Legal regulations

Bavarian Government - Dr. Schrubar and Dr. Müller

Contact persons of the Bavarian government for regulation of gene technology

To get a first idea about laws and regulations concerning our BaKillus system, we contacted Dr. Schrubar and Dr. Müller from the Bavarian government. They advise citizens and companies on the regulatory framework of gene technology. In our meeting, they provided us with a general overview on the legislation applying to BaKillus. We learned about the difference between "drugs" and "medical products", the difficulties of clinical trials and studies prior to release to the environment. Additionally, they established contact to the next steps of our expertise journey.

Prof. Dr. Jörg Hasford

Professor for Medical Information Processing, Biometry and Epidemiology at the Ludwig Maximilian University of Munich
Co-chairman of the „Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e.V.“

Main concerns:

• How does the admission procedure for drugs work? What are the relevant authorities?
• Which ethical aspects have to be considered regarding BaKillus?

What we learned:

• Overview about admission procedure primarily at national level and current legal requirements
• Personal contacts to several authorities involved in drug approval
• Detailed information about the work and responsibility of ethics commissions in the design and implementation of clinical trials

In late July 2014 a delegation of our team had the great pleasure to meet Prof. Dr. Jörg Hasford at the University Hospital Großhadern after listening to his very interesting and for our project highly useful talk at the „Medizin Innovativ – MedTech Pharma 2014“ Congress in Nuremberg. After a short overview about the iGEM competition and all its facets, we introduced our BaKillus project and our idea of using BaKillus as a nasal spray. We were really excited of getting feedback from an expert with medical background and were delighted to hear that in his opinion too, there is an pressing need for new and innovative therapies against multi-resistant bacteria. He explained that our BaKillus spray would be defined as a drug and not as medical device since BaKillus interacts with the environment on chemical levels. Therefore our nasal spray has to adhere to the drug law of the particular country or community of states. He further outlined the milestones every new drug has to achieve – starting from preclinical evaluation over different clinical phases to application for marketing authorisation – which is only possible through close collaborations with the responsible authorities. Fortunately Prof. Hasford could refer us to several authorities we could address, sometimes even with personal contact information. Lastly, the admission procedure for unconventional, innovative drugs such as BaKillus also faces ethical concerns, just as the synthetic biology field in general. Since Prof. Hasford has been a member of several ethics commissions we had the privilege to get an in-depth look at the work of an ethics commission, which looks for the right balance between the risks and the benefits for the patients and the general public.

Dr. Ulrich Ehlers

Federal Office of Consumer Protection and Food Safety

Main Concerns

• How is the release and Marketing of a GMO regulated?

What we learned"

• The current regulations for placing a GMO on the market were primarily designed for plants

BaKillus would not only need to fullfil the criteria according to the laws regulating the approval of drugs, but on the same time is a genetically modified organism (GMO). The release outside of the lab would need a permission of by the Federal Office of Consumer Protection and Food Safety. To address these questions and learn about the legal directives regulating the release of a GMO we contacted Dr. Ulrich Ehlers. Unfortunately, the legal situation for the market placement of GMO other than plants is insufficient. The current regulations were designed based on the emergence of genetically modified crops. Nevertheless, marketing of BaKillus would still be possible by applying for a drug approval at the Paul-Ehrlich-Institute (PEI, Germany) or the Center for Advanced Therapies (CAT) at the European Agency (EMA). Together with the application

Healthcare sector

Medizin Innovativ - MedTech Pharma 2014

Congress and Exhibition

Main concerns:

• Learn about new developments of the health sector and network with its experts.

What we learned:

• We gained an in depth-look into innovations of the broad medical field and their corresponding affairs and had a great opportunity to connect with participants and exhibitors from various disciplines.

To learn about recent developments in the healthcare sector and network with experts, we participated at the two-day congress Medizin Innovativ taking place at the Nuremberg Convention Center in July. This congress with nearly 1000 participants has become one of the most important meeting points for the medical sector in Germany in recent years. Combining a series of lectures on scientific, technical and operational market-related topics with a large exhibition comprising 120 exhibitors, the congress provides ideal conditions to connect participants from various disciplines. The variety of participants from company representatives to scientists and clinical users has always been a unique feature of this event. On the first day, we attended the lecture session about Regulatory Affairs: Pharma & Diagnostics which informed us about the new European regulations on clinical trials. In this session, we also learned about risk management of medical products. Later on, we heard about innovative Smart Medical Systems. During the breaks, we introduced our project idea to several exhibitors, such as representatives of pharmaceutical companies or patent lawyers, in order to receive feedback, first estimations about its feasibility and problems we might face. The next day, we continued our tour through the exhibition and talked to regulatory authorities and companies focusing on the design and accomplishment of clinical trails. Moreover, we had a look at the poster session, where scientists from universities and research institutions presented their latest results. In the afternoon, we participated in the lecture session about Market Access Strategies, where we heard about different financing strategies and about price regulations on the European market. All in all, the congress was a great opportunity to get introduced into all facets of the healthcare sector. We had an awesome chance to network with experts and are very thankful for their kind cooperation and their feedback, which gave us a lot input for our further considerations on our project’s potential and its implementation strategy.

Find more impressions and information:

http://www.medtech-pharma.de/english/congress/congress.aspx

LMU Summer School Workshop - How do innovative products enter the German health care system?

David Reinhardt, PhD candidate in Public Health, led the seminar

Gerd Dievenich (center), M.R.D.A., accompanied us to the beer garden

Main concern:

• Workshop about Registration Processes for Medical Products

What we learned:

• The legal situation in the EU and Germany is insufficient for the medical application of microbials
• Although BaKillus is a drug as well as a medical device, the market authorisation would have to be granted for it specifically as a drug

Experts:

• Led by David Reinhardt, PhD candidate in Public Health
• Gerd Dievenich, Master of Drug Regulatory Affairs (M.D.R.A.), Assistant Director Regulatory Affairs MSD SHARP & DOHME GMBH
• Dr. Franziska Baumgarten, Astracon GmbH

A medical application with a microbe as its active component would not only be a novum to the health care system, but also raise a lot of questions concerning legal issues. We had the great opportunity to join a workshop about how innovative medical products enter the health care system, organized by the LMU MeCuM mentorship program and dealing with questions that would also affect our application. The workshop was led by David Reinhardt, currently finishing his PhD in Public Health, and took place on four afternoons over two weeks. The basic aim of the workshop was to convey the basic principles of the R&D process, respective laws and governmental institutions dealing with new drugs and medical devices entering the market. The participants were highly international and interdisclipanary (physicists, public health researchers and biologists) with motivations ranging from a possible future career in the pharmaceutical sector to general social interests with health being a public good. Also experts were invited to give presentations about the regulatory affairs concerning new drugs and medical devices.

As part of the workshop we had the opportunity to present and discuss our project BaKillus. It not only drew attention due to its innovative therapeutical approach, but also highlighted the incomplete legal regulation of microbial GMOs as therapeutical applications in the EU and Germany and served as an interesting case study for further discussions. We learned that the regulations for the marketing of drugs and devices are entirely different and our nasal spray might be affected by both regulatory categories. However, market authorisation would be granted under the regulations of drugs, being the more restrictive one with the need for clinical trials. Lastly, during the workshop we dealt with laws and underlying legislation processes, which really helped us to understand the complex process of a medical product, from design to marketing.

Intellectual Property

Patent attorneys Dr. Andreas Koch & Dr. Gerhard Weinzierl

European Patent attorneys and Co-Founders of “Schiweck, Weinzierl, Koch - European Patent Attorneys”
Assistant lecturers in the area of “IP and patent laws” for the Department of Genetics, Faculty of Biology, LMU

Main concerns:

• Information on the Research and Development process of new medical products
• Principles of patents and their roles for funding

What we learned:

• Patents protect your innovation
• Patents are indispensable for the funding of the R&D process of medical products
• Optimization and development of a gene for an application is easier to protect than just the characterization and discovery of a native function

To get an insight into the principles of marketing a new medical product we met with Dr. Andreas Koch and Dr. Gerhard Weinzierl, two european patent attorneys. It is standard practice that the R&D process of a new promising product or compound always starts with a patent application. However, our intention for BaKilllus was to create a cheap medication available to everyone. In the discussion, Dr. Andreas Koch and Dr. Gerhard Weinzierl pointed out that patents should not only be regarded as a tool favouring big companies and hindering progress by prohibiting the use by other researchers, but also as a mechanism to protect your innovation. This is specifically important for BaKillus as a medical product: the patent serves as a guarantee for potential investors and ensures the funding of the high costs associated with the approval of a new medical product. For us that would mean that even if there were already patents on some of our modules (e.g. the agr-sequence), a patent would still be possible if its design and context of application are novel. Also, due to their experience we were provided with insights into the biomedical industry and had the chance to discuss the rise of start-ups, e.g. [http://www.glycotope.com/ Glycotope]. The discussion helped us shed light on the marketing process and showed us that patents are not bad per se, but are a useful tool depending on the intended use of the owner. Moreover, tools like the BioBrick™ Public Agreement (BPA) show that patents and open source are not a contradiction.