Institute News

The roundtable was organized by Liudmyla Petrenko, Daria Kim, and Oksana Kashyntseva, and focused on health-related policies and regulations in Ukraine.

The speakers represented a wide range of institutions, including the National Security and Defense Council of Ukraine, the Kyiv National Economic University, the Ukrainian Association for Clinical Research, the Taras Shevchenko National University of Kyiv, the National Academy of Legal Sciences of Ukraine, and the Yaroslav Mudryi National Law University.

The Ukrainian Pharmaceutical Industry: Strategic and Industrial Policy Perspectives

In the first panel, moderated by Dietmar Harhoff, the discussion focused on the high rate of pre-war development of the industry, its potential, and the devastation of the first year of the war.

Ukrainian pharma has over 100 years of history. The first industrial pharmaceutical production was established in Kharkiv in 1907. During Soviet times, approximately 70 % of the industrial pharmaceutical and research capacity of the Soviet Union was concentrated in Ukraine. In the year before the war, Ukraine’s pharmaceutical market totaled over 3.6 billion USD. The pharmacy segment accounted for 3.2 billion USD, while the hospital segment accounted for 0.4 billion USD.

As of today, 1,400 buildings in Ukraine have been damaged or destroyed, including 574 health care facilities. The majority are primary, emergency, and specialized care institutions. According to preliminary estimates, the cost of reconstruction is about 1 billion USD. Correspondingly, the Ukrainian pharmaceutical market losses in 2022 compared to 2021 amounted to 22.4 % in physical terms (units of drugs), 26.7 % in monetary terms, and 19.2 % in pharmacies, of which nearly 4,000 were closed. As a consequence, the access to medicine was disrupted all over Ukraine.

Drug Research and Development in Ukraine

The second panel, moderated by Anastasiia Lutsenko, focused on clinical trials.

Clinical research before the war had a significant economic impact. Every year, Ukraine’s share of patients in clinical trials was 2 % of the global patient pool (30,000 active participants in 500 studies), which is a great share for such a small country. In the five years before the start of the war, the number of new clinical studies increased by a factor of 2.5, the number research sites grew by 20 % and the number of active researchers in the field by 44 %.

The plan for restoring the Ukrainian health care system from the consequences of the war for the next decade provides for exemption from VAT on imports of medicines for clinical trials, tax, and other incentives for companies involved in conducting clinical trials, the development of the research infrastructure and research potential, and the introduction of an insurance system for clinical research in the form of compensation for possible damages to all participants in clinical trials.

A Regulatory Framework Outlook for the Ukrainian Pharmaceutical Sector

The presenters of the third panel, moderated by Daria Kim, criticized the practice of pharmaceutical marketing in Ukraine.

They accused the inadequate approach of pharmaceutical and medical professionals in performing their duties, for example, by promoting products that are either dangerous to patients or without proper therapeutic effect to receive an improper benefit. They also addressed the monopolization of pharmacy activity, which is carried out in covert form and results in significant price increases for pharmaceutical products, and the adulteration of pharmaceutical products.

The tacit support of monopolization of pharmacy activities by the state, especially by local governments, and the creation of pharmacy mega-chains has led to minimization of economic competition and abuse of monopoly power. The state’s tacit consent to the development of marketing agreements in the pharmaceutical market has increased the cost of medicines. Comparison with prices in reference countries has shown that, before the war, prices for pharmaceutical products in Ukraine were inflated by 40 % due to the use of marketing agreements.

Perspectives on Intellectual Property in the Pharmaceutical Industry in Ukraine

The last panel, moderated by Reto M. Hilty, showed that Ukraine has significant production capacities with about 120 pharmaceutical companies, which offers options for further cooperation between Ukraine and the European Union:

• Contract manufacturing for major international producers of medicines, transfer of new technologies and production of innovative pharmaceuticals (to supply the markets of the EU, Ukraine, Moldova, Georgia, and Middle East and North Africa)
• Integration of Ukraine into reduced supply chains through the production of active pharmaceutical ingredients (API) for the needs of the EU
• Production of mRNA-based vaccines in Ukraine
• Guarantee of uninterrupted supply of generic medicines (by replacing supplies from China and India)
• Conducting clinical trials in Ukraine to replace the Russian market, where trials are now suspended by most international companies due to international sanctions.

The roundtable ended with appeals to the EU and international partners to develop and implement programs to encourage international companies to cooperate on technology transfer and the localization of drug production in Ukraine, and to make use of the country’s logistical advantages. It was also suggested to create financial support programs for the development of API production in Ukraine. The regulatory barriers for the export of Ukrainian medicines to the EU should be simplified through the implementation of special inspection procedures to ensure good manufacturing practice (GMP) following EU GMP standards, and special inspection procedures for the domestic market of Ukraine (PIC/S GMP standards) as well. This should be accompanied by the establishment of training programs and the appropriate validation of inspectors issuing certificates according to EU GMP standards for Ukrainian producers.

We thank all speakers and participants, especially our guests from Ukraine, as well as the organizers for their valuable contributions, and look forward to further Roundtables to help rebuild Ukraine for a properous future.

See the full program with all speakers and their affiliations, and all topics.

To the short review of the first exploratory roundtable held on 1 December 2022.

The project implemented by Yuriy Kapitsa is dedicated to the modern development of intellectual property law in the European Union and the alignment of Ukrainian legislation with the EU acquis. The project envisages a complex study of current trends in the development of EU policy and intellectual property law in 2017 – 2022. Furthermore, within the project a comparative study of the EU and Ukrainian legislation and the definition of directions for the approximation of Ukrainian IP law to the current changes in the EU legislation.

The relevance of the project is related to the integration of Ukraine and the EU within the framework of the Association Agreement between the European Union and Ukraine of 2014 and Ukraine’s status as a candidate for EU membership, which implies the alignment of Ukrainian legislation with EU legislation. The research was characterized by a creative atmosphere, in which he discussed with Silke von Lewinski, Heiko Richter and other colleagues, issues of the development of EU legislation.

Currently, Yuriy Kapitsa continues his work at the Centre for Intellectual Property Studies and Technology Transfer of the National Academy of Sciences of Ukraine. He is actively working with the new Ukrainian Patent Office – the Ukrainian National Office for Intellectual Property and Innovations – on the approximation of Ukrainian and EU legislation in the field of intellectual property and other issues of European integration. The scope of his work also includes legal support for the creation and commercialization of intellectual property rights at the institutes of the Academy of Sciences. This concerns, in particular, the extension of the application of the current forms of technology transfer and R&D agreements at the institutes of the Academy.

About Yuriy Kapitsa:
Yuriy Kapitsa, Dr. of Legal Sciences (habil.), J.S.D., is the Director of the Centre for Intellectual Property Studies and Technology Transfer of the National Academy of Sciences of Ukraine and has been engaged in comparative studies of EU and Ukrainian intellectual property law and protection and commercialization of intellectual property in academic institutions for many years. He led the National project on approximation of Ukrainian legislation in the field of intellectual property to the EU legislation within the framework of the national program on approximation of Ukrainian legislation to that of the European Union. He has also participated as an expert in a number of EU projects on the approximation of third country legislation to the EU acquis. He is the author and co-author of the books European Union Intellectual Property Law: Formation, Institutes, Directions of Development, 2017, 2021; Copyright and Related Rights in Europe, 2012; Intellectual Property Law of the European Union and the Legislation of Ukraine, 2006; Inventive Activity in Academic Organizations, 2021; National Report Innovation Ukraine 2020 etc., as well as a number of academic articles (ResearchGate), co-author of the Civil Code of Ukraine (Chapter 4 “Intellectual Property Law”), the Laws on Science and Technical Activities, on Innovation Activity and many others. Dr. Kapitsa is a member of the Working Group on Recodification (Updating) of the Civil Legislation of Ukraine established by the Cabinet of Ministers of Ukraine and the Working Group on Intellectual Property Law of the European Federation of National Academies of Sciences (ALLEA).

Using AI in sectors such as agriculture, energy and transportation can lead to economic benefits while reducing greenhouse gas emissions. How can this technology be leveraged to create tangible impact and pursue a transformation that creates opportunities for all? How to develop ethical and trustworthy AI systems without a large carbon footprint? The CDTM Trend Report looks into these questions and provides an understanding of the potential of AI for tackling climate change in the next 20 years. It describes trends (political and legal, economic, social and environmental, technological, as well as business models) that explain the current and upcoming challenges of climate change, identifies potential future scenarios, and innovates new business models, ensuring a balance between sustainability, technology, and future prosperity.

The report was developed within the framework of the trend seminar at the CDTM, where 25 young innovative students from interdisciplinary backgrounds conduct holistic trend research over seven weeks on a specific, future-oriented topic. In the basic phase, a comprehensive trend analysis is prepared, the scenario phase is used to develop four future scenarios, and in the ideation phase, five future-proof digital business models are elaborated. In their work, the students were supervised, among others, by Anna-Sophie Liebender-Luc, who is now a Junior Research Fellow and Doctoral Student at the Institute.

Dietmar Harhoff presented the Trend Report to Judith Gerlach, Bavarian Minister of State for Digital Affairs, at AI.BAY2023, the 1st International AI Conference of the Bavarian AI Network baiosphere, held at the Deutsches Museum in Munich on 23 February 2023.

Directly to the CDTM Trend Report “Tackling Climate Change in the AI Era”.

At its meeting on 23 June 2022 in Berlin, the Max Planck Society’s Senate appointed Patrick Cramer as new President-elect of the Max Planck Society for the term of office from 2023 to 2029. The 54-year-old chemist and molecular biologist currently is Director of the Max Planck Institute for Multidisciplinary Sciences in Göttingen. He will take over the role from Martin Stratmann in June 2023 in Göttingen, where the MPG was founded, on the occasion of the 75^th anniversary of the Max Planck Society. Stratmann was at the helm of the Max Planck Society for nine years.

By the time he takes office as president of the Max Planck Society in June, Patrick Cramer wants to have visited all 86 Max Planck Institutes. A lofty goal that is within reach: Since July 2022, Cramer has visited nearly two-thirds of the Institutes. Our Institute was number 54 on his list. He was accompanied by Dr. Katja Ketterle, Head of the Institutes Department of the Max Planck Society, and Dr. Sabine Gieszinger, Institute Support.

Thus, on the morning of 24 January, after a joint photo session, the entire Institute gathered for a brief address by the President-elect, followed by a question and answer session.

Cramer spoke of a triad of core values of the Max Planck Society. First, he mentioned excellence, although pure scientific excellence would not suffice. It is also about the personalities and people around whom the Institutes of the Max Planck Society are built. The so-called Harnack principle is an essential part of the Max Planck Society’s strategy and crucial for attracting other outstanding minds. It is equally important to communicate and explain the work of top researchers to the public. Finally, the third core value he cited was the sense of unity among all employees of the Max Planck Society.

“We all are Max Planck,” Cramer emphasized in an open exchange with the Institute’s employees. It is the task of all employees to contribute to the goals of the Max Planck Society. It is equally important that the ideas of all members of the “Max Planck Family” are heard. The President-elect showed that he was open to the wishes, questions and suggestions of everyone.

He also answered personal questions. Just three years ago, he said, he could not have imagined that he might put his own research on hold in favor of his new responsibilities. Cramer has been director of the Göttingen Institute since 2014; before that, he was professor of biochemistry at LMU Munich and director of the Munich Gene Centre.

Cramer has made significant contributions to the development of life sciences, both through his own research and by mentoring and promoting young scientists. He solved the three-dimensional structure of one of the largest enzymes in the nucleus, RNA polymerase. This work enabled his team to unravel the mechanisms of gene transcription. Gene transcription is the process by which living cells make copies of their genes, which then serve as blueprints for the production of proteins. Shortly after the outbreak of the Covid-19 pandemic, Cramer and his group visualized how the coronavirus copies its genetic material. The team also showed how the Covid-19 drugs Remdesivir and Molnupiravir interfere with this copying process.

But now, Cramer said, he embraces the challenge of the new office and is convinced that it is important to help shape the future of science and bring new knowledge into the world for the benefit of all people.

In the further course of the visit, a group discussion was held with representatives of the researchers, IT, science communication and equal opportunity officers, in addition to discussions with the directors. Finally, a poster presentation of the Institute’s research highlights took place in a smaller circle.

Cramer was impressed by the social relevance of the research conducted at the Institute, highlighting in particular research on the transition to a sustainable economy, support for emerging economies, or on AI and the protection of private data. Katja Ketterle, head of the Institutes Department, emphasized how inspiring the brief insights into the research were and that the Institute also had a great team in other areas, making it one of the particularly fine small Institutes within the large Max Planck Society.

We thank you for your visit and look forward to further exchange!

Prof. Dr. Celso Fernandes Campilongo, Director of FDUSP, emphasized at the signing ceremony that partnerships such as this are fundamental for the advancement of FDUSP's faculty and students. This cooperation will develop projects that will serve to better use the creative and technological potential of Latin America to best meet the social, cultural, and economic needs and interests of this region of the world. Joint publications and events complement the research cooperation portfolio.

The first events are already in preparation: On 26 April 2023, the SIPLA Annual Conference will take place in São Paulo. The main topics will be technology transfer and regional innovation. The conference will be rounded off by four internal workshops devoted to the further development of SIPLA projects already underway in the areas of copyright, patent law, competition law, and trade secrets protection.

We plan to hold the Munich Summer Institute 2023 as an in-person event (no hybrid meeting) in Munich. The Munich Summer Institute will be preceded by the second MSI Ph.D. Workshop on 23 May 2023.

The Summer Institute will focus on three areas:

• Digitalization, Strategy and Organization
  (chairs: Tobias Kretschmer and Christian Peukert),
• Innovation and Entrepreneurship
  (chairs: Dietmar Harhoff, Joachim Henkel and Hanna Hottenrott), and
• Law & Economics of Intellectual Property, Innovation & Digitalization
  (chair: Stefan Bechtold and Imke Reimers).

The goal of the Munich Summer Institute is to stimulate a rigorous in-depth discussion of a select number of research papers and to strengthen the interdisciplinary international research community in these areas. Researchers in economics, law, management and related fields at all stages of their career (from Ph.D. students to full professors) may attend the Munich Summer Institute as presenters in a plenary or a poster session, as discussants, or as attendants. The Munich Summer Institute will feature three keynote lectures, 12 plenary presentations and a daily poster session (including a poster slam). The Munich Summer Institute focuses on quantitative empirical research.

The Munich Summer Institute will be held at the Bavarian Academy of Sciences and Humanities in the heart of Munich. Participation is by invitation only. The Munich Summer Institute will fund hotel expenses for all plenary speakers, poster presenters and invited discussants. It is expected that participants fund their own travel. The Munich Summer Institute may provide limited travel scholarships in case of financial hardship.

Keynote Speakers

• Nigel Melville, University of Michigan
• Jana Gallus, University of California at Los Angeles
• David Schwartz, Northwestern University

Paper submission procedure

Researchers who would like to present a paper are invited to submit their paper online until 15 February 2023 at http://editorialexpress.com/conference/msi2023. The Munich Summer Institute only considers papers which have not been published or accepted for publication at the date of submission. Paper selections will be announced in mid-March 2023. The program of the Munich Summer Institute will be available in early April 2023. All accepted papers will be made available to all participants on 14 May 2023. Researchers who would like to attend the Munich Summer Institute without giving a presentation should contact one of the organizers by 15 April 2023. 

Further information

More information is available at the MSI website. Any questions concerning the Munich Summer Institute should be directed to Stefan Bechtold, Dietmar Harhoff, Joachim Henkel, Hanna Hottenrott, Tobias Kretschmer, Christian Peukert, or Imke Reimers.

On 23 November 2021, the 193 Member States at UNESCO’s General Conference adopted the Recommendation on the Ethics of Artificial Intelligence, which is the first global normative in the field responding directly to the need for clear, ethically informed guidelines on the design, development and use of AI systems. This very first global standard-setting instrument on the subject is to not only protect but also promote human rights and human dignity, and will be an ethical guiding compass and a global normative bedrock allowing to build strong respect for the rule of law in the digital world.

The international conference on the UNESCO Recommendation was organized by the Romanian Ministry of Research, Innovation and Digitalization (MCID), together with UNESCO and two of the most prestigious Romanian Universities – West University of Timişoara (UVT) and Politehnica University of Bucharest (UPB) – and was held at the premises of Politehnica University of Bucharest in presence of Gabriela Ramos, Assistant Director-General for the Social and Human Sciences of UNESCO, and Sebastian-Ioan Burduja, Minister of Research, Innovation and Digitalization.

The event brought together a wide array of stakeholders from science, legal practice, policy, and civil society to discuss the UNESCO recommendation and its ability to serve as a global instrument for the ethical design, development and deployment of Al.

The conference centered around two main themes: the need to promote diversity and inclusiveness, and how to move from principles to practice to assess the ethical impact of AI on society.

Dietmar Harhoff was a keynote speaker and shared his professional vantage points to the first panel to discuss and explore issues such as the lack of diversity and inclusiveness in AI, algorithmic bias and discrimination, as well as possible measures to address these issues. However, he also pointed to the difficult trade-off between regulation and incentives for innovation.

Directly to the UNESCO Recommendation on the Ethics of Artificial Intelligence.

Data is at the heart of the ongoing digital transformation of the economy and society. In many different ways, access to data is becoming a precondition for innovating and for competing effectively. Against this background, both the European and the German legislator are striving to develop a legal framework for the data economy that facilitates voluntary agreements on data access and sharing and mandates data portability and/or data access where it is needed to protect – and sometimes to promote – competition.

The BMWK has asked the consortium consisting of lawyers and economists to determine whether the emerging legal framework is fit for the task of protecting and, where necessary, promoting competition, and to outline options for action in case of deficiencies. In fact, the inventory of the legal rules relating to data access and data sharing currently in place provides evidence of a great degree of legal uncertainty. Legal institutions, i.e. well-defined (intellectual) property rights, contract law principles and competition law principles, are only emerging. On the basis of this stocktaking exercise, the study discusses the need for reform and explores policy options. These relate to the European Commission’s proposal for a Data Act, European and German competition law including merger control, the Digital Markets Act and Section 19a GWB (German Act against Restraints of Competition), as well as the legal framework for data intermediaries.

The expert study is available at the following link:
Data access and sharing in Germany and in the EU: Towards a coherent legal framework for the emerging data economy