spectrumK is a service provider specialising in the healthcare sector and a contractual partner of statutory health insurance funds. The company develops and organises healthcare delivery and contractual models in various areas of healthcare and supports health insurance companies in particular in realising cost-effectiveness and healthcare delivery potential. The areas of activity include contract management for pharmaceuticals, medical aids, and other service areas of the healthcare sector.

The tender for exclusive rebate agreements for interchangeable biologics now being conducted by spectrumK is the first procedure of its kind in Germany. Contracts were awarded for a large part of the active ingredients tendered and the agreements were implemented on time. The participating health insurance companies thus benefit from cost-effectiveness potential that can be realised at an early stage, while the awarded manufacturers receive planning security for production and supply chains.

The start of the agreements comes in a phase of intensive health policy discussions about the future design of biologics rebate agreements. The Federal Ministry of Health recently spoke out in favour of stopping ongoing tenders without a contract award and reviewing agreements that have already been concluded. However, the agreements concluded by spectrumK were concluded on the basis of the legal situation in force at the time of the tender and the contract award.

According to ADVANT Beiten's legal assessment, there are currently good reasons to assume that the agreements that have already been validly concluded and started since 1 June 2026 will continue to exist. The agreements are based on a completed tender process and establish rights and obligations for the companies involved. The manufacturers have assumed supply obligations and aligned their production and logistics processes with the start of the agreement. In addition, wholesalers, pharmacies and other market participants were involved in the implementation on time and the necessary adjustments were made in the relevant systems.

Against this background, a subsequent reversal would not only raise complex legal issues but would also entail considerable practical challenges for the market players involved. Legal certainty and reliability are essential prerequisites for investments, supply commitments and a stable healthcare delivery, especially in the highly regulated healthcare market.

In addition, the agreements that have now been started can provide important insights for the political and regulatory discussion about the future design of biologics rebate agreements. The practical implementation offers the opportunity to gain experience with regard to cost-effectiveness, security of supply and market conduct and thus to create a reliable basis for future legislative decisions.

ADVANT Beiten has many years of experience in advising companies and institutions in the healthcare sector as well as in public procurement and healthcare law. The law firm regularly advises on complex tendering and contractual models at the interface of regulation, competition and healthcare.

Advisors to spectrumK:
ADVANT Beiten: Dr Silke Dulle, Christian Hipp, Max Stanko (all Berlin).

Public Relations
Frauke Reuther
Manager Kommunikation
ADVANT Beiten
+49 (69) 75 60 95 - 570
frauke.reuther@advant-beiten.com

Klinikum Westbrandenburg – with its two paediatric and adolescent clinics in Potsdam and Brandenburg an der Havel – was transferred back to its two shareholders, Klinikum Ernst von Bergmann and Universitätsklinikum Brandenburg an der Havel, following a demerger carried out under the law governing corporate conversions. The Potsdam site will now become part of the Klinikum Ernst von Bergmann whilst the Brandenburg an der Havel site will continue to operate as part of the Universitätsklinikum Brandenburg an der Havel.

The Ernst-von-Bergmann Group with more than 4,500 employees is currently undergoing a comprehensive reorganisation process. The current integration at the Klinikum Ernst von Bergmann in Potsdam will establish clear and sustainable structures for paediatrics and adolescent medicine whilst strengthening collaboration between the specialist departments.

ADVANT Beiten has provided comprehensive advisory services to the Klinikum Ernst von Bergmann regarding its restructuring, most recently in connection with the sale of its majority stake in Lausitz Klinik Forst GmbH.

Advisors to Klinikum Ernst von Bergmann: 
ADVANT Beiten: Dr Karl-Dieter Müller (Berlin, in charge), Benjamin Knorr, Robert Schmid, Dr Thomas Jilg (all Corporate/M&A, Berlin), Dr Silke Dulle (Medical Law), Dr Dietmar Müller-Boruttau, Wolf J. Reuter, Dr Martin Kalf (all Labour & Employment, Berlin), Helmut König (Tax, Dusseldorf)

Media Contact
Frauke Reuther
Manager Kommunikation
ADVANT Beiten
+49 (69) 75 60 95 - 570
frauke.reuther@advant-beiten.com

Klinikum Ernst von Bergmann has sold its majority stake in Lausitz Klinik Forst GmbH to the Foundation Stiftung Evangelische Diakonissenhaus Berlin Teltow Lehnin as part of a structured bidding process.

Advisors to Klinikum Ernst von Bergmann:

ADVANT Beiten: Dr Karl-Dieter Müller (Berlin, in charge), Robert Schmid, Benjamin Knorr, Dr Thomas Jilg (all Corporate/M&A, Berlin), Dr Silke Dulle (Medical Law, Berlin), Helmut König (Tax, Dusseldorf), Christoph Heinrich (Antitrust, Munich)

Media Contact
Frauke Reuther
Manager Kommunikation
ADVANT Beiten
+49 (69) 75 60 95 - 570
frauke.reuther@advant-beiten.com

Dr. Karl-Dieter Müller
Lawyer, Tax Consultant
ADVANT Beiten 
+49 30 26471-262
Karl-Dieter.Mueller@advant-beiten.com

Transaction structure

Where the target is involved in the manufacture or distribution of medical products, transaction structure will be key. As the existence and issue of product certifications directly affect the value of a company, all certifications must be properly transferred to the acquirer. This raises the question of whether a share or asset deal would better capture these characteristics. The answer to this question is not straightforward and will depend on the case.

Share deal

Generally, a share deal will be less complicated than an asset deal for transactions involving medical products. The inherent rights and obligations will transfer with the shares in the target company. This can be a significant advantage considering regulatory requirements. As the value of a medical product primarily depends on whether it has the relevant legal authorisations – such as a CE label – it is particularly important for acquirers that these authorisations transfer to the new owner. In contrast to an asset deal, the target retains its legal identity in a share deal. The manufacturer does not change, so the CE label and any other approvals and licenses remain unchanged.

The transfer is not without conditions but requires both the company and its internal organisational structure, e.g. the existing quality management system and the distribution of responsibilities with respect to product monitoring within the target company, to remain unchanged after the transfer. If processes or the organisational structure change, recertification will often be required. If the acquirer renames the company, it will necessitate recertification and an amendment to the label as it will change the name of the manufacturer.

Another advantage of a share deal is that all relationships, internal and external, remain unaffected. However, contacts can contain a change of control clause which gives a third party the right to unilaterally terminate the contract in the case of changes to the ownership structure. You should therefore examine contracts with third parties more closely, particularly where subsidies have been granted.

Asset deal

An asset deal will be more complicated than a share deal in many cases involving medical products. It requires individual assets to be carved out of the company and transferred to the acquirer.

As authorisations are tied to the manufacturer as a company, any changes to the organisational structure will make renaming necessary. Only Class I medical products are excluded from this rule; a company can certify such products itself. A time-consuming certification process can only be avoided by transferring individual sites without any changes. As such a transfer will not trigger a need to reassess the existing documents, it will be sufficient to inform the relevant authority. However, the acquirer will also be required to relabel the product accordingly. In exceptional cases, tax aspects will justify the additional costs and effort of an asset deal.

Due diligence

In the preliminary stages of a transaction, the potential acquirer should carefully examine and analyse the target for its economic, legal, tax and financial standing (so-called due diligence). Due diligence is particularly important in highly regulated markets such as medical products.

Due diligence should show the extent to which the target complies with the strict requirements of the medical device regulation and reveal any potential liability risks for the acquirer. This must identify which regulatory provisions apply to the product manufactured or distributed. Marginal differences between medical devices law and similar areas such as pharmaceutical law can make the classification difficult.

If the MDR applies, the classification of the target will play a decisive role. Depending on whether the company is active as a manufacturer, importer, or in some other role, particular legal obligations may be triggered, such as documentation requirements, or monitoring or inspection obligations. For this reason, acquirers must carefully examine whether the regulatory requirements for the certification have been fulfilled and whether they will continue to be fulfilled in the future. The sale and purchase agreement should adequately represent any risks identified during due diligence, such as with guarantees or warranties, waivers, or a reduction in the purchase price. Given the strict requirements of the MDR, it can also be advisable to make certain requirements a condition precedent.

Outlook and comments

Updates to medical devices law have exacerbated the existing difficulties of corporate acquisitions in this field. Manufacturers must consistently ensure that their products fulfil the regulatory requirements. Outside of the EU, it can be even more complicated, costly and time-consuming to transfer authorisations and licences.

If you are considering selling or acquiring a target active in this sector, you should involve specialists in the early stages to advise on the tax aspects of the transaction structure, keep an eye on the regulatory provisions, and reduce the risks of liability.

Benjamin Knorr
Andreas Scheffold

The bill regulates only the 1st pillar of the 2-pillar-model envisaged by the health ministry (in this context refer to our blog post of 13 April 2023). Thus, the draft includes, in particular, provisions regarding the protection of minors, home cultivation and the planned non-profit associations. The bill aims to contribute to an improved protection of children and minors as well as to improved health protection, to strengthen education on cannabis and prevention and to curb the black market.

In addition to the protection of minors, non-profit associations are the central issue of the bill. According to the bill, the so-called cultivation associations are allowed to have a maximum of 500 members and it is not allowed to be a member in more than one cultivation association. According to the bill, only the cultivation associations will be allowed to distribute cannabis for non-medical personal use to members only and at cost price. Distribution and cultivation are subject to strict regulations. First, you have to obtain a permit to cultivate and distribute.

Second, cultivation associations can’t sell to third parties and are restricted to selling cannabis on the internet. Third, even the type of packaging (neutral packaging or unwrapped) and the information on the package leaflets will probably be regultated.

Since the 2nd pillar envisages model regions for the legal sale of cannabis, changes in the legal provisions are likely to occur at least in the long run. Insofar, the final bill remains to be seen as well as a draft for the implementation of the 2nd pillar. The way for trading cannabis seeds is already paved in the present draft; importing cannabis seeds would be permitted for  cultivation associations and home cultivation.

Pursuant to the draft, cultivation associations are only allowed to finance themselves through membership fees. So far, there are no information on how the associations would have to be structured, membership fees, termination options and monitoring. This, in turn, can open up some creative space for the creation of cultivation associations and subsequent investments.

The draft bill also provides extensive provisions regarding cannabis for medical purposes. Cannabis for medical purposes may only be distributed in pharmacies. Importing and exporting cannabis from cultivation for medical purposes should be permissible. Insofar, the possibilities for import, export and transit are open for cannabis for medical purposes. The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) will be responsible for granting permissions. Likewise, the control of cultivation and cross-border traffic of cannabis for medical purposes is to be subject to the German Federal Institute for Drugs and Medical Devices. 

However, the bill also shows that the legislator attaches great importance to the protection of minors and the prevention of addiction. Accordingly, extensive documentation and reporting obligations are imposed on the cultivation associations. In particular, cultivation associations are to annually submit to the respective authorities comprehensive information on the quantities of cannabis and propagating material produced, dispensed and destroyed by the cultivation association in the previous year. Furthermore, the relevant authorities are to be given extensive powers to monitor the cultivation associations. 

As the above comments show, the current draft bill provides strict regulations for the planned cultivation associations and overall, for the legal cultivation and distribution of cannabis. In this respect, founding such association must be well planned and prepared in detail in order to be able to overcome the high legal obstacles of the cannabis law. In this regard, and in the context of cross-border trade in seeds as well as trade in medicinal cannabis, careful consideration of the extensive legal framework that the Cannabis Act will provide, and thus in-depth legal advice, is required. It remains to be seen in how far the draft bill will change due to the internal coordination with the other ministries and after consultation with the associations to be appropriately involved in the subject matter.

Dr Silke Dulle
Moritz Kopp
Robert Schmid

The Bavarian State government, for instance, commissioned a legal opinion regarding the compatibility of cannabis legalization with European and international law. The legal opinion by Prof. Bernhard Wegener of the University of Erlangen-Nuremberg was presented in March 2023 and found that the intended legislation of cannabis contradicted international and European law requirements, in particular, the relevant UN conventions on drug control.

There have recently also been opposite views in European jurisprudence. A legal study by the University of Nijmegen which was published in a specialist article, for example, has found that under certain circumstances the introduction of a government-controlled national license system for cannabis for consumption by a EU member state is possible under European and international law. Yet, the specialist article by the University of Nijmegen also views the UN conventions on drug control as a high - but not insurmountable - obstacle for the legalization of cannabis.

The question regarding the compatibility with European and international law has certainly played a significant part in the fact that the draft bill planned for March 2023 has not yet been presented. Instead of a draft bill, Mr. Lauterbach, the German Federal Health Minister, recently declared that the key issues presented in October 2022 had been revised. The revised key issues have now been presented by the Federal Ministry of Health.

According to the revised key issues, now a so-called 2-pillar-model ("club cultivation & regional model/CARe") is planned. Accordingly, there initially will be no unrestricted sale in licensed stores, as originally intended, at least not nationwide. This is supposed to be put into practice as a 2nd pillar for the time being only in model regions (districts/cities in several federal states according to the opt-in approach) for a project duration of 5 years under scientific supervision. Thereafter, companies will be enabled to produce, distribute and sell cannabis for consumption to adults in a licensed and state-controlled framework under the application of a geographical limit. However, this offers the first opportunity to enter a legal cannabis market in Germany. ADVANT Beiten will be happy to support you with our expertise in this regard.

The 1st pillar, in contrast, provides, in addition to a limited penalty-free cultivation of cannabis, that non-profit associations (up to 500 members) are allowed to grow cannabis for consumption collectively under a narrow, clearly defined legal framework and distribute it to their members for their own final consumption. The nature, structure, financing, etc. of this association will still have to be discussed and will require legal review and, in the future, legal support for the process of establishing such associations. ADVANT Beiten offers the necessary knowledge to accompany this process. The cannabis may only be distributed to members and not to third parties. Additionally, penalty-free possession for own consumption of up to 25 grammes is supposed to be possible. However, it is open whether these intended regulations will actually lead to a curbing of the black market. Here, the draft bill remains to be waited for.

The revised Key Issues Paper further provides with regard to the concerns under European and international law that the proposed regulations regarding the 1st pillar should be formed in such a way that no notification requirement and no requirement of consent by the Federal Council (Bundesrat) is triggered. However, it is still assumed that there will be a notification requirement for the proposed regulations regarding the 2nd pillar.

In addition to the questions of European and international law, the consequences of legalization under criminal law will also be discussed. The German Federal Constitutional Court (Bundesverfassungsgericht, BVerfG) could soon make a decisive contribution in this matter. The BVerfG announced that it will decide on various judges' submissions on criminal law provisions in the German Narcotics Act (Betäubungsmittelgesetz, BtMG) which concern the cannabis ban until early summer 2023. In this respect, the BVerfG could even pre-empt politics and legislation and, thus, bring new momentum into the matter, perhaps even opposing the revised key issues paper.

Not only politics and jurisprudence have been eagerly awaiting the draft bill, but also the business community. Medium-sized companies and start-ups see new business opportunities in the legalization of cannabis, but of course also companies from countries where the legalization of cannabis is already more advanced. Initial considerations assumed a turnover of 1.2 to 2.3 billion euros per year that could be generated due to legalization. From the point of view of the Federal Republic of Germany, this alone would have had the side effect of an estimated EUR 350 million in additional tax revenue just from the sales tax on legal sales. Here, it remains to be seen how the key issues will be legally implemented and finally how the "project" model regions will develop. Nevertheless, Germany will open a new cannabis market soon, creating new opportunities for companies to enter another cannabis market, for the production and sale of cannabis, to establish new companies or to acquire existing companies. In all of this, ADVANT Beiten has a competent team to provide legal support and assistance in the implementation of these new opportunities.

A first draft bill for the 1st pillar of the 2-pillar-model is to be presented before the end of April, and then the draft bill for the 2nd pillar.

As many details are still unclear, anyone wishing to enter this market should seek advice early on.

Dr Silke Dulle
Moritz Kopp
Robert Schmid

Based on proprietary platform technologies, Ethris has been developing mRNA therapeutics for diseases with inadequate treatment and for regenerative medicine for more than 10 years. The biotechnology company develops highly effective mRNA-based drugs for administration directly into the upper and lower respiratory tract and by intra-muscular injection.

Cipla is India's third-largest pharmaceutical company and South Africa's third-largest generic drug manufacturer. It has a particular focus on drugs and therapies for respiratory diseases. Cipla became internationally known for its production of low-cost HIV medicines. Founded in 1935, Cipla employs about 23,000 people.

ADVANT Beiten has a strong positioning in the healthcare sector and in advising international clients on investments in the German market.

Advisor Cipla Ltd.:
ADVANT Beiten: Christian Hipp (Antitrust), Benjamin Knorr (Corporate/M&A and Tax, both leading advisors, Berlin), Dr Dietmar O. Reich (Antitrust, Hamburg and Brussels), Wolf J. Reuter (Employment, Berlin), Robert Schmid(Corporate/M&A, Berlin), Dr Christian Ulrich Wolf (Corporate/M&A, Hamburg), Christian Hess (IP/IT, Munich).

Advisor Ethris GmbH:
m law group. Munich

Media Contact
Frauke Reuther
Manager Kommunikation
ADVANT Beiten
+49 (69) 75 60 95 - 570
frauke.reuther@advant-beiten.com

Benjamin Knorr
Rechtsanwalt
ADVANT Beiten
+49 (30) 26471 – 262
benjamin.knorr@advant-beiten.com

The Federal Association for Medical Devices ("BVMed") recently emphasised that around 30% of medical devices could therefore 'disappear' from the market because the new regulatory system of the MDR lacks the capacity to certify existing products in due time and the documentation effort for existing products has increased dramatically. This concerns various products, such as surgical materials, but also plasters, glasses and rapid antigen tests.

These problems arising out of the implementation of the MDR were discussed at detail at the EPSCO meeting held by the health ministries of the European member states on 14 June 2022. A solution to the problems is however not at sight. While the postponement of deadlines and the expansion of resources at the notified bodies are being discussed, legal adjustments or amendments to the MDR do not yet exist.

It is therefore important to have existing products recertified in a timely manner.
Please feel free to contact us now if you have any questions.

Moritz Kopp
Dr Silke Dulle

The ADVANT Beiten team around lead partner Dr Sebastian Weller provided full support for the complex transaction across practice groups and offices: from the preparation and structuring of the transaction (including due diligence), to the negotiation, implementation and closing of the transaction including antitrust notification.

Medline is a leading global healthcare company that manufactures and distributes high-quality medical and surgical products. Medline Europe was founded in 2011 and operates branches, as well as production and distribution centres throughout Europe.

Asid Bonz is a leading supplier to clinics and hospitals in Germany, offering high-quality products for surgery, anaesthesia, ward care and urology. Asid Bonz was founded in 1811 and is known worldwide for having developed the first anaesthetic ether. In 2021, Asid Bonz achieved a turnover of more than 30 million euros and supplied more than 1,100 hospitals in Germany.

With similar business models and excellent customer service, the two companies are an excellent strategic fit. In the future, Medline will make the Asid Bonz brand available to its broad European customer base outside of Germany. Within Germany, Asid Bonz sales representatives will have access to selected Medline products to further expand their partnership with customers.

Advisor to Medline International B.V.:
ADVANT Beiten: Dr Sebastian Weller (Corporate/M&A, in charge), Nico Frielinghaus (Corporate/M&A), Dr Tassilo Klesen (Corporate/Commercial), Markus Schönherr (Corporate/M&aA), Dr Patrick Hübner (Investment Control), Peter Weck (Labour Law), Dr Andrea Pomana (Antitrust), Christoph Heinrich (Antitrust), Marco Mirceta (Antitrust), Mathias Zimmer-Goertz (IP), Christian Döpke (Data Protection), Dr Marion Frotscher (Tax), Simon Bauer (Tax), Katrin Lüdtke (Public Law), Sascha Opheys (Subsidies).

Advisor to Medi-Globe Europe:
White & Case: Dr Stefan Koch, lead partner

Media Contact
Frauke Reuther
Manager Kommunikation
ADVANT Beiten
+49 (69) 75 60 95 - 570
Frauke.Reuther@advant-beiten.com

Dr Sebastian Weller
Lawyer
ADVANT Beiten
+49 (211) 51 89 89 - 134
Sebastian.Weller@advant-beiten.com

The Regulation deviates from the draft bill to some extent. Many of the changes are of a purely editorial nature. In some cases, however, the provisions have been specified even more in order to specifically limit the scope of the standards. More extensive adjustments of content have also been carried out, for example, in the exceptions to the German Transfusion Act (Transfusionsgesetz) (section 5 MedBVSV), the German Pharmaceuticals Act Cost Regulation (AMG-KostV) (section 6 MedBVSV) and the Cost Regulation for any official acts of the Paul Ehrlich Institute under the German Pharmaceuticals Act (AMG) (section 7 MedBVSV). It is particularly noticeable in the case of sections 6 and 7 that the regulations are no longer merely optional provisions, but that the charging of fees is now waived in the corresponding cases if the subject matter is a drug for the treatment, prevention or diagnosis of COVID-19. In the draft bill, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute were still responsible for deciding if the charging of fees would be waived.

Section 9 MedBVSV forms ‑ as already in the draft bill ‑ the legal basis for facilitating the placing on the market of personal protective equipment (see also our post dated 2 April 2020). In comparison to the draft bill, almost only editorial adjustments were made here. Section 9 (1) MedBVSV now also includes that the marketable products are made available on the German market by an "economic operator in terms of Article 3 (8) of Regulation (EU) 2016/425". The standard is thus further specified.

Dr Silke Dulle

Robert Schmid

The purpose of the Act is mainly to protect people particularly vulnerable to infection with the coronavirus and to gain a better insight into the course of the pandemic. Among other things, the Act establishes that the Federal Ministry of Health (BMG) is authorised to issue a regulation obliging statutory health insurance companies to generally pay for coronavirus or antibody tests. Furthermore, the public health service will be supported by federal measures, in particular to promote digitisation (EUR 50m will be made available for this purpose). In view of the recently enacted Digital Health Applications Ordinance (see our blog post of 28 April 2020), this is another step towards the digitisation of the health care system. As with the European Commission's announcement that the EU Medical Devices Regulation (EU) 2017/745 will be postponed to 2021 (see also our blog post from dated 1 April 2020), the Act also postpones the entry into force of the new Medical Devices Implementation Act by one year, and the Medical Devices Act will now apply one year longer, until 26 May 2021.

The corresponding communication of the Federal Ministry of Health with further explanations as well as the draft bill and the recommendation for a resolution (all of them in German) can be obtained through the following links:

Communication of the Federal Ministry of Health

Draft bill

Recommendation for a resolution

Dr Silke Dulle

Robert Schmid

The DVG came into force on 19 December 2019. It has thus created the basis for the insured persons' entitlement to benefits from the provision of digital health applications. Among other things, the DVG has made amendments to the German Social Code Book V (Fünftes Buch Sozialgesetzbuch, "SGB V"). For instance, section 33a SGB V was newly included which defines digital health applications in legal terms. According to the amended section 33a (1) of SGB V, insured persons are entitled to be supplied with low-risk medical devices whose main function is essentially based on digital technologies and which are intended to support the detection, monitoring, treatment or alleviation of diseases or the detection, treatment, alleviation or compensation of injuries or disabilities among the insured persons or in the care provided by service providers. Medical devices of low risk class are those that are assigned to risk class I or IIa in accordance with the EU Medical Devices Regulation (EU) 2017/745. Digital health applications are thus to be considered as medical devices in the sense of section 33a SGB V. As a consequence, the regulations of medical device law must first be observed, in particular the implementation of a conformity evaluation procedure in accordance with the Medical Device Directive 93/42/EEC, which is still in force, and the EU Medical Device Regulation which will be in force as of 26 May 2021. For medical devices of risk class I as defined by the EU Medical Devices Regulation, the conformity evaluation procedure can be carried out by the manufacturer himself.

The claim according to section 33a (1) SGB V only covers those digital health applications which have been included by the Federal Institute for Drugs and Medical Devices ("BfArM") in the directory for digital health applications according to the also newly included section 139e SGB V and which are used either according to the prescription of the attending physician or with the approval of the health insurance company. Section 139e (1) SGB V stipulates that the BfArM maintains a directory for reimbursable digital health applications according to section 33a SGB V. The respective directory is published in the Federal Gazette. Pursuant to section 139e (2) SGB V, the medical device in question is included in the directory upon electronic application by the manufacturer to the BfArM, which has to decide on the application within three months of receipt of the complete application pursuant to section 139e (3) SGB V.

The DiGAV also came into force on 21 April 2020. Among other things, the DiGAV sets out the requirements to be met by digital health applications for inclusion in the directory, particularly with regard to security, quality, data protection and data security (cf. sections 3 to 6 DiGAV) and determines the procedure for inclusion of the relevant medical device in the directory for digital health applications. According to this, the safety and functionality of the digital health application is proven in particular by the CE conformity marking in the sense of the medical device law (also see our contribution to Placing on the market of medical devices in the course of the corona crisis). The BfArM may carry out additional examinations for substantiated reasons, e.g. demand the submission of further documents, in particular the declarations and certificates necessary for the conformity evaluation procedure. Furthermore, BfArM may require the manufacturer to submit certificates confirming that the requirements pursuant to sections 4 to 6 DiGAV have been met, insofar as corresponding certificates are provided for on the basis of safety, quality or environmental standards or other recognised certificates are suitable as proof of the requirements. The certificates must not be older than twelve months. Pursuant to section 7 (2) DiGAV, the certificates must have been issued by an appropriately qualified and recognised certification body. A further prerequisite for inclusion in the directory is the provision of evidence of positive supply effects. According to section 8 (1) DiGAV, positive healthcare effects are either a medical benefit or structural and procedural improvements in healthcare relevant to patients. In accordance with section 10 DiGAV, the manufacturer must submit a comparative study as evidence.

Together with the DiGAV, Guidance document of the BfArM has also been published. The guidance document offers a summary of the regulations of DVG and DiGAV and illustrates with examples when a registrable digital health application in the sense of the legal regulations is at hand. Among other things, the guidance document addresses the fact that digital health applications serve to support the detection, monitoring, treatment or alleviation of diseases or the detection, treatment, alleviation or compensation of injuries or disabilities. Accordingly, primary preventive digital health applications cannot be listed in the directory according to section 139e SGB V, since primary prevention serves to prevent the development of diseases and not to detect or treat them. The guidance document also illustrates the basic application procedure and explains that the procedure is designed as a fast track. The BfArM has to assess the product within the three-month period according to section 139e (3) SGB V. If the requirements for safety, quality, data protection and data security are met and if there are positive supply effects, the BfArM must include the digital health application in the directory. In this context, evidence of safety and functional capability is generally deemed to have been provided upon successful completion of the conformity evaluation procedure. If only the positive effects of supply are not proven, provisional inclusion in the directory can be granted upon application which triggers a test phase of up to one year during which the necessary comparative study is to be carried out.

Dr Silke Dulle

Robert Schmid

The Regulation deviates considerably from the draft bill in some sections. The selling and commitment ban in section 8 of the draft bill is now regulated in section 7 of the SARS-CoV-2 Pharmaceuticals Supply Regulation. The obligation of manufacturers and distributors to provide information, which is regulated in section 8 (2) of the draft bill, has been adopted and extended to include information on the storage location of the products concerned, section 7 (1) of the SARS-CoV-2 Pharmaceuticals Supply Regulation.

The initially envisaged authority of the Federal Ministry of Health ("BMG") to issue a ban on the sale of products of medical need was deleted. The regulation provided for in the draft bill that a ban can also extend to other obligations to supply as well as to the supply to fulfil obligations already undertaken was also not adopted. Rather, section 7 (2) of the SARS-CoV-2 Pharmaceuticals Supply Regulation stipulates that manufacturers and distributors of products of medical need relevant to healthcare must ensure, within the scope of their responsibility and what is reasonable for them, an adequate and continuous supply of products of medical need relevant to healthcare so that the needs of the population within the scope of the Regulation are covered. The prices of such products must be based on the costs of provision, and manufacturers and distributors may not impose surcharges on consumers on account of the epidemic situation of national dimensions. Also, the concept of "Factual circumstances relating to products of medical need relevant to the provision of healthcare" was newly introduced in section 7 (3). According to this provision, products of medical need relevant to the provision of healthcare are pharmaceuticals, their active substances, starting materials and auxiliary materials, medical products, laboratory diagnostics, auxiliary materials, items of personal protective equipment, products for disinfection and their individual components, for which the BMG has determined that they are of essential importance for the provision of care to the population in an epidemic situation of national dimensions. The respective statements are published in the Federal Gazette.

Section 5 (2) no. 6 of the German Infection Protection Act must be observed. Accordingly, the BMG is authorised to issue the necessary orders to implement the measures regulated in the enacted regulations. Thus, the BMG can issue orders to ensure that the obligations of manufacturers and distributors as defined in section 7 of the SARS-CoV-2 Pharmaceuticals Supply Regulation are fulfilled. As a result, corresponding selling and commitment bans can be ordered. In order to protect manufacturers and distributors from any damage caused by this, section 7 (2) of the SARS-CoV-2 Pharmaceuticals Supply Regulation provides for a reimbursement claim for manufacturers for expenses incurred if, as a result of an order pursuant to section 5 (2) no. 6 of the Infection Protection Act, they are no longer in a position to fulfil their obligations arising from contractual relationships already entered into. Accordingly, the manufacturer or distributor may claim reimbursement of the expenses they have to bear in relation to the other contracting party.

Dr Silke Dulle

Robert Schmid

1. Draft bill of SARS-CoV-2 Pharmaceutials Supply Regulation of 8 April 2020

Based on the authorization to issue regulations pursuant to the revised section 5 (2) Infection Protection Law (IfSG) the BMG on 8 April 2020 announced the SARS-CoV-2-Pharmaceuticals Supply Regulation and published the relevant draft bill (Draft Bill). Inter alia, the Regulation in § 8 provides for a selling and commitment ban for products of medical need. Pursuant to section 8 (4) of the Regulation products of medical need include also medical products and PPE. Pursuant to section 8 (1) of the Regulation the BMG may order that products of medical need are subject to market control and monitoring by the BMG. Pursuant to section 8 (2) of the Regulation manufacturers and distributors of products accordingly monitored and controlled are obliged to provide the BMG or an authority designated by the latter with information abut the stocks, production, distribution and the prices of the products of medical neet forthwith and at any time. Furthermore, pursuant to section 8 (3) of the Regulation the BMG is authorized to restrict the trade with controlled products and to provide for further details for the distribution and price fixing. The BMG may prohibit the sale or other commitment to provide products of medical need as well as the provision of products for the performance of obligations already incurred, to the extent that this is required to secure the supply of the population. The BMG may order that products, which are subject to a ban pursuant to section 8 (3) of the Regulation, have to be sold to the Federal Republic of Germany, a Federal State or a community or other legal or private person specified at a price to be fixed by public authorities.The price fixed by public authorities shall be based on the normal selling price of the product the latter had prior to the determination of the epidemic situation. Violations of the selling and commitment ban may be punished as administrative offence (sectio 73 (1)a No. 24 IfSG).

Pursuant to the draft bill the selling and commitment ban is justified as follows. The provision with products of medical need might also be jeopardized due to the fact that manufacturers of those products enter or entered into other contractual obligations. The bans prevent the primary performance of other obligations and make it possible that the products can be used for the fight against the pandemic situation caused by the coronavirus SARS-CoV-2. The possibility of ordering that relevant products have to be sold to certain legal or private persons at a price to be fixed by public authorities would be required to guarantee that these products are used appropriately.

The Regulation also provides for further rules concerning deviations from Volume 5 of the Social Insurance Code, the Pharmacy Act, the Pharmacies Operation Regulation, the Pharmaceutical Prescription Regulation, the Narcotics Act and the Narcotics Prescription Act.

The Regulation will cease to be in force upon annulment of the finding of a nation-wide epidemic situation, however, upon lapse of 31 March 2021 at the latest.

2. Draft Bill of Medical Needds Suppy Securing Regulation of 14 April 2020

On the basis of the authorization to issue a regulation the BMG announced the MedBVSV and the draft bill (Draft Bill).  Inter alia, the Regulation enables the central provision of products of medical need by the Federal Government for the supply of the population during the coronavirus epidemic. Pursuant to section 1 (2) MedBVSV medical products and PPE are products of medical need.

In section 9 the MedBVSV further determines a legal basis which is meant to facilitate the marketing of personal protective equipment ("PPE"). Accordingly, pursuant to section 9 (2) of the Regulation, PPP within the meaning of the Regulation (EC) 2016/425 ("PPE-Regulation") can be made available on the German market - even if marketability is not given or cannot be determined - in deviation from the provisions of the PPE-Regulation if in an evaluation procedure by a notified authority on the basis of an evaluation principle published by the Central Agency of the Federal States for Safety Technology ("ZLS") it has been established that the PPE offers a health and safety level similar to the basic requirements of the PPE-Regulation. Thus, also PPE without CE-label can be considered as marketable by the market control and monitoring authorities if the suitability of the PPE is confirmed by an appropriate evaluation procedure. Such an abridged procedure is, inter alia, the procedure for respiratory masks developed by DEKRA and IFA (see our Article of 2 April 2020). Further abridged evaluation procedures might follow and will be published on the website of ZLS (LINK). The justification of the law regardig section 9 (2) MedBVSV also refers to the fact that the abridged evaluation procedure does not replace a conformity assessment pursuant to the PPE-Regulation.

In addition to the PPE within the meaning of section 9 (2) MedBVSV, now, pursuant to section 9 (1) MedBVSV, also PPE marketable in the USA, Canada, Australia and Japan may be made available on the German market. The competent market control and monitoring authority decides on its marketability.

To secure that PPE within the meaning of section 9 (1) and (2) MedBVSV is traceable and cannot be confused with compliant PPE under the PPE-Regulation pursuant to section 9 (3) the PPE has to be provided with an official confirmation which has to be added to each selling unit and indicates that the equipment is PPE which is made available according to the provisions of the MedBVSV.

Furthermore, the MedBVSV regulates exemptions from the Pharmaceuticals Act, e.g. exemptions from the Pharmaceuticals Act, the Pharmaceuticals Trading Regulation, the Transfusion Act and from the GCP-Regulation.

The Regulation will cease to be in force upon annulment of the finding of a nation-wide epidemic situation, however, upon lapse of 31 March 2021 at the latest.

3. Conclusion

With the new regulations the BMG reacted to the recommendation of the EU-Commission of 13 March 2020 and established legal fundamentals which, inter alia, facilitate the marketing of, at present, urgently required PPE. In so doing, the BMG followed the exemption rules proposed by the EU-Commission in its recommendation (see in this respect our Article of 15 April 2020 ) so that it is now possible to provide for the German market also PPE without having executed the conformity evaluation procedure and without CE-label. Due to the non-legally binding nature of recommendations of the EU-Commission (Art. 288 TFEU) an appropriate legal basis was necessary to create legal certainty. Pursuant to the justification of the MedBVSV, this Regulation is also in line with EU-law, since in times of crisis national measures in the field of the products of medical need are justified by the primary right of Union law (see Art. 168 (7) TFEU).

Dr Silke Dulle

Robert Schmid

1. Export Restrictions on Personal Protective Equipment du to the Comission Implementing Regulation (EU) 2020/402 of 14 March 2020

On 14 March 2020 the European Commission adopted the Implementing Regulation (EU) 2020/402 on the making the exportation of certain products subject to the production of an export authorisation. The Regulation has entered into force on 15 March 2020 (LINK). The Regulation will apply for six weeks. According to the Regulation, the export of personal protective equipment is subject to an authorisation. An export authorisation is required regardless of whether the goods originate in the European Union or not. It is required for protective spectacles and visors, face shields, mouth-nose-protection equipment, protective garments and gloves. In Germany, an application for export authorisation must be made at the Federal Office of Economics and Export Control (Bundesamt für Wirtschaft und Ausfuhrkontrolle). The export ban applies to all non-EU countries. The states of Norway, Iceland, Liechtenstein and Switzerland are excluded from the scope of the Implementing Regulation (EU) 2020/402 (LINK). This also applies to overseas countries and territories, the Faroe Islands, Andorra, San Marino and Vatican City.

The Federal Ministry for Economic Affairs and Energy had already ordered on 4 March 2020 and 12 March 2020 that the export of relevant personal protective equipment is prohibited.  This also applied to exports to other EU states. On the basis of the Implementing Regulation (EU) 2020/402, the Federal Ministry for Economic Affairs and Energy revoked the order on 19 March 2020.

2. Guidelines of the European Commission dated 27 March 2020

On 30 March 2020 the European Commission has published Guidelines on Conformity Assessment Procedures for Protective Equipment dated 27 March 2020 (LINK). The guidelines are addressed to prospective manufacturers of protective equipment. According to the European Commission, they will be complemented on a regular basis.

The EU Commission states in the Guidelines that masks and other equipment used in the COVID-19 context that are covered by the PPE Regulation are considered as 'PPE of Category III'. Therefore, a notified body must be involved in all cases which will test the product prior to placing on the market (conformity assessment procedure).

The Guidelines further refer to the recommendation issued by the Commission on 13 March 2020 and explain the exceptions proposed in the recommendation when PPE may be already placed on the market even if the conformity assessment procedures have not yet been finalised or even initiated:

• If national market surveillance authorities find that equipment in the EU market ensure an adequate level of health and safety in accordance with the essential requirements set out in EU law, they may authorise these products on the EU market, even though the conformity assessment procedures, including the affixing of CE marking, have not been fully finalised.
   
• In exceptional circumstances, products can be placed on the market even if the certification procedures have not been initiated and no CE marking has been affixed upon them, if the following cumulative conditions are fulfilled:
   
• The products are manufactured in accordance with one of the EN standards or in accordance with any of the other standards referred to in the WHO guidelines or a technical solution ensuring an adequate level of safety;
• the products are part of a purchase organised by the relevant Member State authorities;
• the products are only made available for the healthcare workers;
• the products are only made available for the duration of the current health crisis; and
• the products are not entering the regular distribution channels and made available to other users. 

The Guidelines further refer to the shortened testing procedures for respiratory masks developed by DEKRA and IFA. In this regard, the Central Office of Federal States for Safety Technology (Zentralstelle der Länder für Sicherheitstechnik) pointed out in its communication dated 1 April 2020 that this accelerated testing procedure does not, however, constitute a conformity assessment in accordance with the PPE Regulation and is not intended to replace it (LINK). However, the successful completion of the accelerated testing procedure can be used as a basis for the decision of the competent authorities with regard to the exceptions proposed in the recommendation of the EU Commission.

3. Regulation of 8 April 2020 on the Procurement of Medical Devices and Personal Protective Equipment

In the course of the Recommendation and the Guidelines of the European Commission, the Federal Ministry of Health ("BMG") has initiated an open-house procedure as an organised procurement process. Under this procedure, the BMG purchases protective equipment at a fixed price and distributes the products to the federal states of Germany and health insurance associations. The subject of this procedure is the conclusion of supply contracts for protective equipment. As part of such organised procurement procedures, the BMG issued the "Regulation on the Procurement of Medical Devices and Personal Protective Equipment for the Epidemic Caused by the Coronavirus SARS-CoV-2" which came into force on 10 April 2020(LINK). Under the Regulation the Federal Republic of Germany is an importer of medical devices and personal protective equipment within the meaning of the Medical Devices Act (MPG) and the PPE Regulation, if it has medical devices or personal protective equipment brought into the territory of the Federal Republic of Germany as part of a procurement programme commissioned since 27 March 2020. The natural or legal persons commissioned by the Federal Republic of Germany with the introduction are not themselves importers. Along the lines of the Recommendation and Guidelines of the EU Commission, the Regulation also stipulates that the products imported within the scope of the procurement procedure may only be sold to the group of persons designated by the Federal Ministry of Health. They may not be put into circulation via the usual distribution channels for these products and may not be sold to any other group of persons than the group of persons determined by the Federal Ministry of Health. In addition, the Regulation stipulates that the provisions also apply accordingly if a federal state, in coordination with the Federal Ministry of Health, has medical devices or personal protective equipment introduced to Germany as part of a procurement programme commissioned by it since 27 March 2020. In this case, the federal state is an importer within the meaning of the Medical Devices Act (MPG) and the PPE Regulation.

Dr. Silke Dulle

Robert Schmid

1. Marktability of PPE

Products can be marketed as PPE if the conditions prescribed by law are fulfilled. The requirements for the placing on the market of PPE are regulated in the PPE Ordinance and the PPE Implementing Act ("PSA-DG"). The PPE ordinance is directly applicable in Germany. According to these, a CE mark must be affixed to the product so that the product may be placed on the market. In accordance with Article 8 (2) in conjunction with Article 19 PPE Ordinance, the prerequisite for the CE marking is the implementation of the prescribed conformity assessment procedure. Here a distinction is made between three categories in accordance with Article 19 PPE Ordinance. The conformity assessment procedure is carried out by the manufacturer himself in the case of category I PPE and by notified bodies in the case of category II and III PPE. Accordingly, a PPE product has to overcome similar obstacles to marketability as is the case with medical devices.

2. Recommendation of the European Commission

In its Recommendation (EU) 2020/403 of 13 March 2020 the European Commission (EU Commission) has now presented measures to accelerate and simplify the procedures for the distribution of medical devices and PPE. According to the recommendation, it will in particular be possible to place medical devices and PPE on the market without CE marking. or PPE, the EU Commission proposes that the responsible market surveillance authorities evaluate the PPE products. Where products are found to be in conformity with the essential health and safety requirements of the relevant legislation, the market surveillance authorities are to take action to allow the placing on the market of such products for a limited period of time or while the conformity assessment procedure is ongoing. However, it must be ensured that products without CE marking are only made available to healthcare professionals, and only for the duration of the current health threat. Furthermore, the EU Commission recommends that the notified bodies give priority to the conformity assessment of newly submitted applications for PPE necessary for protection in connection with the outbreak of COVID-19 and carry it out rapidly. In this context, the EU Commission has determined, in addition to the previously harmonised standards, that the recommendations of the WHO can be used as a reference for other technical solutions, provided that an adequate level of protection is guaranteed. If notified bodies accept other technical solutions than the harmonised standards, they should immediately inform the notifying authority and other notified bodies of this possibility.

3. Implementation of the recommendation

A recommendation of the EU Commission is, however, not binding under Art. 288 TFEU. In contrast to medical devices, for which special approvals can be granted without carrying out the conformity assessment procedure in accordance with section 11 (1) German Medical Devices Act (MPG), there is no comparable regulation either in German law or in the PPE Ordinance. Rather, the placing of PPE on the market without carrying out a conformity assessment procedure or without CE marking can be fined, see section 8 PSA-DG.

The implementation of the conformity assessment procedure can be simplified or accelerated. According to Article 14 of the PPE Ordinance, PPE products which conform to harmonised standards or parts thereof are presumed to conform to the essential health and safety requirements. This legally disputable presumption shortens the conformity assessment procedure so that rapid market access can be facilitated. The EU Commission also appears to be seeking to create further harmonised standards which can then be referred to in the assessment procedure.

4. Protective masks without CE marking

An accelerated assessment procedure alone will probably not be sufficient to provide healthcare professionals with sufficient protective masks. In its recommendation of 13 March 2020, the EU Commission therefore proposes that protective masks should also be procured without CE marking, provided that it is ensured that these products are only made available to healthcare professionals and only for the duration of the current health threat. They must also ensure an adequate level of health and safety. In particular, the protective masks shall not enter the normal distribution channels. On 18 March 2020, the Federal Institute for Occupational Safety and Health ("BAuA") issued In the course of this the recommendation Recommendation to use masks for employees in the medical and care sector that comply at least with the NIOSH Standard N95. This means that protective masks that would be marketable in the USA, Canada, Australia and Japan are also considered marketable in Germany, even if no CE marking is present.

According to the BAuA, if a marketability is still not given after that, a notified body must check in individual cases whether the masks comply with the EU protection standard. DEKRA Testing and Certification GmbH ("DEKRA") and the Institute for Occupational Safety and Health ("IFA") have already developed one Audit principle in this context which makes it possible to determine within a few days whether the respective products guarantee an adequate level of health and safety. There is good reason to believe that once this testing principle has been carried out, the products can be used as protective masks in accordance with the recommendation of the Commission. DEKRA itself, however, points out that the masks tested in accordance with its auditing standards are not PPE in accordance with the PPE Ordinance. However, the Commission justifies the audit principle developed with under the recommendation of the EU Commission.

5. Conclusion

Measures are being taken at both EU and national level to meet the high demand for protective equipment. In light of the fact that recommendations of the EU Commission are not binding, for reasons of legal certainty it is questionable how, for example, masks without CE marking and without carrying out the conformity assessment procedure can be placed on the market as protective masks. This could also be of relevance with regard to the administrative offence provision in section 8 PSA-DG, whereas the actual prosecution of a possible administrative offence under section 47 (1) German Administrative Offences Act (OWiG) is at the discretion of the prosecuting authority. Due to the current amendment of the Infection Protection Act in section 5 (2) no. 4, it is obvious that the Federal Ministry of Health will create a legal basis in the short term by means of corresponding ordinances in order to comply with the recommendations of the EU Commission with regard to products such as protective masks. In this context, further legislation at EU level could also provide more legal certainty.

Dr. Silke Dulle

Robert Schmid

With its recommendation (EU)2020/403 of 13 March 2020, the European Commission (EU Commission) presented measures to accelerate and simplify the procedures for the distribution of medical devices and personal protective equipment. However, a recommendation of the EU Commission is, pursuant to Article 288 TFEU, not binding, so that implementation requires corresponding national legislation.

The prerequisites for the placing on the market of medical devices are regulated in German law in the German Medical Devices Act (MPG) and the corresponding regulations to the MPG in conjunction with the relevant EU directives. According to these, a CE mark must be affixed to the product so that the product may be placed on the market. This does not apply to medical devices with a special approval pursuant to Section 11 (1) MPG and in-vitro diagnostics intended for performance evaluation purposes. Prerequisites for the CE marking are the fulfilment of the basic requirements according to Section 7 MPG and the execution of the prescribed conformity assessment procedure. The conformity assessment procedure is carried out by notified body or notified institutions.

In order to address the current high demand for appropriate medical devices and personal protective equipment (PPE), the EU Commission's recommendation provides for measures to ensure that medical devices are made available on the market more quickly. In particular, manufacturers should now be able to place products on the market in exceptional cases without the otherwise required CE marking. In the case of medical devices, member states should therefore consider allowing exceptions to the conformity assessment procedures. However, it must be ensured that products without CE marking are only made available to healthcare professionals, and only for the duration of the current health threat.

In Germany, the provision under Section 11 (1) MPG allows compliance with the recommendation of the EU Commission for medical devices. According to this provision, the Federal Institute for Drugs and Medical Devices (BfArM) can grant temporary special approvals for medical devices upon request for health protection purposes. In view of current events in connection with the coronavirus, the Institute for Drugs and Medical Devices believes that the granting of special approvals is in the interest of health protection. Thus the mandatory requirement of Section 11 (1) MPG is met (read here). Accordingly, special approvals can be granted for rapid tests, medical respiratory masks etc.

The application for a special approval is made informally. We recommend prior consultation with the Institute for Drugs and Medical Devices BfArM. The application must be demonstrate that the products in question meet the relevant safety and performance requirements such as those of the applicable technical standards. In the case of an application for a rapid test, the applicant must in particular prove sufficient sensitivity and specificity by appropriate documentation.

Please note that the MPG shall cease to be in effect as of 26 May 2020. It will be replaced by the Medical Devices EU Adaptation Act (MEPUAnpG) which was passed by the German Bundestag on5 March 2020 to adapt medical device law to the Medical Devices Directive (EU) 2017/745 ("MDR"). The Federal Council (Bundesrat) approved the law on 27 March 2020. In accordance with Section 7 in conjunction with Section 85 EPUAnpG, also the MEPUAnpG authorizes the Institute for Drugs and Medical Devices, BfArM, to grant special approvals for medical devices. According to the explanatory memorandum, the new Section 7 MEPUAnpG corresponds to Section 11 MPG. The link to the draft law for the MEPUAnpG can be found here. However, in view of current developments, there is a discussion at EU level to postpone the entry into force of the MDR by one year, so that the MEPUAnpG might also not come into force until 2021. The MDR is accompanied by tightening measures such as unannounced inspections and stricter tests of the notified bodies, so that the regulations would be counterproductive for facilitating the marketing of medical devices.

Due to the current amendment to the Protection Against Infection Act (IfSG), the Federal Ministry of Health is furthermore authorised pursuant to Section 5 (2) no. 4 InfSG to take measures for the distribution of medical devices by issuing statutory regulations, in particular to permit exceptions to medical device regulations governing the manufacture, marking, approval, clinical testing, use, prescription and dispensing, import and export, introduction and liability. Such measures are compatible with EU law with regard to Article 59 MDR. According to this, it may be necessary to allow exceptions in the interest of public health and in order to ensure supply. In this respect, legal regulations could be issued in a timely manner to further facilitate the placing on the market of medical devices, at least temporarily, such as exemptions from the conformity assessment procedure.

Dr Silke Dulle
(Lawyer, Licensed Specialist for Medical Law)

Robert Schmid
(Lawyer, LL.B.)

• BT-Drs. 19/18112
• BT-Drs. 19/18111
• Krankenhausentlastungsgesetz
• Gesetz zum Schutz der Bevölkerung bei einer epidemischen Lage von nationaler Tragweite

If you have any questions on this topic, please contact Dr. Karl-Dieter Müller, Dr. Silke Dulle and Robert Schmid.