA)” in the UK or GB. 

Applicants that have received an authorization for the “same product[1] from one of the following specified international “Reference Regulators” (“RRs”) can use the IRP:  

  • Therapeutic Goods Administration (“TGA”) (Australia)
  • Health Canada (Canada)
  • Swiss Medic (Switzerland)
  • Health Science Authority Singapore (“HSA”) (Singapore)
  • Pharmaceuticals and Medical Devices Agency (“PMDA”) (Japan)
  • Food and Drug Administration (“FDA”)
  • European Medicines Agency (“EMA”) and national competent authorities (European Union).

The UK, Australia, Canada, Singapore and Switzerland participate in an “Access Consortium,” which share work during scientific advice and application processes.  Access Consortium approvals that did not include the MHRA can also be used in the IRP.

The RR authorization must be based on a full and standalone assessment of the relevant medicinal product to support the IRP.  However, conditional and exceptional circumstances MAs (or international equivalents) can support IRP applications.

What types of MAAs can applicants submit under the IRP?

The IRP is broad in scope; applicants can submit the following types of marketing authorization applications (“MAAs”):

  • new active substances and known active substances;
  • generic applications;
  • hybrid applications;
  • biosimilar applications;
  • new fixed combination product applications

The IRP is also not limited to initial MAAs.  The procedure can be used throughout the lifecycle of a product for post-authorisation procedures including line extensions, variations and renewals.  An applicant also has the flexibility to obtain an initial MA using the IRP and then use national post-authorization procedures. 

Excluded from the scope of the IRP are:  bibliographic applications; traditional herbal registrations; homoeopathic registrations (Simplified Registration Scheme); and homeopathic national rules authorisations (National Rules Scheme).

How long will the IRP take?

There are two mutually exclusive Recognition Routes in the IRP applicable to initial MAAs:

  • Recognition A is a 60-day timetable with no clock-stops.  To use this route the RR approval must have been granted in the last two years, the manufacturing process must be the same as approved by the RR and there must be evidence of GMP compliance.  Also, the application must not meet any criteria of Recognition B.  If there are any unresolved major objection at day 60, the timetable may revert to Recognition B.
  • Recognition B is a 110-day timetable.  It has one clock-stop at day 70.  If there are any major objections that are unresolved at 110-days, then the application will revert to the standard MHRA 210-day timetable.   Recognition B applies if the RR approval was granted in the last 10 years and the IRP application meets any one of the listed 24 criteria in the MHRA guidance.  These include, for example: that the RR granted a conditional or exceptional circumstances MA (or equivalent); the applicant is seeking a conditional or exceptional circumstances MA in the UK/GB; the product contains a first-in-class new active substance; the pivotal clinical data are from single arm studies and/or including real world data; and/or where an IVD is required for correct use, the IVD is not CE/UKCA marked.

The guidance also highlights that certain products will only be eligible for Recognition Route B, including: orphan medicinal products, advanced therapy medicinal products, products where the Environmental Risk Assessment has not been assessed by the RR, products where any manufacturing site is a new site (i.e., not reviewed by the RR) and fractionated plasma products.  These align with the listed Recognition B criteria.

Are there any Applicant eligibility criteria?

An applicant using the IRP must be established in the UK or EU/EEA and should be the same company or part of the same group as the holder of the authorization obtained from the RR.  The MHRA will allow a third party, where written assurance is provided that they can meet the requisite legal obligations. 

Six weeks before the intended submission date, an applicant should submit an online eligibility form to confirm suitability for Recognition Route A or B.  This form should be submitted with the dossier.  Applicants should submit their applications via the MHRA’s online Human Medicines Portal.  The MHRA’s guidance details the documentation that has to be included, including a cover letter and the mandatory documents for each RR.

Are there any additional UK-specific requirements?

A medicinal product subject to an IRP application must satisfy the definition of a medicinal under the UK’s Human Medicines Regulations 2012.  Additionally, generic and biosimilar applications must be consistent with the UK Reference Product’s indication and posology.  However, applicants should refer to the MHRA’s guidance on comparator products in bioequivalence and therapeutic equivalence studies, if the comparator was not sourced from the UK/EU/EEA.

Applicants also need to comply with UK-specific requirements, for example, requirements relating to UK paediatric requirements, risk management plans, nitrosamine risk assessments, compliance with British Pharmacopoeia or European Pharmacopoeia monographs (unless justified) and having an Active Substance Master File if full information on the active substance is not otherwise included in Module 3.

In addition, generic and hybrid MAs that use comparator products sourced outside of the UK/EU/EEA can only obtain a UKMA(GB) until new provisions of the Windsor Framework concerning medicinal products take effect on 1 January 2025.

Will the IRP apply in Northern Ireland?

The IRP will apply for Northern Ireland.  Currently, pursuant to the Windsor Framework products that have an EU central authorization can only be authorized in Great Britain (i.e., obtain a UKMA(GB), which is only valid in Great Britain).  Once new provisions of the Windsor Framework concerning medicines take effect on 1 January 2025, recognition of an EU MA would result in an MA valid throughout the UK.

[1] “Same product” is defined as products having “the same qualitative and quantitative composition (active substance(s) and excipients), and the same pharmaceutical form, from Applicants belonging to the same company or group of companies or which are ‘licensees’.”

Orphan drugs have a special position under EU pharma laws. Among other things, the EU orphan drug laws grant the marketing authorization holder (MAH) of an orphan drug a 10 year period of so-called “market exclusivity”. According to Article 8(1) of the Regulation (EC) No. 141/2000 on orphan medicinal products, the EU and the EU Member States “shall not, for a period of 10 years, accept another application for a marketing authorization, or grant a marketing authorization or accept an application to extend an existing marketing authorization, for the same therapeutic indication, in respect of a similar medicinal product.” This market exclusivity is a particular incentive granted to pharmaceutical companies that develop orphan drugs.

Now, the Munich Regional Court (Landgericht München I) has decided on 4 August 2023 in a German civil litigation case (case-no.: 21 O 6235/23) that this market exclusivity right also gives the MAH of the orphan drug the subjective right to enforce the market exclusivity also against competitor companies before civil courts. Hence, the enforcement of the market exclusivity is not limited to legal actions against regulatory authorities. As far as we know, this is the first court judgment that confirms this legal position in this area.

The Munich court has also drawn interesting conclusions on the scope and nature of the underlying violation and infringement of the market exclusivity (see below).

This court decision has an interesting case pattern and will probably have a wider impact. The decision was taken in a preliminary injunction case. So, what happened?

Case Facts

Pharma company A. has been marketing the orphan drug S. with four approved indications. Three of these indications still benefit from orphan drug market exclusivity in the EU while this exclusivity has expired for the fourth indication (paroxysmal nocturnal haemoglobinuria or PNH). In April 2023, the competitor company B. received the marketing authorization for a new biosimilar medicinal product for the indication PNH but not for the other three indications of the orphan drug S. Nevertheless, company A. filed a civil action against company B. due to concerns against the promotion of that biosimilar. These concerns were caused by the fact that B. has distributed a (promotional) recommendation letter which included references to a cross-indication use of the biosimilar drug, i.e. a use of the biosimilar also in the three indications that are still under market exclusivity for orphan drug S. This is also referred to as “cross-label use”. Company A. took the position in the court proceedings that this promotional activity can encourage doctors to prescribe the biosimilar for such a cross-label use. Accordingly, A. argued that by doing so, the competitor B. is violating the market exclusivity of drug S. for the remaining three indication.

Already in May 2023, company A. could successfully obtain a preliminary injunction from the Munich Court in which the court ordered that company B. has to cease and desist from distributing its biosimilar product without taking specific accompanying measures that are suitable to protect the remaining orphan drug market exclusivity of drug S. The preliminary injunction was appealed by B. and now, on 4 August 2023, the Munich court issued the said judgment.

Legal Findings of the Court

The Munich court largely upholds its original legal decision. It emphasized that the market exclusivity for orphan drugs also gives an absolute subjective right to the MAH who can enforce this also against competitors before civil courts. The defending company B. had taken the position that the Orphan Drug Regulation only has an impact under public law and prohibits the regulatory agencies to authorize a competitor product but that the regulation does not grant the MAH a claim under civil law against competitors. The court disagreed with this argumentation.

The Munich court stated that the market exclusivity right in its subjective meaning is intended to grant protection against impairments or infringements of the market exclusivity also against other competitors. According to the court’s understanding, the legislator’s intention regarding the market exclusivity right was to create a legal position for the MAH that goes beyond the mere public law rights against regulatory agencies. The court stresses that under the Orphan Drug Regulation, the market exclusivity right is the decisive incentive for companies to invest in the field of orphan drugs and that this is only possible if the MAH is given the legal possibility to take individual action against circumvention or infringements of its rights, even after marketing authorization has been granted.

Furthermore, the court confirmed that such a violation of the market exclusivity of an orphan drug can also be committed if a competitor distributes promotional material that suggests a use of his product in an indication that still enjoys market exclusivity. This aspect is also interesting, since Article 8 of the Orphan Drug Regulation (EC) No. 141/2000 does not explicitly mention the possibility of infringement of the market exclusivity through advertising activities by a competitor.

Practical Implications of the Decision

In its press release, the Munich court reports that the competitor B. has meanwhile decided to withdraw the biosimilar product from the German market.

This new court decision clearly strengthens the position of pharmaceutical companies with orphan drugs. The decision generally strengthens the legal status of the orphan drug market exclusivity. With respect to the EU pharmaceutical rules, the German courts have traditionally been rather reluctant with deriving an own subjective right for granting pharmaceutical companies to take own legal action or go after competitor companies in litigation.

This has also been a chronic issue in Germany in the generics area where complaints of MAHs of originator reference products have been rejected on the ground that they do not enjoy an individual subjective right to challenge a generic authorization. On that issue, the Court of Justice of the EU (CJEU) had decided in the Olainfarm case in 2014 (Case C-104/13) that EU law grants legal standing for MAHs of reference products against a generic authorization on the basis of their data exclusivity rights and had broadened the concept of subjective public rights of MAHs under Directive 2001/83/EC (see our E-Alert on the Olainfarm case of the CJEU).

This new Munich court decision also underscores the importance of a careful legal review of promotional material and its implications in the market.

This decision of the Munich court is subject to appeal and may not be the last word in this case. It will also be interesting to see how other courts in Germany and the EU will handle such cases. Therefore, pharmaceutical companies and stakeholders should closely monitor the legal developments. The Life Sciences Team of Covington & Burling LLP in Frankfurt (Germany) will continue to monitor the situation and report about further developments.


Big news for manufacturers: the UK Government announced on 1 August 2023 that it will indefinitely recognize the EU’s product conformity assessment mark (the “Conformité Européenne” or “CE” mark), with respect to a range of manufactured goods placed on the UK market. 

The move is a significant reversal of the UK’s previous, post‑Brexit policy.  In a bid to separate the UK’s internal market from the European market, the UK promised to phase out CE marks for products marketed in England, Scotland and Wales (Great Britain or “GB”), and replace them with an equivalent “UKCA” mark.  However, the project suffered from numerous delays, and the UK repeatedly extended the deadline for transitioning from the CE mark to the UKCA mark, before the recent announcement that the UK will accept CE marks indefinitely.  Despite this change of policy, the UK has not abandoned the UKCA mark yet, and manufacturers may still choose to use it.  Even so, it is not obvious why a manufacturer would choose conformity assessment that is recognized only in the UK over (or even as well as) conformity assessment that is recognized across the UK and the EU.  What remains to be seen is whether differences between the UK and EU conformity assessment standards will lead to a kind of “forum shopping” by manufacturers. 

Also, and of significant importance for medical device manufacturers, the indefinite extension of CE mark recognition does not (at least currently) cover medical devices nor in vitro diagnostic medical devices (“IVDs”).  The Medicines and Healthcare products Regulatory Agency (“MHRA”) is separately consulting on international recognition of foreign approvals (including CE marks) in the medical device space.

Continue Reading UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)

Germany’s hospital system is reported to be of high quality but is also very expensive by international standards. Hospitals and healthcare payers such as health insurances are exposed to increasing economic constraints. One particular point of criticism is, for example, the current system of Diagnosis Related Group (DRG)-based fees.

Patient treatments are compensated based on the DRGs which effectively leads to a lump-sum payment system per diagnosis (with certain exemptions). This system has pros and cons. As a downside, it is reported to create incentives for over-treatments to generate DRG-based fees per patient.

At the same time, many hospitals in Germany are at risk of closure and insolvency due to financial challenges. The German federal states have thus asked the federal government for financial support to finance the restructuring of the hospital system and prevent hospitals from bankruptcy.

Continue Reading Germany plans significant hospital reform with broad impact on life sciences companies