The German regulation of pricing and reimbursement of pharmaceuticals is probably one of the most complicated legal areas in the entire world of life sciences laws. Now, the German government is adding another layer of complexity to the existing rules.

On 20 October 2022, the German Parliament has accepted the draft Act for the Financial Stabilization of the German Statutory Health Insurance System („GKV-FinStG“). The new act was subject to month-long controversial discussions within and outside of the Parliament and affected stakeholders. This was due to the fact that the new rules will affect almost all players within the healthcare system, including the health insurers, doctors, hospitals, pharmacies and, especially, the pharmaceutical industry. The new law encompasses significant cost-containment measures as the German healthcare system faces increased costs while, at the same time, the system suffers from a reduced inflow of funds.

According to the explanatory memorandum of the GKV-FinStG, the cost increase is particularly due to the disproportionate increase of expenditures for medicinal products. Correspondingly, a number of new rules specifically target the pricing and reimbursement of pharmaceuticals. Key elements of the GKV-FinStG that apply to the pharmaceutical industry include the following measures:

  • Changes to the AMNOG market access rules: In the future, the reimbursement price for new medicines agreed in the so-called AMNOG market access process will apply already after the seventh month after product launch – and no longer after twelve months post launch. Hence, this reduces the period during which the pharmaceutical company is free to set its price for a new drug to six months.  
  • The AMNOG process typically ends with an agreement on the reimbursement price of a new medicine. The GKV-FinStG revises the rules governing these agreements. The revised rules especially provide the health insurances with more powers and flexibility. According to the new law’s explanatory memorandum, the German government expects that based on the GKV-FinStG, the reimbursement price negotiations will also consider price-volume components or prescription volume caps in the future. Hence, the system is expected to include more negotiation elements and provide for some more flexibility. 
  • The new rules around the AMNOG reimbursement price agreements also allow for provisions to sanction uneconomic package sizes.
  • Orphan drugs will be subject to stricter rules in the AMNOG system. The pricing and reimbursement of orphan drugs have been a long-standing subject of controversy within the German healthcare system. The sales threshold up to which orphan drugs are partly privileged and only subject to an abbreviated AMNOG process will be lowered. In the future, orphan drugs will be subject to the full AMNOG process if their annual revenue exceeds €30 million (instead of €50 million currently). If the revenue of an orphan drug stays below this threshold amount, the AMNOG system will continue to deem the “additional benefit” of an orphan drug to be established upon its marketing authorization.
  • Combination therapies will become subject to the AMNOG rules and also subject to a new “combination markdown”. Like with the orphan drugs, the expenditures for combination treatments have been a similar hot topic in the German healthcare system. Under the GKV-FinStG, when the Joint Federal Committee (Gemeinsamer Bundesausschuss or “GBA”) determines the “additional benefit” of a new medicine, it will in the future also list the pharmaceuticals that can be used in combination with the new drug. For all drugs with new active substances that are used in such a combination listed by the GBA, the health insurance funds shall receive from the respective pharmaceutical company a markdown payment of 20% of the company’s sales price. The law sets forth a possibility to escape this mandatory 20% markdown payment but that requires that the actual combination has been subject to an AMNOG benefit assessment by the GBA and came out at least with a significant benefit (“beträchtlicher Zusatznutzen”).
  • The German reimbursement laws require a general mandatory markdown payment from all pharmaceutical companies to the statutory health insurances (often also referred to as the “mandatory discount”). This general mandatory discount applies to all medicines and is currently at 7% of the company’s sales price. With the new GKV-FinStG, this mandatory discount will be increased by 5% to 12% for the year 2023. In addition to this general mandatory discount, the specific discounts for generic drugs and the above mentioned mandatory discount for combination therapies (20%) will also apply. Initially, the government had even planned an extraordinary “solidarity contribution” of €2 billion from the pharmaceutical industry. This idea was eventually dropped in the course of the legislative deliberations. Instead of this measure, the 5% increase in the manufacturer’s discount was finally agreed upon.
  • In addition, the mandatory “pharmacy discount” that pharmacies have to pay to the health insurance funds will be increased from €1.77 to €2.00 per Rx-drug package for a period of two years. The new law also requires the pharmacies to contribute to the financial stability of the German healthcare system.
  • Furthermore, a price freeze on medicines has been in effect in Germany since August 2010 (so-called “price moratorium”). This price freeze has always been a very controversial measure but was originally scheduled to expire on 31 December 2022. Now, the GKV-FinStG extends the price freeze until the end of 2026. The GKV-FinStG sets forth a new potential exemption from the price freeze for those medicines that receive a new marketing authorization for either a new indication or a new patient group and promise an improvement of the medical care. Hence, the potential exemption is subject to a  specific qualifiers that the pharmaceutical companies need to demonstrate.
  • Several provisions of the GKV-FinStG also aim to strengthen the local production of medicines in Germany and the EU by, for example, considering this as a factor in the evaluation of the new AMNOG provisions.

As part of the legislation process, now the Federal Council of the German States (Bundesrat) will discuss the adopted draft GKV-FinStG. If the Federal Council has no objections, the GKV-FinStG will be approved by the German President and published in the Federal Gazette to become applicable.

With the new GKV-FinStG, the German drug pricing and reimbursement laws will become even more complicated. For the pharmaceutical industry, the GKV-FinStG will have significant consequences. As the new act leaves a number of questions open and as the GKV-FinStG uses certain qualifiers and criteria that require further legal clarification, pharmaceutical companies should carefully analyse the new laws and their implications for their business and products.

The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”).  On 17 October 2022, the UK Medicines & Healthcare products Regulatory Agency (“MHRA”) published its Guidance on “Software and AI as a Medical Device Change Programme – Roadmap.”  It builds on the Government response to consultation on the future regulation of medical devices in the UK and follows on from the Software and AI as a Medical Device Change Programme, which was published in 2021.  The MHRA has provided deliverables, which map out a course for change to the regulation of this sector.

Aim:

The MHRA’s primary aim is “to protect patients and public whilst ensuring that we accelerate responsible innovation.”  To achieve this, MHRA places emphasis on (A) safety; (B) clarity and streamlined processes (facilitated through guidance and designated standards); and (C) removing friction through a joined up offering for digital health in the UK and strengthening international convergence.

Approach:

At its core, the MHRA’s approach to developing the Roadmap is “patient centred” (noting that AIaMD raises broad questions for society) and highlights need for innovation in this sector to be inclusive across all populations.  The MHRA also wants to support manufacturers and so wants to provide tools to demonstrate conformity (working with BSI to develop standards and tools) and wants to reduce regulatory burdens on industry by driving international consensus.  To achieve this the MHRA intends to update the legislative regulatory framework for SaMD/AIaMD.  However, the majority of changes will be introduced through guidance.  The MHRA highlights that this approach is supported across the government and it has considered related areas of law when developing this framework for medical devices.

Work Packages:

The MHRA sets out a number of work packages (some as standalone packages and others nested within others).  Each package includes (i) a problem statement; (ii) the objectives that breakdown the problem; and (iii) specific deliverables that the MHRA will use to meet the objectives.  We have not covered them in detail but, in summary, these work packages cover:

  • WP 1 Qualification – the MHRA will address the lack of clarity on what qualifies as SaMD and software in a medical device, help manufacturers craft an intended purpose and clarify the concept of “manufacturer” for SaMD.
  • WP 2 Classification – reclassify software so the classification rules are proportionate to the risk.  The MHRA will reform the classification rules, explore the “airlock process” and provide guidance.
  • WP 3 Premarket Requirements – premarket requirements for software will be clarified so the requirements fit software.  The MHRA list six deliverables including reviewing the essential requirements, providing “Best practice” for development and deployment plus providing guidance on a number of topics (retrospective non-interventional studies, joint guidance with the Health Research Authority on governance of research and the importance of human-centered SaMD).
  • WP 4 Post Market – the MHRA highlights that it needs to obtain stronger safety signals for SaMD.  The MHRA will look at adverse incidents for SaMD, change management plus predetermined change control plans/protocols and best practice for expanding the intended purpose of medical devices.
  • WP 5 Cyber Secure Medical Devices – the current regulations do not consider cyber security vulnerabilities.  The MHRA will consider cyber security requirements, management of unsupported software devices (i.e., when manufacturers exit the market) and reporting of vulnerabilities.
  • WP 9 AI RIGOUR – the MHRA notes the lack of clarity on how devices using AI can best meet medical device requirements.  The MHRA intends to develop good machine learning guidance to supplement the good machine learning guiding principles published last year (see our previous blog post here).  Alongside BSI, it will map out and develop standards.  It will also develop best practice guidance and consider experimental work to detect, measure and correct for bias.
  • WP 10 Project Glass Box (Interpretability) – current regulatory requirements do not consider adequately interpretability of AIaMD and the impact this has on safety and efficacy.  The MHRA will develop best practice guidance on “human-centered SaMD” and will produce standards on the development of trustworthy AI.
  • WP 11 – Project Ship of Theseus (Adaptivity) – current systems on the notification and management of change do not fit AIaMD.  The MHRA will thus create guiding principles on adaptivity and change management, explore the concept of “drift” and significant/substantial change and set out proposals for predetermined change control plans for SaMD and AIaMD.

The MHRA intends to publish deliverables in a step-wise manner.  Industry should expect to see the first sub-set of deliverables by the end of this year. 

Comment:

The UK indicated a potential benefit of leaving the EU was that it could develop a world-leading regulatory framework.  However, there has been little in the Government’s response to the Consultation on the future regulation of medical devices in the UK that would make the UK “world-leading.”  Arguably, at best many of the suggested changes merely align the UK with other jurisdictions and at worst add additional regulatory hurdles.  However, the MHRA’s latest announcements suggests that for the SaMD and AIaMD space the UK Government is committed to being world-leading and supporting innovation in a patient centered way.  The MHRA is driving forward the development of practical guidance and standards, the lack of which is often bemoaned by those working in this sector.  However, the MHRA seems alive to the issue of creating frameworks/requirements that add burdens and so is emphasizing its aim to align not only with other areas in the UK (including NICE, CQC and HRA) but also internationally.  This could be an area in which the UK is able to take a leading role in creating a regulatory system to protect patients and promote innovation.

The Medical Device Coordination Group (“MDCG”) has published a new position paper (MDCG 2022-14) acknowledging the significant and urgent lack of capacity of EU notified bodies.  It acknowledges the risk that this could lead to many existing and new medical devices and in vitro diagnostic medical devices (“IVDs”) not undergoing timely conformity assessments under Regulation (EU) 2017/745 (the “MDR”) or Regulation (EU) 2017/746 (the “IVDR”) (together, the “Regulations”)).  In turn, this could mean patients miss out on access to, potentially, lifesaving medical devices and IVDs.  As such, the MDCG has suggested actions for mitigating such challenges.  Importantly, there is a focus on flexibility and pragmatism.

Background

The introduction of the Regulations has meant that many new and existing medical devices and IVDs will need to undergo a conformity assessment by a notified body in the next few years in order to continue to be placed on the market in the EU. Additionally, the Regulations require the re-designation of notified bodies to allow them to conduct conformity assessments under the Regulations. The time-consuming process of such re-designation has led to there being an insufficient number of notified bodies available to conduct conformity assessments under the Regulations.

Thus, a lack of notified body capacity and a large number of devices requiring conformity assessment means there is a risk devices will not be CE marked prior to expiry of applicable transitional provisions, which could result in a disruption to the supply of devices and a significant knock-on impact for patients. 

The MDCG’s latest publication both recognizes and attempts to assuage these concerns by proposing counter-actions aimed to “enhance notified body capacity, access to notified bodies and manufacturers’ preparedness in order to facilitate transition to the MDR and IVDR and to avoid shortage of medical devices”.

This blog post seeks to summarize the MDCG’s recommendations.

Increase notified body capacity

The MDCG makes eleven (11) recommendations that aim to increase notified body capacity.

It advises that notified bodies:

  • use hybrid audits;
  • avoid unnecessary duplication of work (e.g., by leveraging evidence and previous assessment results generated under the prior directives);
  • rationale and streamline internal administrative processes; and
  • be flexible when carrying out “appropriate surveillance” of legacy devices (e.g., by combining audits under the prior directives and the Regulations).

Relevant parties are advised to:

  • foster capacity-building in new and existing notified bodies; and
  • make every effort to speed up the process for designation and notification of conformity assessment bodies.

The MDCG commits to:

  • review its guidance to “eliminate [the] administrative workload” of notified bodies”;
  • explore ways of adding codes to the designation of notified bodies in a timely manner (looking at the depth of assessment and ways to make it faster); and
  • prioritize its own actions aimed at contributing to notified body capacity (including revision of its guidance on the meaning of “personnel employed by the notified body”, MDCG 2019-6 rev. 3).

Additionally, the MDCG calls for the Eudamed framework, which allows machine-to-machine upload of information, to be developed and deployed as soon as possible.

Finally, and importantly, the MDCG clarifies the status of its guidance and how it should be used.  It states:

“As regards the status of MDCG guidance documents, MDCG reminds that their main objective is to assist economic operators, notified bodies and competent authorities to apply the legal requirements in a harmonised way, providing possible solutions endorsed by the MDCG. Having regard to the status of guidance documents, economic operators and notified bodies should be allowed flexibility as to how to demonstrate compliance with legal requirements. Moreover, reasonable time needs to be given to integrate new guidance in the relevant systems and/or to apply them. That means that new guidance should not be applied to ongoing processes or applications already launched by a conformity assessment body for designation and/or a manufacturer for conformity assessment, unless application of such guidance yields increased efficiency of the process.” (emphasis added)

Thus, the MDCG takes a pragmatic approach by indicating that those undergoing assessments under the Regulations should not have to contend with new guidance published after an application has been submitted moving the goal posts mid-assessment.  Rather, new guidance should apply only to subsequent applications.


Increase access to notified bodies

The second category of MDCG suggestions are those focusing on “access to notified bodies”. The first of these emphasizes the obligation of notified bodies to make their standard fees publicly available, to allow manufacturers, particularly SMEs that may have fee concerns, to make informed decisions. The MDCG also suggests that notified bodies develop schemes to allow allocation of capacity for SME manufacturers and first-time applicants, ensuring that such entities have access to the requisite conformity assessments.

Increase preparedness of manufacturers

The MDCG’s position paper also offers suggestions with respect to increasing the preparedness of manufacturers.  The MDCG reiterates its previous advice of ensuring timely compliance with MDR and IVDR requirements (MDCG 2022-11).  However, it notes that notified bodies can support this as the MDCG also encourages “structured dialogues” between notified bodies and manufacturers both before and during the conformity assessment, where these will enhance the efficiency and predictability of the process.

The MDCG recommends that all parties involved in the assessment process increase communication and educational offerings to manufacturers via webinars, workshops, and targeted feedback sessions. The MDCG provides the example of notified bodies working on common application guidelines for manufacturers, alongside national authorities promoting engagement with relevant stakeholders at national level.

Other actions facilitating transition to MDR/IVDR and/or shortage of devices

In its final category of recommendations, the MDCG generally encourages greater pragmatism and a reduction in the complexity of conformity assessments for safe and effective legacy devices (including orphan devices). In pursuit of such, the MDCG proposes:

  • The publication of additional guidance in respect of the practical application of Article 61 MDR (clinical evaluation), and possibly Article 56 IVDR (performance evaluation and clinical evidence), and to make appropriate use of the MDCG’s guidance on clinical evaluation equivalence for legacy devices.
  • The publication of specific guidance (including a definition) on so-called ‘orphan devices’.
  • Encouraging medicines authorities to accept and efficiently process consultations by notified bodies regarding medical devices incorporating ancillary medical substances and companion diagnostics.  In particular, allowing expedited reviews for devices already certified following consultation with a medicines authority under the prior directives.  

The MDCG also notes that it will endeavour to formulate a “coordinated, transparent and coherent approach” in respect of derogations from applicable conformity assessment procedures (i.e., in the interest of public health, patient safety or patient health).

Comment

Although this is merely a position paper, it shows that the MDCG and regulators are acutely aware of the lack of capacity of notified bodies and the impact of the delay in notified body review. Whether these recommendations will lead to any concrete changes is yet to be seen but the recommendations may encourage notified bodies to take a more pragmatic and flexible approach to the conformity assessment of medical devices and IVDs.  This could help manufacturers complete the conformity assessment (and ultimately CE mark their devices) under the Regulations more efficiently. The further guidance that the MDCG indicates is forthcoming is also encouraging.

On 28 September 2022, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) published joint guidelines concerning the use of social media and digital media channels by pharmaceutical companies (Joint Digital Guidelines).  IFPMA  and EFPIA are umbrella trade bodies for the innovative pharmaceutical industry on the global and European stages, respectively.

The Joint Digital Guidelines are timely.  Digital communications and the use of social media have become hot compliance topics for the pharmaceutical industry, both in Europe and globally.  Actors in the healthcare world increasingly use digital communication channels; many clinicians, patients and patient organizations actually prefer to receive content digitally.  With more content comes higher compliance risk.  Digital communications, particularly over social media, can spread fast across borders and are often publicly accessible. 

It is no surprise that a very significant number of pharmaceutical advertising cases in European markets now concern digital channels or social media.  This certainly reflects our experience; and this is an area where our pharmaceutical advertising experts are continually advising clients.

The Joint Digital Guidelines are evolutionary rather than revolutionary.  They represent one of the first attempts to promulgate a set of principles for social media and digital channels that is granular, detailed and has an international outlook.  For the most part, they codify and consolidate existing compliance principles that have permeated the regulatory ether for some time.  Note, however, the focus on influencers and digital opinion leaders, which is to some extent novel.

Although the Joint Digital Guidelines have an international outlook, they clearly take their lead from European concepts and principles.  Much of the detail is based on EFPIA’s European digital guidelines.

The Joint Digital Guidelines are designed to be an “evolving resource” for the pharmaceutical industry when considering their digital and social media activities.  They apply to companies and industry bodies who are member of IFPMA or EFPIA.  By extension, they also apply to companies who are members of national industry bodies and those who submit to the jurisdiction of national self-regulatory bodies. 

The Joint Digital Guidelines are non-binding in nature and intended to be read within the context of existing laws, regulations and codes in this area.  No doubt they will influence the attitudes of national (self-)regulatory and enforcement bodies, which often require companies to operate to a higher compliance standard than required by applicable laws.  

Give the above, we can expect the Joint Digital Guidelines to be influential national level, but it remains unclear and how national approaches may need change.  Some national regulatory or self-regulatory codes have little to no existing guidance on digital activities — and in those cases the Joint Digital Guidelines would presumably become the new benchmark.  In other cases, particularly in the larger European markets such as France and the UK, there is already a significant body of rules and enforcement positions governing digital and social media interactions.  In some areas, thesego further than the IFPMA/EFPIA position.  In those cases, the influence of the Joint Digital Guidelines is harder to predict (at least at this stage).

Structure of the Joint Digital Guidelines

There are five main parts to the Joint Digital Guidelines:

  1. Key Principles
  • This part also sets out the key responsibilities and expectations for a pharmaceutical company engaging in digital communications.
  • Identifying “Allowed” Information: Risk Considerations
  • This part includes a list of questions and risk considerations that a company should ask itself before embarking on a digital communications program.
  • IFPMA Guidance for Various Digital Channels
  • This part comprises detailed guidance for particular media channels (i.e., websites, social media, blogs, podcasts, webinars, direct digital channels such as email, and discussion forums).
  • Specific Guidelines when Engaging with Online Influencers and Digital Opinion Leaders

Some of the content of the Joint Digital Guidelines will be familiar to readers of the EFPIA Code.  Section 2 (Identifying “Allowed” Information: Risk Considerations) and Section 3 (Guidance for Various Digital Channels) borrow heavily — often verbatim — from EFPIA’s European digital guidelines, in Annex 2 of the EFPIA Code.  This perhaps indicates that the European approach has broader international recognition and support; and is something that other industry bodies and national authorities wish to replicate more broadly.

Key takeaways from the Joint Digital Guidelines

The Joint Digital Guidelines are — in some parts — very granular, and a detailed analysis is beyond the scope of this blog (although Covington’s pharmaceutical advertising experts would no doubt delight in giving you chapter and verse — do reach out).  However, below are some noteworthy points:

General Principles

  • IFPMA and EFPIA clearly acknowledge that “any information shared through… social media and digital channels [by or on behalf of pharmaceutical companies] may potentially be accessible from anywhere in the world, which generates risk and uncertainty…”  Also “social media is accessible to the public” and “one of the highest risks when using social media” is “unauthorized promotion [of a prescription-only and/or unapproved medicine] to the public.”
  • Pharmaceutical companies should therefore take a “pragmatic and vigilant” approach to compliance.
  • Companies must not use digital channels to engage in improper promotion and promotional content.  Companies must comply with applicable rules to restrict access to promotional content only to the appropriate audience.
  • Companies who generate or sponsor content on social media or in digital channels (whether promotional or not) must ensure it is truthful, non-misleading, balanced, current and accurate.
  • Companies must be transparent about their involvement with, or influence on, digital or social media communications.  A company’s involvement should be clear from the communication itself.

Responsibilities

  • Companies must establish systems to review and monitor their activities, content, and materials on social media and digital channels.  This includes compliance monitoring e.g., the timely removal of inappropriate comments.  However, there is no expectation to monitor independent third-party content that is beyond the company’s ownership, control or influence (unless local laws or codes expressly require this).
  • Companies’ pharmacovigilance responsibilities will also be relevant to their digital/social media activities, including with respect to their monitoring, record‑keeping and reporting obligations.
  • Companies must ensure that any information on digital channels is up-to-date and clearly displays for each page and/or item the date of posting or last updating.  This is a relatively novel requirement for some countries.

Online Influencers and Digital Opinion Leaders

Perhaps the most novel and interesting aspect of the Joint Digital Guidelines is its commentary on engaging with influencers and digital opinion leaders.  These might include celebrities and social media influencers; but also people who hold particular influence in healthcare fields such as well-known doctors, patients, patient advocates, etc.

According to the Joint Digital Guidelines:

“Engaging with online influencers requires subtle and careful evaluation, including of the risks of undue influence towards HCPs or patients or vulnerable groups, or risks that such digital content could be perceived as improper promotion of pharmaceutical products.”

The Joint Digital Guidelines go on to set out some key principles for these types of engagements.  In particular:

  • Promotional Risks — engaging with influencers cannot be an indirect vehicle to promote products where this would otherwise be unlawful.
  • Undue Influence — the rationale for a company to engage with an influencer or opinion leader should be “considered and documented.”  This is to avoid the perception of impropriety and undue influence (e.g., a reward for past decisions, an incentive to promote, or undue influence over future decisions).
  • Services and Remuneration — the influencer/opinion leader must provide “bona fide services” or those that “serve a legitimate need” and any compensation must be “appropriate and reasonable.”

Traditionally, compliance requirements of this kind apply to company engagements with healthcare professionals or patient groups.  The apparent extension to “influencers” and “digital opinion leaders” most likely reflects areas of current compliance risk and activity.  For pharma compliance geeks like us, this is rather interesting.

Responsibilities for Specific Channels

  • Websites
    • Companies may be held accountable for the content of third-party websites, where the company initiates, influences, selects or provides the content or concept, or where the company pays the authors directly.
  • Similarly, companies must be “confident” about the content of any third-party websites that they link to.
  • Search engine optimization “has become an important tool” to take audiences to the most appropriate content.  However, this must comply with applicable rules.
  • Liability for Employee Social Media Activity
    • This has been a controversial subject in Europe, and the European approach appears to have been extended in the Joint Digital Guidelines.  According to the guidance, pharmaceutical companies may be held responsible for their employees’ social media activities (on personal accounts) “…including a) if the employee can reasonably be perceived as representing the company; and b) if the employee is instructed, approved, or facilitated by the company to do so.”  Companies must therefore provide appropriate compliance training to employees.
  • Webinars
    • A company may be the direct organizer of a webinar; engage a third-party to run a webinar; or simply be a sponsor for third-party webinar.  The company may be liable for the content unless there is a strictly arm’s length arrangement where the company only provides financial support to an independent third-party.

If you have any questions about the Joint Digital Guidelines, their impact, and/or pharmaceutical advertising and communications generally, please do not hesitate to get in touch with one of our many international experts. 

On 1st August 2022, the Italian Competition Authority (“AGCM”) published its decision where it ruled that the NutriScore labelling must be discontinued in Italy because it deceives consumers.  The authority further held that products meant for the French market, where the NutriScore is allowed, and which are distributed also on the Italian market may keep the NutriScore labelling provided that this is sufficiently substantiated.    

Background and Reasoning

The AGCM initiated its investigation in 2021, calling into question the commercial practice of eight distinct companies using the NutriScore labelling on the Italian market.  In its press release announcing the investigation, the AGCM stated that it believed consumers would erroneously perceive the NutriScore as an absolute assessment of the healthiness of a product, whilst the NutriScore does not take into account the overall needs of an individual, including their diet, food intake and lifestyle. 

In its final decision, the authority has maintained this view.  It considers that the NutriScore deceives consumer because it provides “an arbitrary classification of positive foods (fruit, vegetables, fibre and protein) and negative foods (salt, sugar and saturated fat)” but it fails to consider that, for example, proteins are compared without distinguishing their different source (vegetable or animal), fats are not distinguished into monounsaturated and polyunsaturated, and fruit and vegetables are evaluated in the same way as proteins, factors that the authority deems crucial to correctly assess the ‘health impact’ of a food item.

In the AGCM’s view, the NutriScore label does not allow consumers to take informed choices but actually leads them “to believe that, regardless of one’s dietary needs, the green product is preferable over the others in the same product category” and encourages them to consume those green products without limits, on the erroneous assumption that those products cannot have harmful effects on their health. 

Next Steps for Companies

The AGCM decision will have significant direct and indirect implications on food labelling.  In practice, companies that still wish to commercialize their products in Italy with the NutriScore on pack, will be obliged to additionally inform consumers about the nutritional information and dietary context of certain food items by warning them on in-shop posters, shelf tags, their websites, or products’ labelling (even via QR codes) that the NutriScore system is not universally recognized by the scientific community, and that e.g. it does not take into account the needs and nutritional profile of the individual. 

If you have any questions, please contact Giulia Romana Mele or Bart Van Vooren.

On 14 July 2022, the European Commission published a proposal for a Regulation on “substances of human origin” (“SoHO”) intended for human application.  The proposed Regulation is intended to replace the existing and largely outdated Directives on SoHO, respectively on Blood and on Tissues and Cells.  These sets of rules govern the sourcing and use of starting materials for innovative therapies, such as blood, tissues and cells.  Pharmaceutical companies active in the manufacturing of advanced therapy medicinal products (“ATMPs”) are therefore well advised to closely monitor the developments surrounding the proposed Regulation.

The revised legal framework will uphold certain key principles from the existing rules, such as the general principle of voluntary and unpaid donation (although limited compensations for losses related to donor participation are permitted).  EU Member States will also retain full competences on ethical decisions regarding the provision of SoHO-based treatments in their respective healthcare systems.  However, the initiative also proposes a number of important changes to the existing legal framework on SoHO:

  • Harmonized application of rules across the EU: With the proposed Regulation, the European Commission intends to “improve harmonisation, ensuring a uniform level of protection across the EU and simplifying cross-border exchange and access of SoHO therapies”.  To this aim, the Commission will set up a “SoHO Coordination Board”, chaired by the Commission, which will act as an advisory body to support Member States in the uniform implementation of the Regulation (e.g., the SCB is tasked to develop common good practices for inspection and vigilance on SoHO).  With the choice of the legislative instrument, a Regulation, the Commission aims at reducing disparities in the implementation of rules by Member States.  At present, the roll-out of innovative therapies, such as ATMP, throughout EU Member States is hampered by disparities in the implementation of the applicable rules on SoHO.  By harmonizing the rules governing, the sourcing and the use of SoHO, the proposed Regulation is expected to significantly decrease the administrative burden on pharmaceutical companies.  The Commission’s initiative is therefore also a welcome and long overdue instrument to increase access to SoHO-based therapies for patients.
  • Extended scope of application: The proposal extends the scope of the Regulation to any SoHO that are to be applied to humans.  This means, in essence, that the Regulation will also cover substances such as breast milk, intestinal microbiota, and blood preparations that are not used for transfusion.  As an exception, Organs will continue to be regulated separately under Directive 2010/53/EU.  The proposed Regulation aims to provide a legal framework for all the activities to be performed on those substances, from donor recruitment to human application.
  • EU-wide technical standards for the protection of donors, recipients and offspring: SoHO have to be prepared and treated according to specific technical standards to ensure their quality and safety.  Under the proposed Regulation, such standards will be set out either by the European Commission through Implementing Acts or, in their absence, by the European Directorate for the Quality of Medicines & HealthCare (“EDQM”) and the European Centre for Disease Prevention and Control (“ECDC”).  The standards adopted by these expert bodies, which are already widely applied in the sector, will therefore become the main means to meet the EU standards of quality and safety for SoHO.
  • Enhanced self-sufficiency of SoHO supplies: The EU has historically been reliant on other countries for the supply of certain SoHO, such as the United States for plasma used to manufacture plasma-derived medicine.  To counterweight this trend, the proposal lays down provisions meant to ensure EU self-sufficiency and guarantee continuity of supply in case of unforeseen events.  EU Member States will therefore be expected to set up national SoHO emergency plans and alerts for SoHOs that are critically important for patients, in order to anticipate on EU supply interruptions and take timely action to mitigate those risks.
  • New “EU SoHO Platform”: This proposed platform will be developed, hosted, and centrally managed by the European Commission and will be accessible to competent authorities, SoHO entities and establishments (including healthcare providers), patients, donors (and offspring), expert bodies and the Commission.  The platform will allow for the collection and publication of data on donations, clinical use and possible adverse reactions. 

The proposal put forward by the European Commission will now be discussed in parallel by the Council and the European Parliament.  If adopted, the Regulation would come into force after a transition period (set at either 2 or 3 years). If you have any questions on this proposal, please contact Bart Van Vooren.

On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act.  The Sunshine Act entered into force on 26 June 2022.  However, it will become fully enforceable once the Ministry of Health sets up the Public Register where companies will have to disclose their data and issues the necessary implementing acts.  This means that realistically the new transparency system will not be operational before 2023.  Nonetheless, it is critical that companies operating in Italy make sure that they are ready when the time comes.  Here, we outline some of the key features of the new Sunshine Act and the steps that companies could take in preparation.

Main differences with the transparency rules of the industry codes

Prior to the approval of the Sunshine Act, only member companies of trade associations, such as Farmindustria or Confindustria Dispositivi Medici, were under the obligation to disclose the transfers of value made to healthcare professionals (“HCP”) and organizations (“HCO”).  Non-member companies of those trade associations had no corresponding obligation, although many of those companies disclosed their transfers on a voluntary basis, following the provisions of the trade associations’ Codes of Ethics as best practice.

Now, all pharmaceutical companies operating in Italy will be under the obligation to disclose those transfers of value.  In particular, the Sunshine Act applies to any subject which directly or indirectly exercises an activity “aimed at the production or the placing on the market of pharmaceutical products, devices, instruments, goods and services, even of a non-health nature that can be marketed in the context of human and veterinary health”. 

According to the Sunshine Act, companies must report and disclose all their transfers of value, without exclusions.  This means that categories of transfers such as those for promotional materials, meals and medical samples, which are exempted under the industry codes, will also have to be disclosed under the Sunshine Act, provided they exceed a fixed threshold.

Additionally, the industry codes provide for the possibility of disclosing data on transfers in an aggregate form, rather than individually, in two circumstances: when collecting individual consent would not be possible or when the transfer concerns R&D expenses.  The Sunshine Act, however, excludes this option and requires companies to always disclose their transfers on an individual basis.

Transparency obligations under the Sunshine Act: the who, what, when, where and how

Under the Sunshine Act companies operating in Italy that produce or market medicinal products in Italy are in scope of the new transparency obligations.  Arguably, the Sunshine Act has a broad scope of application.  However, it is possible that, for example, a company manufacturing products which are still in the clinical investigation phase would not fall under that definition, as those products could not be considered as produced or placed on the market.

In any event, companies are required to disclose three distinct categories of transfers:

  1. Every semester – Transfers of money, goods, services or other benefits (“ToV”) occurred in the preceding semester and made to: (i) an HCP – when the individual value of the transfer exceeds €100 or the annual overall amount exceeds €1,000; and (ii) an HCO – when the individual value of the transfer exceeds €1,000 or the annual overall amount exceeds €2,500.
  2. Every semester – Agreements with HCP and HCO providing them with direct or indirect benefits “consisting of participation in conferences, training events, committees, commissions, advisory bodies or scientific committees or the establishment of consulting, teaching or research relationships” (“Agreements”) that have been stipulated with them in the preceding semester.
  3. By 31 January of each year – The details of those HCPs and HCOs that (i) holds quotas, shares or bonds in the company (“Shares”), or (ii) received fees from the company for the economic exploitation of their intellectual property licenses (“Licenses”), in the previous year.

Companies must disclose their transfers on a dedicated online database, publicly accessible, that will be set up and managed by the Ministry of Health within 6 months following the entry into force of the Sunshine Act (i.e., by 26 December 2022).  The database will be called “Sanità Trasparente”, will be composed of distinct sections for ToV, Agreements, Shares and Licenses, and will also include a section, equally public, for sanctions imposed on companies that are found in violation of the transparency obligations.  The data stored on the database (with the exception of sanctions) could be freely searched and sorted by the public for at least 5 years following publication. 

Finally, within 3 months from the entry into force of the Sunshine Act, the Ministry of Health in collaboration with the Agency for Digital Italy (AgID), the National Anticorruption Authority (ANAC) and, most importantly, the Italian Data Protection Authority (Garante Privacy), will decide on the structure of the database Sanità Trasparente, including its technical features and the procedure through which companies will submit their data online.  In practice, the system is set to incorporate privacy features by design and by default.

This means that, if the Ministry of Health sets up the database within the proposed timeframe, companies will have to disclose:

  • from the second semester of 2023, the ToV and the Agreements for the first semester of 2023;
  • from 31 January 2024, the Shares and Licenses for the year 2023.

As anticipated, the data that companies will have to disclose on the basis of the above will have to be disclosed exclusively on an individual basis.  To this end, the Sunshine Act establishes that privacy consent is considered provided at the moment when the HCP or HCO accepts the ToV or signs the Agreements or obtains the Shares or the Licenses.  Because the Sunshine Act rejects entirely the disclosure in an aggregate form, the R&D expenses will be disclosed as well on an individual basis and, arguably, with the data on Agreements.

Even though HCP or HCO consent is automatically provided, companies are still under the obligation to inform them of the disclosure by providing them with a privacy notice that must clarify, at a minimum, that their data will be published on the Ministry’s database Sanità Trasparente and their rights to lodge a complaint.

Enforceability of the Sunshine Act

Companies that do not comply with the transparency obligations of the Sunshine Act may incur in severe fines for each of the non-reported transfers.  For example, if a company omits to report a ToV, it may receive a fine of €1,000 increased by 20 times the amount of the non-reported ToV.  Non-complying companies would also face reputational damages.  As a matter of fact, fines also will be made public and freely searchable on the database Sanità Trasparente for at least 90 days following their publication.

Finally, the Sunshine Act provides that every individual may inform the Ministry of Health that a company is violating its transparency obligations.  Indeed, the Sunshine Act establishes that a violation of the transparency obligations constitutes a ground for whistleblowing reports. 

Critical steps that companies could take to get ready

Companies may make use of the transitional time preceding the full implementation of the Sunshine Act to get ready for what is to come.  Here are five steps we suggest companies could take:

Step 1: Review their internal policies, including those on the interactions with HCPs and HCOs and on disclosure of relations with pharmaceutical companies.

Step 2: Review their existing template agreements and implement the necessary changes.

Step 3: Review their privacy notices and draft or amend their existing notices to take into account the information obligation of the Sunshine Act.

Step 4: Establish an internal monitoring mechanism ensuring compliance with the collection and submission obligations of the Sunshine Act.

Step 5: Deliver awareness training to those in charge of the relevant internal functions.

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If you have questions, please contact us.  This article is intended to provide general information about legal developments.  Its content does not constitute legal advice.

The UK government has proposed legislation to open the way for gene‑edited food products in England.  The Genetic Technology (Precision Breeding) Bill (“Precision Breeding Bill”) sets out a new regulatory regime that may provide a faster and easier path to market for certain gene-edited plants, animals and derived products.

Overview of the Precision Breeding Bill

The Precision Breeding Bill applies to “precision bred organisms”.  These are defined in the Precision Breeding Bill as plants and animals that have been genetically modified through the use of “modern biotechnology”, where that genetic modification is of a type that could have been produced using “traditional processes” (i.e. selective breeding, grafting, embryo transfer, spontaneous mutation, etc.).  The definition of “modern biotechnology”, for the purposes of the Precision Breeding Bill, aligns with the set of techniques listed in regulation 5(1)(a) or (b) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (S.I. 2002/2443).  Ultimately, the effect of the Precision Breeding Bill is to create a distinction in law between ‘precision bred organisms’ and all other ‘genetically modified organisms’ (“GMOs”) where the genetic modification could only have been produced using genetic modification technologies (e.g. introducing genes from one species into another, entirely unrelated, species).

The Precision Breeding Bill provides that a person wishing to use precision bred organisms for research or for marketing must first notify and register the precision bred organism.  Once notified and registered for research and development, the precision bred organisms can be released i.e. planted, bred or cultivated.  No specific authorisation is required.  Before marketing the precision bred organism, a person must apply for a ‘precision bred confirmation’, which indicates that the Secretary of State is satisfied, on the basis of information provided by the person, and scientific advice, that the organism qualifies as a precision bred organism.  The UK government will maintain a public register of all notified information. 

The Precision Breeding Bill also provides for an authorisation system for food and feed derived from precision bred organisms.  The UK Food Standards Agency (“FSA”) will have the power to conduct a risk assessment on food and feed derived from precision bred organisms, and recommend that the food and feed receive a marketing authorisation.  The FSA states that “[p]recision bred foods will only be permitted if our risk assessment judges them… not to present a risk to health, not to mislead consumers, and not to be nutritionally disadvantageous.”

The Precision Breeding Bill does not provide for any specific labelling or information requirements for precision bred organisms or products.  The FSA states that it is working on a relevant ‘consumer education project’, although it has not provided details.  

Initially, the government will open the new system to precision bred plants only.  It will not open the system to precision bred animals until it has established “a proportionate regulatory system for precision bred animals to ensure animal welfare is safeguarded”.

Legal and policy background

The Precision Breeding Bill would modify existing UK GMO regulation, which is derived from EU legislation.  The EU legislation provides that an organism is classed as a GMO where its genetic material has been altered in way that does not occur naturally.  It does not distinguish between instances where the genetic modification could have been produced using traditional processes and instances where the genetic modification could only have been produced using genetic modification technologies i.e. EU law does not provide for a separate category of precision bred organisms or similar.

The EU‑derived rules around “contained use” of GMOs (essentially in laboratory settings) are relatively straightforward.  The “deliberate release” GMO rules are more complicated, with complex risk assessments and authorization processes, and strict mandatory traceability and labelling requirements, including for food and feed which contains ingredients produced from GMOs.  Products produced using GMOs must be assessed and authorised on a case-by-case basis before they may be placed on the market. 

The UK government considers that the current, EU-derived “requirement for onerous and expensive authorisation processes for all products of genetic technology has stifled innovation in the UK”.  In contrast, the UK government argue that the Precision Breeding Bill will “cut red tape… [and] remove unnecessary barriers…”.  The proposals in the Precision Breeding Bill are based on advice from the Advisory Committee on Releases to the Environment (“ACRE”).  ACRE argues that the fact that an organism is produced through gene‑editing (or other genetic technologies) does not mean that it necessarily poses a greater safety risk than a traditionally bred or naturally occurring version of that organism.  Rather, ACRE argues, the final characteristics of an organism must be examined to determine whether it presents any safety risks.

Claimed benefits

Defra’s Factsheet on the Precision Breeding Bill claims that the change to the law will bring a number of potential benefits.  The Factsheet notes that precision breeding could enable “the development of crops that are more nutritious, resistant to pests and disease, resilient to climate change and more beneficial to the environment.  This in turn could reduce the need for pesticides, increase food production and reduce costs to English farmers.  Precision breeding can also enhance the health and welfare of animals through greater resistance to diseases and reduced use of antibiotics, and improved resilience to the impacts of climate change.”  The Factsheet also notes that permitting precision breeding “could help facilitate greater trade with countries that currently, or are planning to, make use of precision breeding technologies… [could] enable the creation of potential new export markets for UK-based producers… [and could] also lead to a greater willingness of companies to invest and sell products in the UK relative to the EU due to the creation of a more favourable regulatory environment.”

Territorial application

The territorial scope of the Precision Breeding Bill is limited to England only.  GMOs are regulated by the devolved powers in Wales and Scotland and, currently, neither administration appears willing to follow England’s lead and carve out precision bred organisms from the existing regime.  However, due to the mutual recognition principle in the UK internal market, it will be possible to place food and feed products derived from precision bred organisms on the market in Wales and Scotland, if they can be marketed lawfully in England.  In Northern Ireland, the existing restrictions in EU law on GMOs will continue to apply, and products produced using GMOs must be assessed and authorised on a case-by-case basis.

Timeline

Secretary for the Environment and Conservative MP, George Eustice, sponsored the Genetic Technology (Precision Breeding) Bill (the “Precision Breeding Bill”), and introduced it to the House of Commons on 25 May 2022.  Defra published a full impact assessment on 26 May 2022.  UK Members of Parliament will consider the Precision Breeding Bill again at a second reading on 14 June 2022.  It is not clear when the Precision Breeding Bill will be finalised but it may be before the end of 2022.

Meanwhile, the EU are also reviewing their GMO regime.  The European Commission has opened a public consultation on the regulation of plants produced through certain gene editing techniques, as well as food and feed products derived from those plants.  The consultation will close on 22 July 2022.

In three days’ time (on May 26, 2022), the EU Regulation on In-vitro-Diagnostic Medical Devices (the “IVDR”) becomes applicable in Europe.  But what will this mean for companies who sell in-vitro-diagnostic medical devices (“IVDs”) in the UK?

Following the UK’s exit from the EU, the IVDR will not become effective within Great Britain (i.e., England, Scotland and Wales), but it will apply to Northern Ireland.  Companies operating in both the EU/Northern Ireland and Great Britain will therefore need to be aware of the different obligations applicable to IVDs between these jurisdictions.

IVDR Background

The IVDR will replace the existing EU IVD Directive (the “IVDD”), but will not change the fundamental principles of how IVDs are regulated.  IVDs will be still be subject to a system of self-certification, notified body assessment (in certain instances) and CE marking.  Most notably, under the current system, ~90% of IVDs are self-assessed for conformity and self-certified by the IVD’s manufacturer.  By contrast under the IVDR, the new classification rules mean that this will be flipped to require ~90% of IVDs to be subject to notified body assessment.  This creates practical issues for manufacturers, since there are currently only seven notified bodies who are authorized to conduct conformity assessments under the IVDR.

Continue Reading What do companies supplying IVDs to the UK market need to know about the IVDR?

In collaboration with Corporate Law Group, New Delhi, India 

On December 16, 2021, India proposed amendments to the Biological Diversity Act, 2002 (the “BDA”) by introducing the Biological Diversity (Amendment) Bill, 2021 (the “Bill”).  The process to amend the BDA was undertaken in response to long-standing complaints by stakeholders in the Indian systems of medicine, seeds, and research sectors, as well as industry, that existing access and benefit-sharing (“ABS”) processes in relation to Indian biological resources are too burdensome.

The Bill has several objectives.  It seeks to attract foreign investment in Indian biological resources, to fast-track research, patent application processes, and transfer of research results, and to decriminalize non-compliance.  The Bill also seeks to further the conservation of biological resources in line with objectives of the Convention on Biological Diversity (“CBD”) and Nagoya Protocol to the CBD, to encourage cultivation of medicinal plants, and to support the Indian system of medicines.

The Bill’s proposed amendments are extensive and touch on many different aspects of ABS, but focus mainly on access and access procedures.  In this blog, we present the key proposed amendments, as well as next steps in the process for the adoption of the Bill.

Continue Reading India To Amend Its Biodiversity Rules