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.

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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.

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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

The European Parliament and Council are currently negotiating the wording of a new Regulation establishing a Single Market emergency instrument (“SMEI”).  This new measure builds on the experience gained from the COVID-19 crisis and gives new powers to the Commission, in close cooperation with the Member States.  This blog briefly discusses the expected impact on medical devices.

  • Background

Based on the experience with the past pandemic, the Commission published a proposal for a Regulation establishing the SMEI in September 2022.[1]  The Council published its views in June 2023 and the Parliament adopted its first reading in July 2023.  Both propose many amendments and are now trying to reach a consensus. The final version of the SMEI is thus still uncertain but this blog post seeks to summarize its expected scope and objectives, and to describe its possible impact on medical devices. 

  • Key aspects of the SMEI

The main objective of the SMEI is to preserve the free movement of goods, services, and persons, and to ensure availability of essential and crisis-relevant goods and services in times of crisis.[2]  The SMEI mechanism is based on three levels of need (contingency planning, vigilance, and emergency) and provides for procurement of goods and services:

  • Contingency planning is based on collaboration between Member States and the European Commission, and on consultation of economic sectors.  The aim is to prepare actions to mitigate supply chain disruption and monitoring incidents.
  • When a significant disruption of the supply of goods and services of strategic importance is feared, a vigilance mode can be activated.  This allows for specific measures, such as: (i) Mapping and monitoring specific supply chains and production capacity.  This can include collecting information that contains business secrets; (ii) The creation of national strategic reserves of “goods of strategic importance”, in coordination with the Commission and other Member States.
  • Finally, the emergency mode can be activated In case of severe disruption of the functioning of the single market.  It triggers specific provisions and allows for specific measures: (i) A general requirement for Member States to ensure the legality, proportionality, and transparency of measures that restrict free movement; (ii) A prohibition to ban exports to other EU Member States (or to adopt measures of equivalent effect) for listed products and on discrimination of citizens based on nationality; (iii) The European Commission can order business operators to provide information on crisis-relevant goods (and components thereof), stocks, production capacity, facilities located in third countries, etc.; (iv) The Commission can order economic operators to prioritize certain orders for the production or supply of crisis-relevant goods; (v) The Commission can issue recommendations to Member States on how to re-organize certain supply chains and production lines, and on using existing stocks to ensure the availability and supply of crisis-relevant goods and services.
  • Under the vigilance and emergency modes, the Commission can also arrange for public procurement of goods and services of strategic importance.  This can be done on behalf of, or jointly with, the Member States.
  • Impact on Medical Devices

Direct impact

The direct impact of the new SMEI on medical devices will remain limited.  The Proposal provides that the SMEI shall in general not apply to medical devices, as defined in the Medical Devices Regulation and the In Vitro Medical Devices Regulation, including accessories.  That is because there is a separate crisis regime for medicines and medical devices.[3] 

Some provisions, however, will apply to medical devices.  They include:

  • The general requirement for Member States to ensure the legality, proportionality, and transparency of measures that restrict free movement.
  • The prohibition to ban exports to other EU Member States (or to adopt measures of equivalent effect) for listed products.

The provisions that will apply to medical devices are subject to various amendments by the Council and the European Parliament.  The former in general seeks to limit the restrictions on Member State actions, while the latter suggests more restrictions.  One of the proposals of the Parliament is to establish “fast lanes” aimed at facilitating free movement for goods and services.  The fast lanes would provide for accelerated procedures for declaration, registration, or authorisation of cross-border activities, “in particular for professional services in the [area] of healthcare.

Potential indirect impact – compulsory patent license

The indirect impact of the SMEI on medical devices could be more significant.  The activation of the single market emergency mode, especially when it specifically refers to medical devices, might trigger the application of the planned EU compulsory licensing regime. 

That regime was proposed in April 2023[4] and is currently also being reviewed by the European Parliament and the Council.  It would give powers to the Commission to grant compulsory licenses in case of specific types of crises.  For health products, the crisis can be a public health emergency at EU level (formally recognized by the Commission), or the activation of the single market emergency mode.  The latter can occur for other reasons than health, for instance in case of terrorism, war, serious political tensions, economic instability, or natural disasters. 

A compulsory licensing regime may be easier to implement for medical devices than for medicines.  In certain cases, components and raw materials may be more easily available.  In addition, the possibilities for exemption from the standard conformity assessment procedures under the MDR and IVDR allow for quick regulatory approvals where needed. 

Still, as mentioned, there is a separate crisis regime for medicines and medical devices.  On that basis, medical devices are only subject to some of the provisions in the proposed SMEI Regulation.  It would then also be logical not to apply the new compulsory licensing regime to medical devices (or medicines) based on a single market emergency. 

  • Conclusion

The new SMEI will allow for specific measures to address crises that affect the operation of the single market in goods and services.  This can be triggered by a new pandemic or another serious health risk, but also by significant political, economic, or environmental instability. 

The direct impact on the medical devices industry will most likely be limited.  Where the SMEI applies, in general the measures will also support the industry as they are aimed at safeguarding the single market.  The indirect impact, however, by potentially triggering the EU compulsory licensing regime for patents, might be more significant. The draft SMEI Regulation and the draft Regulation on Compulsory Licensing are currently going through the EU legislative procedure.  This allows for significant amendments by the Parliament and the Council.  The exact impact of the measures will thus only be clear once the texts are finalized.


[1]  European Commission, COM(2022) 459 final, 19 September 2022, available here: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52022PC0459.  

[2]  Article 1(1) of the Proposal.

[3]  Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices, Regulation (EU) 2022/2371 on serious cross-border threats to health, and 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.

[4]  European Commission, COM(2023) 224 final, 27 April 2023, available here: https://single-market-economy.ec.europa.eu/publications/com2023224-proposal-regulation-compulsory-licensing-crisis-management_en.

The Holiday season of 2023 proved to be a busy one for innovative pharmaceutical companies in the UK and their legal and regulatory teams.

UK pharmaceutical companies are already number-crunching through two new price control systems for 2024 (please see our blog and audiocast).  In addition to the UK pricing regime changing, there are proposals to update advertising rules and the procedure for adjudicating upon advertising complaints.   

On 13 December 2023, the Association of the British Pharmaceutical Industry (“ABPI”) published proposals to update the 2021 ABPI Code of Practice for the Pharmaceutical Industry (“ABPI Code”) and the Prescription Medicines Code of Practice Authority (“PMCPA”) Constitution and Procedure (which sets out the procedure for adjudicating upon advertising complaints).  Companies have until 29 February 2024 to contribute to the consultation.

Many of the proposed changes to the ABPI Code are clarificatory in nature, but the planned changes to the complaints process may be of particular interest to in-house legal teams.  These changes are designed to make the PMCPA complaints process less formulaic and more flexible.  This could help manage relatively straightforward cases with greater efficiency, whilst also accommodating for cases which involve serious allegations and/or complex facts.  If implemented as proposed, the changes are likely to give PMCPA cases a more judicial or legalistic feel, particularly when it comes to case management.

Continue Reading Consultation on Changes to the ABPI Code and UK Advertising Complaints Process

Recently announced changes to the Voluntary Scheme (VPAG) and Statutory Scheme change the paradigm for the pricing of branded medicines in the UK. Innovative pharmaceutical companies doing business in the UK must decide which scheme to join for 2024 – a decision that may significantly affect margins.

Tune into this episode of Covington’s Life Sciences Audiocast, to hear the latest on these changes from our experts, Grant Castle, Raj Gathani and Daniel Spivey.

On 20 November 2023, the UK Government and the Association of the British Pharmaceutical Industry (“ABPI”) ‒ the industry body representing the innovative pharmaceutical industry in the UK ‒ announced a new 5-year voluntary scheme for branded medicines pricing, access and growth (“VPAG”).

Although the parties have announced agreement upon heads of terms, it is already clear this is very significant news for the pricing and reimbursement of branded medicines in the UK.  It is likely to represent a paradigm-shift in the way the innovative pharmaceutical industry will view reimbursement.

Continue Reading VPAG – New 5-Year Pricing Agreement Agreed between UK Government and the UK Pharmaceutical Industry Body (ABPI)

The German government is discussing a new Pharma Strategy with a number of reforms to improve the conditions for the pharmaceutical industry in Germany. Recently, the “Strategy Paper 4.0 – Improving the General Conditions for the Pharmaceutical Sector in Germany” (original title: Strategiepapier 4.0: Verbesserung der Rahmenbedingungen für den Pharmabereich in Deutschland – Handlungskonzepte für den Forschungs- und Produktionsstandort) became public that reportedly has the backing of the German Chancellor and the Federal Health Minister.

This strategy paper presents a range of measures to strengthen, among other things, pharmaceutical research and production in Germany and to improve the market access and pricing environment. These measures would have a significant impact for a multitude of players in the life sciences field. As such, the German government anticipates faster approvals for clinical trials, faster access to innovative medicines, more digitalization, greater supply security, a more investment-friendly environment and reduction of bureaucracy. Currently, and this is widely acknowledged by the government and most stakeholders, there is significant room for improvement in all of these areas.

Continue Reading German Government pursues new Pharma Strategy with significant Reform Ideas