Tune into this episode of Covington’s Life Sciences Audiocast, where Winsome Cheung and George Jenkins discuss the key trends in Life Sciences Transactions for 2024. The speakers discuss the outlook for deal-making in Life Sciences and predictions for deal trends, including in relation to nuclear medicine, GLP-1, antibody-drug conjugates and other modalities. The speakers also discuss some of the key legal considerations that are coming into increasing focus for Life Sciences Transactions, such as competition/antitrust considerations and the Inflation Reduction Act. This is the first Life Sciences Transactions audiocast for 2024, and we plan to release further audiocasts over the course of this year that dive deeper into some of the above topics.

The European Union has adopted various new rules for emergency situations relating to public health.  These new measures build on the experience gained from the COVID-19 pandemic and give new powers to the European Commission, in close cooperation with the Member States. 

The new rules create a complex public health crisis management system.  Measures that may be adopted under this system can be far-reaching.  They include supply chain monitoring, information requests, and sometimes direct intervention of authorities in production and distribution of critical products.  The primary aim of the new rules is to ensure availability and supply of these critical products in times of crises.

This blog briefly discusses the impact of the health emergency measures on medical devices.

Background

Based on the experience with the past pandemic, the EU has adopted several regulations aimed at tackling future public health emergencies, namely:

  • Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency (“EMA”) in crisis preparedness and management for medicinal products and medical devices (“Regulation 2022/123”).
  • Regulation (EU) 2022/2371 on serious cross-border threats to health (“Regulation 2022/2371”).
  • Council Regulation (EU) 2022/2372 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level (“Regulation 2022/2372”).

The Commission has also published a proposal for a Regulation on compulsory licensing for crisis management, which is currently going through the EU legislative procedure.  The Commission proposal for a Single Market Emergency Instrument, which does not relate specifically to health but indirectly impacts medical devices, is also going through the EU legislative process (see our blog on this topic here).

Impact of each Regulation on Medical Devices

a. Regulation on Reinforced Role for EMA

Regulation 2022/123 provides a framework for managing the impact of public health emergencies and major events, and assigns new tasks to the EMA, including monitoring, preventing and reporting shortages of medicines and medical devices.  The Regulation became applicable on 1 March 2022 for medicines and on 2 February 2023 for shortages of critical medical devices.  In respect of the latter, the Regulation established within the EMA the Executive Steering Group on Shortages of Medical Devices (“MDSSG”) to coordinate urgent actions within the Union in relation to the management of supply of critical medical devices and in vitro diagnostic medical devices in the case of a public health emergency. 

Following the recognition of a public health emergency, Regulation 2022/123 sets out certain measures that will impact medical devices:

  • The MDSSG must adopt and publish a list of categories of medical devices which it considers to be critical during the public health emergency.  MDSSG will gather information on those medical devices through EUDAMED, but also directly from importers, distributors, and national databases.
  • The MDSSG must then monitor supply and demand with a view to identifying shortages of critical medical devices. 
  • The MDSSG must also regularly report the information it gathers under the previous two points to the Commission and to Member States and make recommendations on approach to manage (potential) shortages of critical devices.
  • To facilitate the information collection detailed above, the EMA may request information from manufacturers of critical medical devices, authorised representatives, importers, distributors, and notified bodies.  Relevant economic operators will also have an obligation to proactively report information on shortages to the EMA.
  • The Commission, taking into account the MDSSG’s recommendations, must take all necessary action with a view to mitigating actual or potential shortages of medical devices included on the public health emergency critical devices list.  The Commission will be empowered to do this in a number of ways, including through adopting guidelines for Member States and liaising with third countries and international organizations.

b. Regulation on Serious Cross-Border Threats to Health

Regulation 2022/2371 entered into force on 26 December 2022.  It lays down rules for the surveillance, preparedness, response planning, and emergency research related to cross-border threats to health.  This Regulation repeals and replaces the previous Decision 1082/2013/EU.  In this framework, it addresses EU-Member States joint procurement for medical countermeasures (including medical devices) and provides that the Commission and Member States may engage, as contracting parties, in a joint procurement procedure. 

The Commission will take a central role in this process and will ensure coordination and exchange of information between parties, compliance with procurement procedures (including in particular the EU Financial Regulation (EU) 2018/1046), and execution of the procurement.  This could include development, stockpiling, distribution, and donation of medical countermeasures.  Importantly, Regulation 2022/2371 also permits the advance purchase of medical countermeasures in anticipation of a potential serious cross-border threat to health.  

c. Regulation on Supply of Crisis-relevant Medical Countermeasures

Regulation 2022/2372 establishes a framework of measures for ensuring the supply of crisis-relevant medical countermeasures (including medical devices) in the event that a public health emergency at Union level has been established.  It creates the Health Crisis Board to coordinate the implementation of measures adopted under the Regulation.

In the event of a public health emergency, Regulation 2022/2372 grants power to the Council to adopt, upon proposal of the Commission, a regulation activating the emergency framework and setting out appropriate measures to handle the situation.  There are five measures that could impact medical devices:

  • Monitoring: the Commission will monitor the supply and demand of crisis-relevant medical countermeasures, including medical devices: their production capacity, stockpiles, possible supply chain disruptions and purchasing agreements.
  • Procurement and manufacturing: the Health Crisis Board will advise the Commission on appropriate ways to procure crisis-relevant countermeasures, including medical devices (e.g., through existing contracts, or through Regulation 2022/2371).  In case of shortage, the Commission has power to help increase the availability of crisis-relevant medical countermeasures. 
  • Inventory of production and production facilities: the Commission may request manufacturers of crisis-relevant countermeasures, including medical devices, to inform on their production capacity and existing stocks, in the EU or in third countries.  The requested information may also include a schedule of production plans for the next three months.
  • Inventory of crisis-relevant medical devices: where it considered that there is a risk of shortage of medical devices, the Commission may request that manufacturers share an inventory of those medical devices.
  • Measures to ensure availability and supply: where it considers that there is a risk of shortage for medical countermeasures, including medical devices, the Commission may adopt measures to increase their availability (i.e., reorganize supply chains and utilise existing stocks).  In doing so, the Commission will have to act in coordination with concerned Member States and economic operators.  Potential measures include: (i) Facilitating the creation, expansion or repurposing of production capacities; (ii) Implementing procurement initiatives, reserving stockpiles; (iii) Facilitating the licensing of intellectual property and know-how.

d. Commission Proposal for a Regulation on Compulsory Licensing for Crisis-management

On 27 April 2023, the Commission proposed to establish a Union compulsory licensing of certain intellectual property rights in force in one or more Member States: patents (including published patent applications), utility models, or supplementary protection certificates. 

According to the proposal, the Commission may grant a Union compulsory license if an emergency or crisis instrument has been activated (e.g., if a public health emergency is recognized under Regulation 2022/2371, or where the emergency framework under Regulation 2022/2372 is activated).  If granted, the Union compulsory license would be limited to “crisis-relevant products” which could include medical devices.

The proposal is going through the legislative procedure.  On 13 March 2024, the European Parliament adopted a series of amendments (accessible here).  The Council has not yet adopted its position.

Conclusion

Regulations adopted in the wake of the COVID-19 pandemic create a complex public health crisis management system.  For medical devices, the primary aim of these Regulations is to ensure their availability and supply in times of crises.  To that end, new powers have been granted to the Commission, and new bodies have been created to monitor and oversee issues that could impact the supply of medical devices and in vitro diagnostic medical devices to the EU market. 

Measures that may be adopted under this new coordinated system could potentially be far-reaching.  They include supply chain monitoring, information requests, and sometimes direct intervention of authorities in production and distribution of medical devices.  It is difficult to predict how it will work in practice because its implementation has not yet been tested. 

Nevertheless, a possible future activation of this public health crisis management system is very likely to impact medical devices.  To anticipate measures under these Regulations, it will be important for companies to pay attention to the work of the Commission and newly created bodies as they monitor the market and report on its situation.

It is in any event reassuring to know that European institutions and regulatory agencies are committed to implementing a coordinated approach to manage shortages of critical products in the event of future pandemics or health emergencies. 

If you have any queries concerning the material discussed in this blog or medical devices more broadly, please contact members of our Food, Drug, and Device practice.

The High Court has quashed decisions by the Food Standard Agencies in England, Wales and Scotland (“the FSAs”) that concluded that monk fruit decoctions are a novel food.  The Court ordered the FSAs to re-consider their position by assessing all of the evidence submitted to the FSAs on its own merits, rather than the FSAs’ previous approach of rigidly applying (non‑binding) European Union guidance.  The judgment is available here.  This case is the first of its kind in Great Britain and is relevant for individuals and companies considering whether or not their foods or food ingredients are novel under the GB novel food regime, which requires evidence of significant consumption of a food prior to 1 May 1997 to conclude the food is “non‑novel”, and not requiring a novel food approval. 

Continue Reading Food Standard Agencies in Great Britain unlawfully classified monk fruit as novel, High Court rules

On March 11, 2023, the UK Government published its response (“Government Response”) to an independent review on equity in medical devices commissioned by the Department of Health and Social Care (“Review”).  The Government Response is not guidance nor policy rather it is intended to act as an action plan for tackling potential bias in the design and use of medical devices.  The Government Response fully accepts, and in turn makes a series of commitments in response to, the findings of the Review (which is broken down into 18 recommendations, 51 sub-recommendations, and 3 further calls to action).  Importantly, the Government “wholeheartedly agrees…that medical technology should be unbiased and equitable.” 

Bias in the medical device space, and within healthcare more broadly is (quite rightly) a topic of growing importance to governments, regulators and industry alike.  We set out some key points of interest from both the Review and the Government Response below.  We look forward to seeing more developments and guidance in this area going forwards given its significance to patients and the delivery of healthcare.  

Continue Reading UK Government Outlines New Action to Tackle Biases in Medical Devices

A UK judge has decided that Odysea Ltd, an artisan food company, can use the word “raw” to describe its small-batch, minimally‑processed honey.  Judge Neville, of the First‑tier Tribunal (General Regulatory Chamber), gave the decision on 26 February 2024.  The judgement is available here and opens with a classic reference to Winnie the Pooh:

  1. The things that make me different are the things that make me me”, said Piglet, who must have seen quite a bit of honey eaten over the years.  If he treated Pooh to some “raw honey”, what would be different about it?
  2. Plenty, says Odysea, who have sold thousands of jars of honey proudly labelled as “raw”: unlike ordinary honey, ours has not been heated above its natural temperature and has undergone far less processing, so is of better quality.  Describing one of Odysea’s raw honey products, the judges at the Great Taste Awards complimented the “subtle pine and fir flavours, the perfect level of sweetness, the hint of saltiness, the sheer sexiness of this honey”.
  3. Nothing, says Waltham Forest Trading Standards, who wants them to stop: all honey is raw because it has not been cooked, so it misleads consumers to suggest that yours is special.  Odysea has had to reprint its labels to say “artisan honey” instead.  The Tribunal must decide if that is right.
Continue Reading UK Judge Permits “Raw” Label for Honey

In an earlier blog, we wrote that the German regulation of pharmaceutical pricing and reimbursement is one of the most complicated legal areas in the entire world of life sciences laws. With the new draft “Medical Research Act” (Medizinforschungsgesetz or MFG) that came out in January 2024, the German government plans to add some additional nuances to this system.

Earlier this week, we had discussed the Medical Research Act in a separate blog where we discussed the proposed amendments for clinical trials in Germany. In this blog, we will focus on the proposed changes in the area of drug pricing and reimbursement.

1. The Medical Research Act and the German Market Access System

The Medical Research Act is part of Germany’s new National Pharma Strategy which aims to make Germany more attractive for pharmaceutical R&D and manufacturing. This new Pharma Strategy was announced on 13 December 2023 by the German government in a Strategy Paper. It proposes a number of measures to boost the German pharmaceutical sector (see our blog on the Pharma Strategy). On 26 January 2024, the draft Medical Research Act was distributed to stakeholders.

The Medical Research Act is a draft bill that includes legislative changes in several areas. These changes target following main areas:

  • The national laws and procedures on clinical trials with pharmaceuticals, medical devices and in-vitro diagnostics;
  • The German drug pricing & reimbursement (market access) laws;
  • The structure and competencies of regulatory agencies and ethics committees.

On the German market access system: The German drug pricing and reimbursement rules have been subject to literally numerous reforms over the past few decades. In 2011, a new system has been introduced for new drugs that is meanwhile well-known under the acronym: AMNOG (Arzneimittelmarktneuordnungsgesetz). The AMNOG system has two main steps: (1) an early benefit assessment of new drugs against a comparator treatment and (2) a subsequent negotiation of the reimbursement price based on the outcome of the early benefit assessment.

2. Proposed Changes to the Drug Pricing and Reimbursement Laws

Under the current laws, the negotiated reimbursement price for a new drug becomes public (through certain notification requirements). This can and is used by other countries as a reference when they determine drug prices. Further, the current German laws require that the AMNOG price negotiations take into account the price of the respective drug in certain other countries. Now, the Medical Research Act aims to restrict these possibilities for international reference pricing – in both directions.

The key proposals for the drug pricing and market access area include following measures:

a) Confidentiality of Reimbursement Prices for new Drugs

The new law introduces the option for pharmaceutical companies to agree on confidentiality of the reimbursement amounts for their new drug. This can be subject of the AMNOG negotiations with the federal health insurance association (GKV-Spitzenverband). The confidentiality would apply until the expiry of the product’s regulatory data exclusivity. Consequently, the agreed reimbursement price would not be listed in public sources and not even be told to pharmacies. The product would be sold with the (higher) price that the company determines and not with the agreed reimbursement price.

Hence, the new law would allow pharma companies to have two prices: the “public” price on the product package and the “real price” that was agreed in the AMNOG process. In return, the companies will be required to reimburse the health insurance funds and other payors the overpaid difference between the “public” and the “real price”. To enable healthcare insurances a control mechanism for this compensation claim, the pharma companies need to notify the “real price” to a limited group of stakeholders.

The option to keep the reimbursement amount confidential has long been a request of pharmaceutical companies as the German prices are often used as a reference price in other countries. Several companies who came out of the AMNOG process with a low reimbursement price withdrew their products from the German market in order to avoid a subsequent price erosion in other countries. Insofar, the Medical Research Act aims to avoid such scenarios.

However, based on the proposed laws and procedures in the Medical Research Act, we doubt whether the “real” reimbursement amount can really be kept confidential. As such, the law introduces an information claim against the health insurance association for customers that purchased such drugs so that these customers could get access to the “real” (confidential) price.

Overall, the new rules would also lead to more bureaucracy, complexity and costs in a system that is already extremely bureaucratic and complicated.

b) Drug Prices in other European countries shall no longer influence the German reimbursement prices

Related with the option for confidentiality of the German reimbursement price, the Medical Research Act also proposes that in the future the price of such products in other European countries shall no longer be considered in the German price negotiations. Under the existing laws, the sales prices in other European countries are taken into account in the reimbursement price negotiations (subject to some additional requirements). Under the new laws, this existing requirement for an “inbound” international reference pricing will be removed from the German AMNOG drug pricing laws.

c) Restricting the substitution of “confidential price drugs” by cheaper import drugs

The Medical Research Act also proposes that pharmacies shall no longer substitute medicines that have a confidential reimbursement price with cheaper (parallel) import drugs. To save costs, the existing German laws stipulate that in certain cases pharmacies must dispense identical but cheaper imported drugs instead of the more expensive locally launched drug. Since confidential reimbursement amounts remain unknown to pharmacies, they cannot determine the price difference against import drugs. Hence, the substitution obligation will be lifted for drugs with confidential reimbursement amounts.

3. International Consequences of the Reform

Over the last decade many pharmaceutical companies with innovative drugs chose Germany as their first launch country in the EU. One reason is that the timelines of the AMNOG process are strictly regulated and offer predictability. Germany is also still a high-price country for new drugs and offers an initial free pricing period of 6 months (until recently, 12 months).

For companies operating in Germany, the above outlined changes to the pricing and reimbursement laws can have a positive impact. The Medical Research Act notes that the confidentiality option has been requested by the pharmaceutical industry for a while. In fact, this could be an interesting new instrument, especially for companies whose products come out of the AMNOG process with an unsatisfactorily low price. 

Overall, it is an important point in the Medical Research Act that the law aims to restrict the (inbound and outbound) international reference pricing. Therefore, these changes would not only affect Germany but also the drug pricing situation in other countries.

Having said this, we again underscore that the way the Medical Research Act envisages to implement the proposed confidentiality of the reimbursement price is very complicated and has a number of loopholes.  

4. Next Steps of the Reform

The Medical Research Act is currently out for public consultation. On 20 February 2024, already next week, there will be a hearing about this draft with stakeholders. All interest groups can submit comments until 22 February 2024. It is a bit unusual that the hearing takes place before the stakeholder comments are collected. This is an indication that the German government is determined to implement the new law quickly to execute on the new Pharma Strategy. The above described changes are scheduled to take effect on 1 January 2025.

It remains to be seen whether all proposed amendments that we have discussed in this blog will be implemented as set forth in the current version of the draft bill. Usually, there will be changes in the course of the legislative deliberations – and we expect that there will be changes to these proposed rules, too. Therefore, affected companies and stakeholders should closely monitor the legislative process and consider submitting comments.

The Life Sciences Team of Covington & Burling LLP in Frankfurt (Germany) will keep you posted about the next developments.

***

Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented the draft for a “Medical Research Act” (Medizinforschungsgesetz or MFG). The draft bill proposes legislative amendments in several areas that span from clinical trials, GMP issues for ATMPs up to pharmaceutical pricing and reimbursement (AMNOG) as well as administrative re-organizations of regulatory agencies and Ethics Committees.

This blog discusses the proposed changes for clinical trials with pharmaceuticals, medical devices and companion diagnostics.

1. Background

The Medical Research Act is part of Germany’s new National Pharma Strategy which aims to make Germany more attractive for pharmaceutical R&D and manufacturing.

On 13 December 2023 the German Federal Government officially published a Strategy Paper (Strategiepapier) for the new Pharma Strategy. We had reported in a previous blog on this development when the Strategy Paper was not yet approved within the Government.

The discussions about a Medical Research Act were ongoing since the summer of 2023. Now, the German Government appears determined to push this forward. On 26 January 2024, the draft bill was distributed to stakeholders. The public consultation is currently ongoing and comments can be submitted by 22 February 2024. On 20 February 2024, the public hearing is scheduled.

In the following, we will summarize the proposed changes for clinical trials with pharmaceuticals, medical devices and companion diagnostics and discuss some of their background and implications.

2. Proposed changes for Clinical Trials in the Medical Research Act

With respect to clinical trials, the Medical Research Act proposes following core changes:

  • Ethics Committee procedures will be reorganized and Ethics Committees will be specialized for specific indications. This will be one of the most significant and most controversial amendments. A “Federal Ethics Committee” will be established that will (initially) be in charge of clinical trials that are particularly urgent or demanding. Its competence shall encompass clinical trials with an overarching master protocol with several sub-studies, clinical trials in which new medicinal products are tested first-in-human and clinical trials with Advanced Therapy Medicinal Products (ATMPs). Further, the Ethics Committees are expected to follow binding guidelines on the application and interpretation of the Clinical Trials Regulation (EU) No. 536/2014. The German Association of Medical Ethics Committees, a non-profit association, will be charged to issue such guidelines for Ethics Committees.
  • Companion Diagnostics (CDx): The procedures and competencies for clinical trials using CDx will be streamlined and simplified. Currently, the national rules for clinical trial applications for studies that investigate a medicine together with an unapproved CDx are very complicated and burdensome. Inter alia, for combined pharmaceutical/CDx-studies two separate regulatory approval applications must be submitted. A centralized or single-gate approval procedure would be a significant simplification for the industry.
  • Decentralized Clinical Trials (DCTs): The proposed new act will facilitate DCTs by modifying the pharmaceutical distribution rules. The new rules would enable clinical trial sponsors to have the study drugs directly distributed to trial participants. This will require a change of the rules for the so-called special distribution channel under German pharmaceutical laws. However, the sponsor companies need to be careful from a data protection perspective as the direct shipment of investigational products to study subjects can endanger the pseudonymization and study blinding. Hence, sponsors need to consider data protection safeguards to not to jeopardize their DCTs.
  • Electronic Informed Consent becomes a more practical alternative to written consent. This will also be helpful for decentralized clinical trials.
  • The rules for labeling of investigational products will be amended to allow a labeling of these products in English only.
  • Standard Contractual Clauses for clinical trial agreements shall be published by the German Government to accelerate the contracting process and expedite the start of clinical trials. So far, a legal obligation to use those standard contractual clauses is not envisaged in the draft bill but their purpose is to enable standardization. However, industry stakeholders are concerned that the clauses may not be flexible enough to consider the specific circumstances and requirements of the respective clinical trials.
  • The process for Radiation Protection Approvals for clinical trials that use ionizing radiation will be significantly revised. This is another area where the Medical Research Act includes a really fundamental reform. Currently, this approval process under the German radiation protection laws with the separate agency BfS is reported to slow down clinical trials. In the future, this process and its timelines shall be linked with the general clinical trial approval procedure. The deadlines for Radiation Protection Approval and related procedures will be shortened in favor of trial sponsors. Additionally, a Single-Gate Approach for all procedures is envisages. This means that the same electronic submission portal will be used for the procedure under radiation protection law as for the procedure under medicinal product or medical device law.
  • Reorganizing BfArM and PEI: Germany is the only EU member state that has two different regulatory agencies (BfArM and PEI) in charge of approving clinical trials and marketing authorizations. While BfArM is responsible for “classical” synthetic medicinal products, PEI oversees inter alia vaccines, blood products and ATMPs. BfArM and PEI have similarly split competencies for the approval of clinical trials with medical devices and CDx. It is fair to say that the allocation of tasks and roles between the German federal agencies is quite complex – and we have not yet mentioned the competencies and roles of the authorities in the 16 German states… The Medical Research Act aims to reorganize the competencies between BfArM and PEI and to ensure a more intensive coordination and procedural improvements. Based on comments from stakeholders, there are also concerns that the practical implementation of such a reorganization of the agencies may cause difficulties and brain-drain. It will indeed be interesting to see how this will work from a logistical perspective since BfArM and PEI are approx. 175 kilometres away from each other.
  • ATMP and GMP: The new act aims to harmonize the situation in Germany around the interpretation of GMP guidelines for Advanced Therapy Medicinal Products (ATMPs). Due to Germany’s federal structure with 16 states and the independence of the state authorities, there are regularly inconsistencies in the interpretation especially of the ATMP laws and GMP/GCP guidelines. Under the new Medical Research Act, there will be official interpretation recommendations by the competent federal authority on these ATMP GMP guidelines. The state authorities will be entitled to ask the federal authority for clarification of the interpretation GMP guidelines for ATMPs.

3. Next Steps of the Reform

The draft Medical Research Act shows that the German Ministry of Health is already well advanced in its deliberations on how to implement the German Government’s new National Pharma Strategy. Although this is still a ministerial draft, it is clear that the reform will not just lead to minor legal amendments but rather significant changes for the national clinical trial laws.

These changes to the clinical trial laws will impact pharmaceuticals, medical devices and in-vitro diagnostics, among these especially companion diagnostics.

Many of the proposed changes will indeed be helpful for companies and researchers as they will in fact reduce regulatory burden and bureaucracy. In so doing, the Medical Research Act could make Germany more attractive for clinical trials in the longer term.

However, at the same time, many of the proposed legislative changes are also quite controversial and there will be pushback by different stakeholders. As with other draft laws, there will likely be changes to this one as well. Like a famous German politician once said, “no law leaves the Parliament in the same shape as it entered the Parliament”.

It is not yet clear when the Medical Research Act will be submitted to the Parliament for the next steps of the formal legislative procedure. However, given the advanced stage of drafting and the upcoming hearings on this draft, we expect that an official draft bill will be submitted to the German Parliament (Bundestag) shortly in the next months. In any case, the legislative process would have to be completed this year in order to meet the timeline set out in the present draft where some provisions shall enter into force on 1 January 2025.

As to next steps, on 20 February 2024, already next week, there will already be an oral hearing about this draft bill with stakeholders. All relevant stakeholders and interest groups now have time to submit comments until 22 February 2024. It is a bit unusual that the hearing will take place before the stakeholder comments are collected. It is, however, an indication that industry should be prepared for a rather fast legislative procedure.

This blog has focused on the proposed changes in the Medical Research Act that will affect clinical trials. However, the draft bill will also enact new laws that will impact other legal areas like drug pricing or manufacturing incentives. Given these broad implications of the proposed Medical Research Act, pharmaceutical, medical devices and diagnostics companies as well as other life sciences industry stakeholders should closely monitor the next steps of this legal reform.

The Life Sciences Team of Covington & Burling LLP in Frankfurt (Germany) will keep you posted about the next developments.

***

On 26 January 2024, the European Medicines Agency (EMA) announced that it has received a €10 million grant from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA). Although still in its early stages as an agency, AMA shows significant promise to harmonize the regulatory landscape across the continent in order to improve access to quality, safe and efficacious medical products in Africa. Other key organizations who are working to establish and implement the vision set out for AMA include the African Union (AU), comprising of 55 member states in Africa, the African Union Development Agency (AUDA-NEPAD) and the World Health Organization (WHO). Of importance, AMA is expected to play an important role in facilitating intra-regional trade for pharmaceuticals in the context of the Africa Continental Free Trade Area (AfCFTA).

Background to AMA and medicines regulation in Africa

Africa currently has limited harmonization of medicines regulation between jurisdictions. The functionality and regulatory capacity of national medicines regulatory authorities varies significantly. For example, many national regulators lack the technical expertise to independently assess innovative marketing authorization applications and instead adopt “reliance” procedures, whereby authorization by a foreign stringent regulatory authority or registration as a WHO pre-qualified product may be a condition for approval. Pharmaceutical manufacturers seeking to conduct multinational clinical trials or launch their products across Africa can often face challenges when navigating the divergent requirements for each country (and can face additional delays during each approval process).

Multiple initiatives in the last decade have aimed to increase the harmonization of medicines regulation across Africa with varying degrees of success, such as:

In February 2019, the AU adopted the treaty for the establishment of AMA (AMA Treaty). AMA will function as a Specialized Agency of the AU. In its press release, the AU confirmed that AMA “will serve as the continental regulatory body that will provide regulatory leadership, to ensure that there are harmonized and strengthened regulatory systems, which govern the regulation of medicines and medical products on the African continent.” AMA will have six main functions:

  1. evaluating selected medicines for treatment of priority diseases, as decided by the AU;
  2. coordinating the inspection of manufacturing sites and providing regular information regarding products for marketing;
  3. coordinating the information released regarding the medicinal products;
  4. collecting and storing information regarding the quality and safety of the selected products, sharing this information globally and collaborating with global and regional centers for safety monitoring;
  5. coordinating joint reviews of applications for clinical trials; and
  6. coordinating quality control laboratory services on behalf of national and regional regulatory authorities.

Current Status of AMA

The AMA Treaty entered into force on 5 November 2021 (after the Republic of Cameroon became the 15th country to ratify the treaty) and Rwanda was selected to host the AMA headquarters in 2022. To date, 27 countries have ratified the AMA Treaty, with more countries expected to do the same in 2024. AMA is also in the process of appointing its leadership team, which will include a director general to lead its efforts both in terms of operationalizing AMA and setting out its strategic plans for the future.

However, at this time, AMA is still in its nascent stage. AMA is yet to issue any regulatory guidelines or procedures.

Future Collaboration between the EMA and AMA

As part of the €10 million funding, the EMA aims to collaborate with African, European and international parties to progress AMA into a functioning agency. This support will include scientific and regulatory training to enable AMA to effectively evaluate and supervise medicines across the region. The EMA’s support forms part of the European Commission’s wider “Team Europe” initiative on manufacturing and access to vaccines, medicines and health technologies in Africa, which to date has deployed €1.3 billion in support.

We can only assume that the EMA will be able to share valuable learnings on the complex topic of implementing a multinational medicines regulatory authority. While much of the detail regarding how AMA will function in practice is yet to be clarified, its potential to transform the provision of medicines for a population of over 1.4 billion people is groundbreaking on a global scale.

If you have any queries concerning life sciences regulatory matters in Africa or any of the material discussed above, please contact the members of Covington’s Life Sciences in Africa practice group.

In a move that is sure to be welcomed by the diagnostics industry, on 23 January 2024, the European Commission announced proposals (Commission proposal and press release) to extend the transitional periods for certain in-vitro-diagnostic medical devices (“IVDs”) under Regulation (EU) 2017/746 (“IVDR”).  This follows similar action taken by the Commission in early 2023 to extend the transitional provisions under Regulation (EU) 2017/745 (the “MDR”) (see our prior blog post here).  The rationale applied for the latest proposal is the same as before – it aims to “ensure availability of safe devices, essential for healthcare systems, and protect patient care”.  Specifically, the latest IVD proposals are intended to address ongoing concerns regarding the availability and readiness of notified bodies to perform IVDR conformity assessments and the high number of IVDs that have yet to transition to the IVDR.  The new proposals (once adopted) will provide manufacturers with more time to comply with the new requirements of the IVDR.  Relatedly, manufacturers will be required to give notice if they foresee interruption of supply of their devices.

In addition, to improve the transparency and coordination, the Commission has proposed to accelerate the roll out of the European database on medical devices (“EUDAMED”) so that certain modules are mandatory as from late 2025.   

Continue Reading European Commission Proposes to Extend Transitional Periods for In-Vitro-Diagnostic Medical Devices