In 2023, we saw less deal activity in the German healthcare M&A market. The healthcare service provider sector was severely impacted by increasing costs (energy, rent, and staff), inflation, staff shortages, and regulatory and macroeconomic uncertainties. The pharma, biotech, healthcare-IT, and consumer health M&A markets remained strong, even though the overall deal volume decreased. However, deal activity picked up in the last quarter of 2023.
Focus on Healthcare IT
In the healthcare service sector, inflation, rising costs, and a shortage of skilled and unskilled staff have led to a heightened focus on improving the efficiency and quality of care delivery. This is being achieved through innovative healthcare IT solutions and exploring how generative AI can be utilised in these settings. 2024 is expected to see an increase in scope deals and investors seeking access to disruptive technologies, innovative products, and leading market positions.
Consolidation and Secondaries
The inpatient sector has been significantly impacted by recent cost increases (energy, rent, and labour costs), inflation and the inability to pass on these quickly increasing costs to customers, the expiration of public funding provided during the COVID-19 pandemic, the fiscal situation of public payors, and staff shortages. The hospital reform will also have a significant impact on hospitals. This will likely lead to an increase in co-operations and joint ventures, divestitures of inpatient facilities, and most likely, distressed M&A.
In 2023, the global, macroeconomic, and political uncertainties led to a challenging fund-raising environment, and an increase in PE sponsor holding periods. In 2024, we will see a mix of exits, along with PE sponsors opting for secondaries and continuation vehicles to provide liquidity to limited partners and funds.
Increase of Competition from Impact, Infrastructure, and Tech-Focused Investors
Private equity and venture capital investors with specialised healthcare teams and expertise have already faced increasing competition from strategic investors in recent years due to decreased access to easy bank debt and rising interest rates. In addition, the focus on healthcare IT and generative AI solutions has already drawn the attention of tech-focused investors. It remains to be seen what influence the increased competition among investors will have on deal valuations and closing the valuation gap between sellers’ expectations and investors’ offers.
German founders usually incorporate new start-up companies in Germany. They usually choose a corporation. A corporation can either be established by a deed of incorporation or acquired from a provider of shelf companies. The minimum share capital of a German limited liability company (Gesellschaft mit beschränkter Haftung, GmbH) is EUR25,000 and half of that amount needs to be paid in at incorporation. The minimum share capital of a German stock corporation (Aktiengesellschaft, AG) is EUR50,000 and for an entrepreneur company (Unternehmergesellschaft, UG) EUR1. The registration of a newly established corporation in the commercial register usually takes from two to ten business days.
When choosing the correct type of entity, founders should, among other things, consider the desired corporate governance structure and required flexibility, limitation of liability, transfer restrictions, as well as tax implications. So far, the most common type of entity at incorporation of a start-up is a GmbH or its “little” sister the UG, because they provide the most flexibility. Some start-ups already choose the form of an AG because, while the corporate rules are stricter and more formal, stock can be more easily transferred (a GmbH share can only be transferred by notarised deed) and the members of the management board and the supervisory board are not considered employees for wage tax and social security purposes.
Early-stage financing is usually provided by business angels, family offices, local and (to a lesser extent) foreign investors as well as government-sponsored funds, public subsidy programmes and subsidised loans.
Venture capital is mainly provided by European (and sometimes US and other foreign) VC funds as well as government-sponsored funds (eg, High-Tech Gründerfonds). While venture capital is generally available for start-ups in Germany, valuations are often lower in comparison to, for example, the US venture market.
In Germany, we do not yet have one standard set of documents that will be used for venture capital transactions. Most legal advisers active in the VC market have developed standards that are also based on standard documentation from other jurisdictions. However, some VC organisations have also developed standard documents that can be used for VC transactions, notably the German Standards Setting Institute (GESSI).
In general, start-ups often retain the legal form and jurisdiction in which they were established. In order to be listed on a stock exchange, a GmbH needs to change its legal form to an AG or SE. Under the German Transformation Act (Umwandlungsgesetz, UmwG), a change of legal form requires a notarised shareholder resolution with a qualified majority of at least three-quarters of the votes. The change of legal form becomes effective upon registration in the commercial register.
In Germany, investors in a successful start-up most often choose a private sale as a means of exit. Exits by IPO are still in the minority. Given the global uncertainties, such as the war in Ukraine and the conflict in Gaza, as well as numerous political elections this year, it is unclear whether IPOs of healthcare start-ups will increase in 2024. It remains to be seen whether the changes in the German stock corporation law that became effective in 2024 (in particular the inclusion of rules on SPACs) will trigger an increase in IPOs. Additionally, due to the costs and complexity involved, dual-track processes have been rare in the healthcare sector in recent years.
The choice of listing depends on a number of factors such as the target market, the attractiveness of an index, etc.
The choice of listing does not impact the applicability of German corporate law to corporations incorporated in Germany. In addition, the rules of the exchange will apply.
The sale process may be initiated by an interested party or by the company. Often, when the company initiates the sale process, it will engage an M&A adviser and contact a number of potential buyers with the aim of entering into a competitive auction process with two or more interested parties. Auction processes are quite common in healthcare transactions in the German market.
In healthcare transactions, the transaction structure is often not just driven by tax and liability considerations but also by regulatory considerations and questions regarding the transfer of assets, data, and IP. The easiest way to transfer all assets, rights, and contractual relationships is through a share or interest deal. A buyer will usually seek to acquire all, or at least the majority of, shares in the VC company. If the founders are still active in the company and vital for achieving the planned growth or other milestones, they will often be asked to keep a certain stake in the company or reinvest by contributing some of their shares to the buyer entity (roll-up or roll-down). Under certain conditions, this allows for a tax-neutral exchange of shares.
If a share deal is not possible (eg, due to factual, tax, or inherent risk reasons), the transaction might also be structured as an asset deal. In that case, all assets, rights, and contracts need to be transferred individually according to the applicable rules for transfers of such assets or rights. Contracts can only be transferred if the other contractual party agrees to such transfer.
Mergers are not very common in the healthcare sector in Germany.
Most transactions are structured as a sale for cash. Sometimes founders are provided with the opportunity to sell a certain amount of shares for cash and contribute the other shares against issuance of shares in the buyer. In German healthcare transactions, the cash compensation is often split into an upfront payment and certain earn-out or milestone payments later on.
The purchase agreement will usually provide for:
VC and PE investors are often reluctant to provide business warranties, in which case they are provided solely by the founders and/or management. In particular, in auction processes, the shareholders of the VC company incentivise bidders to offer a W&I insurance limiting the liability of the selling shareholders for warranty breaches to EUR1. In bigger mid-cap, as well as high-cap, transactions, the use of W&I insurance has increased. In some auction processes, the sellers even offer stapled W&I insurance packages.
Spin-offs are one of three ways under the German Transformation Act to divide one company into several enterprises by way of partial universal succession. The other two are split-ups and hive-downs. In a spin-off, a part, or several parts, of the assets of a legal entity are transferred to a newly formed entity in return for shares in this newly formed entity being issued to the shareholders in the transferring legal entity. The main feature being that all assets, rights, and contractual relationships transfer to the new entity by way of partial universal succession. Spin-offs can be a great tool to separate certain products, branches, or risks. In the healthcare sector, spin-offs are sometimes used to transfer early-stage products or high-risk or high-growth parts into a new entity to win investors (who would not be interested in investing in the main business of a healthcare company), to ring-fence liability/certain risks associated with early-stage products and services, to find joint venture or co-operation partners for that part of the business, or to prepare for a sale or an IPO.
Spin-offs may trigger taxes on the shareholder or corporate level, in particular if hidden reserves are realised. However, spin-offs that meet certain requirements can be structured tax free. The main conditions for a tax-free structure are:
During a spin-off, offsetable losses, remaining loss carry forwards, uncompensated negative income, interest carry forwards and EBITDA carry forwards of the transferring corporation are reduced in proportion to the assets transferred to another corporation based on their market values.
In recent years, the relevance of carve-out transactions has increased in Germany. Whether a spin-off followed by a business combination is the appropriate transaction structure depends on a number of operational, tax, regulatory, and other legal issues. Considering the tax consequences, for the sellers, of a spin-off in preparation for a business combination (see 5.2 Tax Consequences) and certain tax benefits of an asset deal for the purchaser (eg, higher amortisation potential), spin-offs are more often used for corporate restructuring purposes (focusing assets and efforts, separating risks, etc) rather than in preparation for a business combination.
The timing of a spin-off depends on certain factors, such as the existence of minority shareholders or a works council (then waiting periods will apply), cash pooling arrangements, and the separability of the business unit from the rest of the business. This requires detailed planning. A spin-off is usually implemented within a time period of two to eight months. If there is uncertainty about whether the preconditions for a tax-neutral spin-off are met or how realised hidden reserves will be evaluated, obtaining a binding tax authority ruling, which takes roughly three months, can be beneficial.
To a certain extent, it is possible to acquire shares or increase a stake in a public company prior to making an offer. However, anyone who (alone or in concert with others) reaches, exceeds, or falls below 3%, 5%, 10%, 15%, 20%, 25%, 30%, 50% or 75% of the voting rights in an issuer by means of acquisition, sale or in any other way must notify the issuer and the Federal Financial Supervisory Authority (Bundesanstalt für Finanzdienstleistungsaufsicht, BaFin) immediately, at the latest within four business days.
Acquirers are obligated to make a mandatory takeover offer if they (alone or in concert with others) gain control of listed stock corporations, SE, or partnerships limited by shares (Kommanditgesellschaft auf Aktien, KGaA), other than through a voluntary takeover bid, for the first time. The control threshold is a minimum of 30% of the voting rights in the target company. Under certain conditions, BaFin may grant exemptions from the attribution of voting rights or the obligation to publish an offer in individual cases.
Public companies are usually acquired by way of making an acquisition offer or a voluntary or mandatory takeover offer. Public mergers are quite rare in the German healthcare market.
The offered consideration must consist either of a cash payment in euros or liquid shares that are admitted to trading on an organised EEA market. Shares offered as consideration for voting shares must also grant voting rights.
In the case of an acquisition offer, no minimum price rules apply. In the case of a takeover offer, the consideration needs to be adequate. Shareholders of the same class have to be treated equally. If the shares of the target company are admitted to trading on a stock exchange, the consideration must be at least equal to the weighted average domestic stock exchange price of these shares during the last three months prior to the publication of the offer.
Prices paid in the stakebuilding process also influence the minimum price. The consideration for the shares in the target company must be at least equal to the value of the highest consideration granted or agreed by the bidder, a person acting jointly with the bidder or their subsidiaries for the acquisition of shares in the target company within the last six months prior to the publication of the offer.
Common conditions for a takeover offer in the German healthcare space are merger clearing, required regulatory approvals, obtaining clearance required under the foreign investment control rules, and minimum acceptance thresholds. The conditions must be objective (not under the control of the bidder) and must be met by the end of the acceptance period. In case of a mandatory takeover offer, only merger, foreign investment control, and other regulatory conditions are allowed.
In preparation for a friendly bid, the bidder will often contact the target’s management board in advance. Then, an investment agreement or business combination agreement might be concluded. Subject to ad-hoc and other disclosure rules, the bidder and target may also agree on a non-disclosure and confidentiality agreement.
Sometimes, we see irrevocable undertakings by existing shareholders including warranties given to the bidder. The target itself does not provide warranties due to, among other things, capital maintenance and financial assistance rules as well as the fact that the management needs to act in the interest of the company.
However, in recent years, the number of hostile takeover offers has increased. Here, the deal documentation mainly consists of the takeover offer documentation as reviewed by the Federal Financial Supervisory Authority (Bundesanstalt für Finanzdienstleistungen, BaFin).
Minimum acceptance conditions are only allowed in the case of voluntary takeover offers. The thresholds are determined by the level of control the bidder wants to acquire – eg, acquiring a majority in the general meeting (based on historic attendance numbers), acquiring a qualified majority of 75% of the target, or meeting the requirements of a squeeze-out, etc.
One way to achieve a squeeze-out is the merger of the target entity with the majority shareholder holding at least 90% of the voting rights in the subsidiary. Such a squeeze-out by merger is possible if the involved entities are stock corporations, SE or KGaA. Irrespective of the legal form of the shareholder, the German Stock Corporation Act (Aktiengesetz, AktG) allows a majority shareholder holding 95% of the share capital to initiate a shareholder resolution on the squeeze-out against cash compensation.
The offer document published by the bidder needs to contain information on how the offered compensation is financed. The offer cannot be conditional upon the attainment of financing. That means that, in the case of debt financing, the CPs under the loan agreements should match the conditions under the offer and should not fall outside of the control of the bidder (eg, MAC, etc). In addition, if all or part of the compensation offered is in cash, a financial institution – usually a bank – independent of the bidder must confirm that the bidder has taken the steps necessary to ensure that it will be able to pay the cash compensation when due.
Bidders mostly seek deal protection by entering into irrevocable undertakings and conditional stock purchase agreements with strategically important shareholders. In cases of a friendly takeover, acquirers will try to enter into a business combination agreement with the target.
As a general rule, the management of the target company may only agree to deal protection measures such as, for example, break fees or no-shop obligations if this is in the best interest of the target and not in breach of the rule of neutrality. In cross-border cases, targets sometimes agree to a break fee in case of third-party interventions. Such break fees must be drafted carefully to prevent a violation of financial assistance prohibitions.
If, after the offer, minority shareholders remain in the company, the bidder might nevertheless seek to gain additional governance rights. With a vote of at least 75% of votes represented in a general meeting, the general meeting might resolve on the conclusion of a domination (and profit and loss pooling) agreement. If the bidder acquired 90% or more of the shares, it might be able to squeeze out the minority shareholders (see 6.8 Squeeze-Out Mechanisms).
Irrevocable commitments or undertakings from principal shareholders are common in Germany, in particular with respect to institutional investors. When entering into these agreements, a bidder needs to comply with the obligation to treat shareholders of one class of shares equally. Furthermore, existing irrevocable commitments must be disclosed in the offer.
Before announcing its decision to launch an offer for the target shares, the bidder needs to notify BaFin and the relevant stock exchanges thereof. The offer itself must be submitted to BaFin who will review the offer document for completeness and obvious violations of the German Securities Takeover Act (Wertpapiererwerbs- und Übernahmegesetz, WpÜG) within ten (+ five in case of comments) business days.
Within four weeks (extendable to a maximum of eight weeks in exceptional cases) after announcing the decision to launch an offer or after gaining control for the first time, the bidder needs to submit the offer to BaFin. BaFin will review the offer for completeness and obvious violations of the WpÜG within ten (+ five) business days. The offer must then be published immediately.
The management and supervisory board then have to publish an opinion including reasons for the takeover offer without undue delay (at least within two weeks).
The acceptance period for a voluntary offer is determined by the bidder but may not be shorter than four weeks or longer than ten weeks. The final number of shares tendered must be published by the bidder after the end of the acceptance period without undue delay, and shareholders then have a further two weeks to accept the offer. The acceptance period may be extended if a competing offer is published with a longer acceptance period.
The consummation of the offer occurs once all regulatory approvals/conditions are fulfilled.
The operation of a new healthcare company is typically subject to various general regulatory license requirements. In addition, healthcare companies that provide services in the statutory health insurance system require a specific admission that is often subject to capacity planning. Such admissions are granted by different regulatory bodies by way of an administrative order or by way of an admission contract. For example, admission as a medical care centre (Medizinische Versorgungszentren, MVZ) in the outpatient sector is granted by the admission board which consists of representatives of the statutory health insurance funds and representatives of the panel doctors’ association. Admission as a so-called plan hospital is granted by the competent health ministry of the federal state where the hospital is located. Depending on the respective subsector, the licensing of a new company can take between three and six months.
The primary securities market regulator for M&A transactions in Germany is BaFin.
Foreign direct investments (FDI) in German companies are restricted under the Foreign Trade and Payments Ordinance (Außenwirtschaftsverordnung, AWV). Restrictions generally apply to certain investments across all sectors by investors from outside the European Union and the European Free Trade Association (EFTA). Specific regulations apply to acquisitions of certain defence and IT security companies. FDI screening generally applies to share deals in which the acquirer acquires voting rights that exceed certain thresholds (10%, 20% or 25%) and to asset deals that result in respective voting rights. The applicable threshold depends on the respective target company’s specific business.
During the COVID-19 pandemic, the German government extended foreign investment control to transactions in the healthcare sector. Since then, manufacturers of vaccines and antibiotics, manufacturers of certain medical equipment and certain medical devices for the treatment of highly contagious diseases, as well as hospital operators and laboratory service providers, qualify as safety-relevant companies. Consequently, the direct or indirect acquisition of a certain percentage of the voting rights in such companies needs to be notified to the competent Federal Ministry of Economics and Climate Protection (Bundesministerium für Wirtschaft und Klimaschut, BMWK). A FDI clearance decision is required prior to the implementation of the respective transaction.
In the case of acquisitions in Germany by non-EU acquirers, the public interest and national security are protected by foreign investment reviews (see 7.3 Restrictions on Foreign Investments). Applications must be submitted to the BMWK. If an acquisition affects areas of responsibility of other federal ministries (eg, the Federal Ministry of Health), the BMWK will involve them in the foreign investment procedure.
Investors from certain countries could be subject to sanctions law (including Russia and Belarus), preventing them from investments in Germany.
German export controls focus on preventing the proliferation of weapons of mass destruction and the uncontrolled transfer of conventional arms. At the same time, sensitive goods are to be prevented from being used for internal repression or other serious human rights violations, or from being supplied abroad or otherwise made available to promote terrorism. Activities in certain sectors are specifically listed for export control, including biology, biotechnology, and medicine. In the area of research and development, this list generally requires broad interpretation (eg, the generic term “general electronics” also covers medical technology).
A notification to the Federal Cartel Office (Bundeskartellamt) is required if the turnover of the undertakings participating in the concentration reaches the following thresholds in the previous year:
If the above thresholds are not met, notification may still be required if the following criteria are met:
If a notification is required, the transaction may only be implemented after clearance by the Federal Cartel Office. Violation of the standstill obligation can result in a fine of up to 10% of the worldwide group turnover. Notifiable mergers implemented prior to clearance are pending and ineffective and may be unwound if the conditions for clearance are not met.
During the due diligence of a German target, certain labour law regulations need to be considered. The labour law due diligence in healthcare transactions should in particular cover employee benefits, existing employee pension schemes, applicable collective bargaining agreements (either directly or by reference in the employment contracts), the use of freelancers such as honorary physicians, in particular, with respect to so-called bogus self-employments, accrued holiday and overtime, employment disputes, and layoff and retention strategies (also with respect to the extensive protection of employees against unfair dismissals).
Whether existing works councils or economic committees have to be involved depends on the transaction structure and the consequences of the transaction for the business and its employees.
M&A transactions in the healthcare sector do not require a central bank approval.
In its decision dated 9 November 2021 (VIII ZR 362/19), the Federal Civil Court (Bundesgerichtshof, BGH) held that the isolated sale of patient data violates professional law and potentially also criminal law (prohibition of kickbacks for referrals). In this case, the purchase agreement exclusively aimed at the transfer of patient data or the “goodwill” of a dental practice. Under the purchase agreement, the seller was obligated to redirect calls from patients and enquiries via its website to the purchaser and recommend the continuation of treatment under the new ownership. This arrangement, where the purchase price was strictly for these referrals, did not involve the transfer of any tangible assets. The BGH emphasised that while purchasing a medical practice in its entirety is acceptable, agreements solely focused on the referral of patients are not.
Moreover, the BGH has issued several rulings in the context of drug advertising law that restrict the business models of telemedicine providers, mail-order pharmacies, and providers of online platforms for healthcare services (eg, ruling dated 9 December 2021, I ZR 146/20 and ruling dated 9 February 2023, I ZR 114/22).
The management of a public company is generally allowed to disclose due diligence information to potential bidders, provided the disclosure is in the best interest of the company. No specific limitations with regard to public healthcare companies exist, except for the limitations that derive from general and health data protection laws.
The disclosure of data from seller to buyer in the course of the due diligence must comply with general data protection rules. In particular, the GDPR generally requires a legal basis for the transfer of personal data. Personal data and health data are particularly protected. Against this background, employee data and health data must be anonymised before such data is disclosed in the due diligence of a healthcare company.
If a bidder decides to make an offer, it needs to notify BaFin and the relevant stock exchanges thereof.
Within four weeks (extendable to a maximum of eight weeks in exceptional cases) after announcing the decision to launch an offer or after gaining control for the first time, the bidder needs to submit the offer to BaFin. The offer needs to include, inter alia, the following information:
In general, the bidder is not obligated to publish its full financial statements in the offer. For the financial information regarding the bidder that needs to be included in the offer, see 10.2 Prospectus Requirements.
The offer has to be in German, and it has to be published, inter alia, on the internet.
The management of the target has to act in the best interest of the target company and may not accept benefits or preferential treatment from the bidder. The management board together with the supervisory board also has to publish a reasoned opinion on the offer without undue delay after the publication of the offer. This reasoned opinion needs, among other things, to comment on the consideration offered, the likely consequences of a successful offer, the goals being pursued by the bidder and any intention of board members holding target securities to accept the offer.
In Germany, no requirements for special or ad-hoc committees exist.
The board will be more deeply involved in the process in cases of a friendly takeover or in cases of a hostile takeover that is not recommended by the boards.
In most cases, the management board and the supervisory board will obtain independent legal and financial advice. For the purpose of the reasoned opinion on the offer they also usually obtain a fairness opinion.
Deal Activity
German healthcare companies are affected by general global trends such as high inflation rates and increased costs for debt financing, personnel, energy, and supplies. Despite these challenges, the German healthcare M&A market remained resilient in 2023; however, there was a drop in the number of high-volume transactions, and new investors were somewhat cautious about entering the market, largely due to regulatory uncertainties.
Hospitals are facing structural changes and have been suffering from a funding crisis for years. Against this background, many transactions in the inpatient hospital and care market in the past two years were either related to insolvencies or hospital mergers.
The number of transactions in the outpatient sector increased in 2023. Most transactions were add-on acquisitions of medical care centres (Medizinische Versorgungszentren, MVZ) by established strategic and financial investors and led to further consolidation; eg, in the fields of radiology, dermatology, orthopaedics, clinical pathology, and laboratory diagnostics.
The market share of venture and risk capital investments in the German healthcare market has increased over the past years, primarily in the areas of digital health, AI and biotech, where PE and VC investors often compete with strategic investors.
Impact of Regulation
The German healthcare market is highly regulated and governed by several regulatory instruments that have an impact on M&A transactions. Regulation is subject to frequent changes. Reform plans of the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) in the inpatient sector and the announcement to further restrict the participation of private investors in the outpatient physician market have influenced M&A activity in the past two years.
Healthcare companies must be corporations and free of third-party ownership restrictions in order to qualify as a suitable target for M&A transactions. Pharmacies are subject to a strict third-party ownership prohibition under German pharmacy law. German pharmacies are therefore not suitable targets of M&A transactions. Indirect third-party ownership restrictions also exist in the outpatient market. Private investors cannot directly acquire MVZs. Instead, they have to acquire a hospital that is designated for treating publicly insured patients through its inclusion in the state hospital plan (Plankrankenhaus, “plan hospital”) as a transaction vehicle.
Almost 90% of the German population is covered by statutory health insurance, whereas only approximately 10% of patients are privately insured. Against this background, most healthcare and life sciences companies traditionally generate a large part of their revenues from services and products that are reimbursed by the statutory health insurance. Therefore, social security regulation is an important factor to be considered in M&A transactions, particularly in the healthcare services sector. Social security law has an impact on market access where healthcare services are subject to capacity planning (eg, in the hospital sector and in the outpatient physician services sector).
Social security law significantly influences the eligibility of products and services for reimbursement by statutory health insurance. Moreover, various instruments of price regulation exist. Reimbursement prices for healthcare services under statutory health insurance are negotiated between providers and statutory financing entities. Reimbursement prices under statutory health insurance for new medicinal products and digital health applications (Digitale Gesundheitsanwendungen, DiGA) are determined by way of a cost-benefit assessment by the Federal Joint Committee (Gemeinsamer Bundesausschuss, GBA) and the Federal Institute for Drugs and Medical Devices (Bundesamt für Arzneimittel und Medizinprodukte, BfArM) respectively.
Shortage of Qualified Staff and Increasing Wage Costs
The severe shortage of qualified healthcare personnel accompanied by increasing wage costs is considered one of the biggest challenges for the German healthcare market and accordingly for investments in this market.
The lack of qualified personnel is particularly challenging for the inpatient sector, where statutory staffing requirements exist that stipulate a minimum staff-patient ratio. Hospitals that fail to meet these staffing requirements risk fee cuts.
Providers of inpatient and outpatient care also struggle with staffing requirements stipulated in the care contracts with the social security funds. In addition, since 2022, care providers are obligated to remunerate their staff either in accordance with a collective agreement or at the usual regional pay level. However, reimbursement rates from statutory funds often do not keep pace with the rising personnel costs.
Furthermore, efforts to mitigate staff shortages through the recruitment of foreign nursing personnel frequently run into bureaucratic and regulatory barriers. Moreover, providers that do not meet the statutory staffing requirements risk fee cuts and non-compliance, or even criminal investigations. Under German case law, the billing of healthcare services that are non-compliant with regulatory requirements may constitute fraud.
Against this background, an in-depth compliance review of a healthcare company is an important part of due diligence.
Digital Health
The term “digital health” as a collective term includes digital healthcare services such as telemedicine, medical software applications such as DiGAs, medical devices with integrated AI, or healthcare IT that is used for data management – for example for coding hospital services as part of medical controlling, for billing healthcare services or for arranging doctor's appointments.
The range of providers and transaction objects in the field of digital health is correspondingly diverse. In 2022 and 2023, there was an increase in venture capital investments in health IT and DiGAs.
DiGAs or “apps on prescription” are digital medical devices of low-risk classes that support insured persons in the treatment of illnesses. They differ from fitness or lifestyle apps in terms of their medical benefits. Typical fields of application include cardiology (actensio, ProHerz, and Vantis) or psychotherapy (Selfapy and HelloBetter). Since 2020, doctors can prescribe DiGAs listed in the BfArM’s DiGA directory, with costs covered by statutory health insurance. In the first year after authorisation by the BfArM, health insurers are required to reimburse at the manufacturer’s price, although this is subject to a cap. From the second year onwards, the reimbursement price is set on the basis of a cost-benefit assessment in negotiations between the manufacturer and the health insurer.
Since 2022, insured persons who are cared for at home have also been entitled to the prescription of DiGAs listed in the BfArM’s DiGA directory.
The COVID-19 pandemic has accelerated the digitalisation of the German healthcare sector. Nevertheless, Germany still lags behind other European countries when it comes to implementing digital health technologies and solutions, in particular in the statutory healthcare system.
One reason for this may be the scepticism among traditional providers and stakeholders towards the evolving competitive landscape ushered in by digitalisation. Interest groups such as chambers of pharmacists and medical associations have a strong political lobby and exert a corresponding influence on innovative legislative proposals. Digitalisation is leading to greater networking between various players in the healthcare industry. At the same time, German law provides for numerous regulations that prohibit co-operation between different players and the allocation of patients. Providers have to deal with these regulations when developing their business models and are often confronted with disputes.
In 2023, the BMG passed a digital strategy to further accelerate digitalisation. In March 2024, the Digital Act (Digitalgesetz, DigiG) and the Health Data Use Act (Gesundheitsdatennutzungsgesetz, GDNG) entered into force. The new laws encompass, inter alia, the mandatory use of electronic patient records from 2025, the mandatory electronic prescription of pharmaceuticals from 2024, and changes in the regulatory requirements for digital health applications. The new laws also lift previous volume restrictions for telemedicine services and introduce assisted telemedicine in pharmacies.
Proposed Hospital Reform
Following a proposal by the Government Commission for Modern and Demand-oriented Hospital Care, which was established in 2022, the BMG plans a comprehensive reform of the hospital sector, which is expected to fundamentally change the German hospital market and lead to further consolidation and related M&A activity.
Key elements of the proposed reform are:
A first draft of the proposed Hospital Reform Act was published in March 2024. The reform is highly contested, among other things, because it conflicts with the original competence of the Federal States for hospital planning. It is unclear when and to what extent the proposed draft will enter into law.
It is expected that the implementation of the proposed hospital reform will lead to the closure of many hospitals, especially in rural areas, and a concentration of specialised hospitals. Such developments will trigger related M&A activity.
Outpatient Sector
Investors can only participate in outpatient medical care via MVZs. This is because, unlike conventional medical practices, MVZs can also be operated in the legal form of a GmbH. However, the law stipulates that the direct shareholders of an MVZ GmbH can essentially only be authorised plan hospitals in addition to authorised doctors. Investors must therefore acquire a plan hospital as a “transaction vehicle”, which then acts as a shareholder of the MVZ GmbH and “MVZ founder”. Until now, it has been possible to establish an unlimited number of MVZs with one hospital. The respective hospital does not need to have a specialist or geographical connection to the MVZ. For example, this means that under current law one geriatric hospital in Munich may establish an unlimited number of laboratory MVZ all over Germany.
As part of an MVZ transaction, a medical practice, often in the legal form of a civil law partnership, is usually transferred to an MVZ GmbH and the sellers become employed doctors in the new MVZ. Typical transaction structures are either an asset deal or the acquisition of the sellers’ participations in the civil law partnership by an MVZ GmbH.
At the end of 2022, the Minister of Health announced his intention to limit the ability of “investors” to establish MVZs. This followed concerns raised by medical associations about the involvement of private equity firms in healthcare. The main criticism is that the expected returns, the time horizon, and the financing of such investments incentivise the unnecessary expansion of services and worsen the quality of care. Several expert reports, including one commissioned by the BMG, have since confirmed that there is no evidence of poorer quality of care or unjustified service expansions in PE-operated MVZs.
Nevertheless, the discussion on restricting “investor MVZs” continues. Among other things, it is being discussed that in future only hospitals with a geographical or specialised connection to the respective MVZ can establish MVZs. The business model of investors, who have been able to set up MVZ chains nationwide with a single plan hospital irrespective of its specialisation, would therefore no longer be feasible.
It is still completely unclear whether and when the opportunities for investors to participate in MVZs will be further restricted. A corresponding draft law has already been announced for 2022 but is not yet available. Implementing the BMG’s plans would also raise considerable concerns under constitutional and European law. Several legal opinions are now available in this regard as well.
The BMG’s announcements have led to a considerable increase in MVZ transactions in 2023, in particular, through the acquisition of medical practices by already established providers who are further expanding their “MVZ chains” as part of their “buy-and-build” strategy before any change in the law. Should the law actually be amended, the existing MVZ structures would be grandfathered.
The increase in MVZ transactions in 2023 was also triggered by the increased willingness of doctors to sell due to the fear that they will no longer be able to sell their practices to investors at high purchase prices in the event of a reform. The trend is expected to continue in 2024 and lead to further consolidation, particularly in the capital-intensive diagnostic specialities (laboratory medicine, pathology, radiology), but also in ophthalmology and dermatology. The number of MVZ transactions in the field of dentistry fell in 2023.
In outpatient care, several providers offering hybrid care models in which analogue care is supplemented by digital services have established themselves in recent years. With the abolition of the volume limit for video consultations as part of the DigiG, such business models could be expanded in the medical sector.
Another trend is gaining traction where companies provide registered doctors and therapists with services and infrastructure, along with non-medical staff “as a service”. This model serves as an alternative to the traditional MVZ structures, aiming to alleviate the financial burden on healthcare professionals regarding investments in facilities and operation. Such business models still face regulatory hurdles, particularly in the area of statutory health insurance.