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The project is grounded in a striking observation: Ukraine was the dominant location of pharmaceutical production in the USSR, accounting for over 70% of the total Soviet pharmaceutical R&D and production capacity. Today, these capabilities remain still “in the ground and air”. Economists refer to this legacy as the country’s “industrial memory”. These unique capabilities hold significant relevance for discussions on industrial policy and highlight Ukraine’s potential to reclaim its position as a major player in the global pharmaceutical industry.

Rebuilding Ukraine’s pharmaceutical sector is a strategic win-win project. An EU-integrated Ukrainian pharma sector could strengthen Continental supply chain resilience. The COVID-19 pandemic and geopolitical tensions exposed Europe’s overreliance on Asian producers for medicine. Having a modern Ukrainian pharmaceutical base next to the EU would diversify supply sources and act as a buffer in times of crisis.

The project proposes developing a comprehensive playbook to support the rebirth of Ukraine’s pharma industry. This playbook will help fill gaps in the EU’s supply networks and create a high-value added component for Ukraine’s economy by contributing to the country’s economic growth and resilience.

Members of the project team working at the Max Planck Institute for Innovation and Competition are:

Prof. Dietmar Harhoff, Ph.D. (Director at the Institute), Prof. Dr. Nataliia Mazaraki (Head of the Academic Department of International, Civil, and Commercial Law at the State University of Trade and Economics, Ukraine) and Prof. Dr. Liudmyla Petrenko (Business Economics and Entrepreneurship Department at Kyiv National Economic University named after Vadym Hetman) as well as Senior Research Fellows Michael E. Rose, Ph.D., and Dr. Daria Kim.

The local team will collaborate closely with Ukrainian researchers and institutions, which will play a key role in shaping the project’s research agenda and ensuring its relevance to the Ukrainian context:

Oksana Kashyntseva, Ph.D. (Advisor to the Head of the National IP Office of Ukraine), Yevgeniya Piddubna (Director of Corporate Communications at Farmak JSC), Olha Urazovska, Ph.D. (Deputy Head of the Intellectual Property and Innovations Department of the National IP Office of Ukraine), Olha Omelchenko, Ph.D. (Senior Researcher at the Scientific-Research Institute of Intellectual Property of the National Academy of Law Sciences), Anastasia Homeniuk (Ph.D. Student and Junior Researcher at the Scientific-Research Institute of Intellectual Property of the National Academy of Law Sciences), Tetiana Pyatchanina, Ph.D. (Head of the Department of Patent and Licensing Activities and Information Support at the R.E. Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology of National Academy of Sciences), Yaroslav Iolkin, Ph.D. (Senior Researcher at the Scientific-Research Institute of Intellectual Property of the National Academy of Law Sciences), and Viktoriia Kyrylenko (Ph.D. Student, Kyiv National Economic University named after Vadym Hetman).

Through this collaboration, we will foster a deeper understanding of the country’s industrial capabilities and identify opportunities for growth and development.

We are grateful for the VolkswagenStiftung’s support, which once again recognizes the value of unorthodox research and its potential to drive positive change. The funding will enable the Institute to pursue the ambitious goals and meaningfully contribute to the revitalization of Ukraine’s pharmaceutical industry.

For more information on the project, please refer to the project poster (PDF).

The Block Exemption Regulation for Technology Transfer (TTBER) states that Article 101(1) TFEU does not apply to certain categories of technology transfer agreements. Since November 2022, the EU Commission has been conducting a review process, which has now entered the impact assessment phase. In its statement, the Institute focuses in particular on the questions raised by the European Commission in its call for contributions of 31 January 2025.

In view of the technological developments since the adoption of the current Block Exemption Regulation, the statement examines, among other things, whether and how the licensing of artificial intelligence (AI) data and models should be covered. With regard to data, it recommends a cautious approach to extending the scope of the TTBER to certain categories of data and data-related rights. While the Institute believes that data licensing in the European Union should be improved to promote innovation and social welfare, particularly in the context of AI development, it also argues that the TTBER is not the appropriate framework for this. Instead, consideration should be given to separate guidelines that go beyond data licensing and promote data sharing through rules on Article 102 TFEU.

With regard to the licensing of AI models, the statement emphasizes that the Commission should clarify the scope of application in the TTBER and in the guidelines, both in relation to the current applicability of the TTBER to certain cases and in relation to the inclusion of AI models.

The statement supports the Commission's view that applying market share thresholds to technology markets raises practical difficulties. Nevertheless, the Institute advises against changing the rules in the TTBER. Instead, the Institute would support a transition from a “4plus” to a “3plus” rule in the TT Guidelines.

The Commission's intention to incorporate case law on pay-for-delay settlements into the TT Guidelines is supported by the statement. Specifically, the opinion recommends the formulation of a specific hardcore restriction that explicitly reflects the conditions for classifying the licensing of rights as part of pay-for-delay settlements as a restriction by object within the meaning of Article 101(1) TFEU.

The safe harbour criteria for technology pools set out in the TT Guidelines are in principle supported by the statement as being appropriate. Finally, the Institute recommends that the Commission include specific rules in the TT Guidelines — including a safe harbour rule — for the assessment of agreements on licensing negotiation groups (LNGs) concluded between potential licensees under Article 101 TFEU.

Position Statement as PDF:

Position Statement of the Max Planck Institute for Innovation and Competition of 25 April 2025 in the framework of the revision of the Technology Transfer Block Exemption Regulation and the accompanying Guidelines

Carbon markets play a critical role in firms’ and governments’ climate strategies by enabling the purchase and sale of carbon credits. These credits represent a specific amount of carbon emissions (CO₂) that has been mitigated through projects, such as avoiding deforestation or destroying potent greenhouse gases. These credits help organizations and countries meet their climate targets by offsetting a portion of their own emissions.

The Problem

A pressing question is whether these carbon credits really reflect genuine emission reductions or whether the claimed effects are illusory. Do these projects truly benefit the environment or are we paying for something that lacks tangible value? Carbon crediting mechanisms allow project developers to earn credits through emission reduction projects. However, numerous studies have raised concerns about environmental integrity. A systematic assessment has been lacking to date.

The New Study and its Findings

The new meta-study published in Nature Communications analyzes 14 studies covering 2,346 climate projects and 51 studies of comparable projects for which no carbon credits were issued. All studies considered were based on experimental or rigorous observational methods. The analysis covers one fifth of the total credit volume issued to date, which corresponds to almost a billion tonnes of CO₂ emissions.

The analysis shows that less than 16% of carbon credits issued to the evaluated projects represented actual emission reductions. Specific examples of this are:
 

• For clean cookstove projects, in which traditional stoves are replaced by cleaner ones, the actual emission reductions corresponded to only 11% of the carbon credits issued.
• In the abatement of the potent greenhouse gas SF₆, the actual emission reductions amounted to only 16% of the carbon credits issued.
• Avoided deforestation showed a 25% reduction.
• Reducing the potent greenhouse gas HFC-23 performed comparatively well, with actual emission reductions amounting to 68%.

With regard to wind energy, the data shows that the projects would probably have been implemented even without the sale of carbon credits and that issuing carbon credits did not lead to any additional mitigation. Improved forest management was also implemented in reference areas without access to carbon credits to the same extent as in areas that benefited from carbon credits.

In projects destroying the waste gases hydrofluorocarbon (HFC)-23 and sulphur hexafluoride (SF₆) in industry, however, the data shows that waste gas generation increased when plant operators were able to generate carbon credits.

Urgent Need for Improved Certification Rules

Dr. Benedict Probst, Head of the Net Zero Lab at the Max Planck Institute for Innovation and Competition, emphasized, “There is an urgent need to establish better rules for issuing carbon credits. All project types face systemic quality issues, and the quantification of emission reductions needs substantial improvement.”

Co-author Dr. Lambert Schneider from the Oeko-Institut in Berlin points out that there is too much leeway when calculating emission reductions. “The rules of the carbon crediting programs often give project developers too much flexibility. This can lead to unrealistic assumptions being made or inaccurate data being used, resulting in an overestimation of reductions.”

The carbon crediting programs have a particular responsibility to improve the quality of the carbon credits, the authors indicate. Carbon crediting programs should enhance their approaches to assessing projects and calculating emission reductions to ensure they are based on conservative assumptions and the latest scientific findings.

The Societal Importance of the Study

Major climate goals are at risk: if carbon credits do not lead to real emission reductions, we will not make the progress we think we are making in combating climate change.

A potential trust issue looms: governments and firms rely on carbon credits to meet their climate pledges. If these credits are ineffective, it could undermine trust in carbon markets, which are seen as an essential tool in the fight against global warming.

Avoiding potential greenwashing is critical: some firms could use ineffective carbon credits to claim “carbon neutrality” without actually reducing their emissions, misleading consumers and regulators.

Conclusion

The study shows that carbon markets are not delivering the necessary and expected impact. Reforms are urgently needed to ensure that carbon credit mechanisms are truly contributing to mitigate climate change. If we do not reform these mechanisms, we risk missing climate targets and allowing firms to appear more environmentally friendly than they really are.

About the Net Zero Lab

Environmental economist Benedict Probst has led an independent Max Planck Research Group at the Max Planck Institute for Innovation and Competition in Munich since May 2024. The Net Zero Lab aims to accelerate the development of green technologies that are crucial for replacing fossil fuels in industry as well as of technologies that directly remove CO₂ from the atmosphere.

For more information on the Net Zero Lab, see: https://www.netzerolab.science/

Directly to the study:

Probst, Benedict S., et al. (2024). Systematic assessment of the achieved emission reductions of carbon crediting projects, Nature Communications, 15, 9562. Available at https://doi.org/10.1038/s41467-024-53645-z

All data in filterable graphics: https://www.carboncredits.fyi/

Other scientists and institutions contributing to the study:

Malte Toetzke (1,4), Andreas Kontoleon (3), Laura Díaz Anadón (3,5), Jan C. Minx (6,7), Barbara K. Haya (8), Philipp A. Trotter (10,11), Thales A.P. West (3,12), Annelise Gill-Wiehl (13), Volker H. Hoffmann (2)

(1) Net Zero Lab, Max Planck Institute for Innovation and Competition, (2) Group for Sustainability and Technology, ETH Zurich, (3) Department of Land Economy, Centre for Environment, Energy, and Natural Resource Governance, University of Cambridge, (4) Public Policy for the Green Transition, Technical University of Munich, (5) Harvard Kennedy School, Harvard University, (6) Mercator Research Institute on Global Commons and Climate Change, (7) Priestley International Centre for Climate, School of Earth and Environment, (8) Goldman School of Public Policy, University of California, Berkeley, (9) Oeko-Institut, Berlin, (10) Schumpeter School of Business and Economics, University of Wuppertal, (11) Smith School of Enterprise and the Environment, University of Oxford, (12) Institute for Environmental Studies (IVM), Vrije Universiteit Amsterdam, (13) Energy & Resources Group, University of California, Berkeley.

The Institute is officially recognized by UNCITRAL due to its research focus in the field of Artificial Intelligence (AI) and Data Law respectively. The technology-specific research approach, which the Institute pursues more closely, especially in invention and creation processes in the IP area, helped in the preliminary work and in the final version, which was adopted by the UNCITRAL Commission this summer at its 57^th session in New York.

The Model Law provides a legal framework to enable the use of automation in contracts, including the use of AI technologies and “Smart Contracts”, as well as for machine-to-machine transactions. It is intended to complement and supplement existing laws on electronic contracting, particularly those based on other UNCITRAL texts on electronic commerce. These have already been adopted in over a hundred jurisdictions worldwide. The Model Law is the first piece of legislation to emerge from UNCITRAL's exploratory work on legal issues relating to the digital economy and digital commerce. One of its primary objective is to reduce legal uncertainties and transaction costs, thus promoting AI-driven innovation. Meanwhile, work continues on related areas, such as data contracts and distributed ledger technology (blockchain).

About UNCITRAL
The United Nations Commission on International Trade Law (UNCITRAL) is the core legal body of the United Nations system in the field of international trade law. Its mandate is to remove legal barriers to international trade through the progressive modernization and harmonization of trade law. It prepares legal texts in a number of key areas such as international commercial dispute settlement, electronic commerce, insolvency, international payments, sale of goods, transport law, procurement and infrastructure development. 
 

Press release of UNCITRAL
Documents of the UNCITRAL Working Group Electronic Commerce

The OA movement seeks to eliminate cost barriers for accessing scientific knowledge. This is supported by major international policies like the Berlin Declaration (2003) and mandates such as the U.S. White House Directive (2022). By 2025, federally funded U.S. research must be freely available without delay, underscoring OA’s expanding global influence.

Impact on Researchers and Institutions

For researchers, publishing in reputable, high-impact journals is essential for career advancement. Historically, the costs of accessing research were managed by university libraries, resulting in steep subscription price increases, known as the “serials crisis”. OA, through models like “Gold OA” (funded by article processing charges – APCs) and transformative agreements (TAs), has sought to address these challenges by shifting costs to publishing rather than reading.

Yet, debates persist. Critics worry that APC-based systems might compromise research quality by incentivizing volume over rigor. Additionally, while OA enhances visibility and downloads, its impact on citation metrics remains modest. Meanwhile, transformative agreements between publishers and institutions aim to cap costs but show varying success in fostering competition and transparency.

Comprehensive Analysis of Open Access Impacts

The authors examine how OA policies, particularly TAs, are reshaping the relationships between researchers, publishers, and institutions. They highlight that while OA increases the visibility of research, it also introduces challenges, such as the potential impact of  APC-based models on research quality.

Evaluation of Transformative Agreements (TAs)

A major focus is on TAs, which aim to replace subscription costs with OA publishing fees. The authors analyze these agreements for their effectiveness and incentive structures, pointing out that many TAs (with notable exceptions like those at the University of California) lack sufficient mechanisms to control costs effectively.

Emphasis on Market Structures and Competition

The article highlights the opportunities and risks OA poses for competition among publishers. While APC-based OA theoretically enhances competition for paper submission among publishers by shifting the decision-making from readers under the traditional reader-pays model (multi-homing) to authors under the author-pays model (single-homing), the authors warn that OA “Big Deals” (where one or more universities and a single publisher negotiate the APCs for publishing in any of the latter’s journals) may further concentrate the market and stifle innovation.

Linking Publishing and Data Analytics

The authors explore how major publishers like Elsevier are increasingly integrating data analytics tools into their business models, potentially enhancing their market dominance. This trend is critically evaluated for its implications on competition and the independence of scientific data analytics.

Policy Recommendations and Evidence-Based Experiments

Mueller-Langer and McCabe advocate for experimental approaches to accompany policy measures like the U.S. Office of Science and Technology Policy (OSTP) initiative. These could help better understand the effects of new funding and publishing models, allowing for more informed and effective policymaking.

Conclusion

The authors provide valuable insights into how OA strategies could reshape the balance between publication costs, access to research, and quality assurance. Their article emphasizes the need for careful monitoring and evaluation of market mechanisms to ensure a sustainable and competitive scholarly communication landscape in the long term.

Directly to the study:

McCabe, Mark J.; Mueller-Langer, Frank (2024). Open Access Is Shaping Scientific Communication – Funders and Publishers Should Roll Out Policies in Ways to Support Their Evaluation, Science, 385 (6714), 1170-1172. Available at https://doi.org/10.1126/science.adp8882

The new study examines whether pharmaceutical firms move away from filing strategic patents once the focal drug gains marketing authorization and the disclosed trial-related information becomes novelty-threatening prior art.

The authors construct novel patent-drug dyadic data and leverage unique European drug patent and marketing contexts. Using an event study methodology, they exploit plausibly exogenous variation in the length of time from patent filing to drug approval. First, they illustrate that drugs with early and late marketing authorization share similar ex ante patent and drug characteristics. Second, they support the hypothesis that strategic patenting behavior decreases substantially after marketing authorization. In contrast, meaningful follow-on innovations remain unaffected. Third, they show that these effects are likely driven by obstacles in the enforceability of marginal patents filed after approval.

The results of the study suggest that post-marketing increases in patentability standards are welfare-enhancing with examiner scrutiny and firm self-adjustment. They highlight the importance of better data provision to patent examiners to increase the quality of follow-up inventions.

Lucy Xiaolu Wang was a Senior Research Fellow at the Institute and is now a tenure-track Assistant Professor at the University of Massachusetts Amherst. She continues to be closely associated with the Institute as an Affiliated Research Fellow.

Dennis Byrski was a Junior Research Fellow at the Institute. In 2021 he submitted his doctoral thesis titled “From Scientific Research to Healthcare Markets – Empirical Essays on the Economics of Pharmaceutical Innovation”. He is now a Junior Engagement Manager at McKinsey & Company.

The American Society of Health Economists is a professional organization dedicated to promoting excellence in health economics research. It aims to enhance individual and societal health by providing evidence and expertise for the development of private and public policies. ASHEcon’s awards honor individuals who have made significant contributions to the field of health economics.

Directly to the publication:
Byrski, Dennis; Wang, Lucy Xiaolu (2024). Marktzulassung und strategische Patentierung: Evidence from Pharmaceuticals. Verfügbar unter https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4638115.

More information:
2024 ASHEcon Award Winners

With its findings, the international project Data Governance in Emerging Economies to Achieve the Sustainable Development Goals contributes to the discussion on how Data Governance can be used to achieve the Sustainable Development Goals of the United Nations, especially in emerging economies. Together with researchers from India, the data governance landscape in the Indian healthcare sector is being examined. The report, which has now been published, presents preliminary findings along with questions for defining a research agenda building on the insights from the multistakeholder-workshops organized in Bengaluru in September 2022.

Written in the specific context of SDG 3, the report underscores the role of data governance for good health and well-being in India. A brief introduction to the project is followed by four more sections. It first provides a detailed background on the selection of SDG 3 and India for the study of data governance in growth regions. The second section offers an overview of the existing legal framework for data governance in India. In addition to analyzing open data initiatives, this section maps the judicial and legislative steps towards safeguarding personal data, while highlighting the ongoing efforts to legislate non-personal data sharing. In addition to analyzing open data initiatives, this section outlines the legal and legislative steps taken to protect personal data and highlights the ongoing efforts to legislate the sharing of non-personal data. The findings from the workshop are used in the next section to examine the role of the public sector, private sector and start-ups in determining the scope of data governance in the Indian healthcare sector. The final section summarizes the findings and emphasizes the importance of a data governance framework for achieving the Sustainable Development Goals, particularly SDG 3 in India. Finally, the researchers pose a series of questions aimed at developing a research agenda to help build a framework for data governance in emerging economies like India.

A result of doctrinal research and participatory discussion with the stakeholders, the report indicates the need for stronger engagement with all the stakeholders for evolving appropriate data governance frameworks – including but not limited to – measures establishing legal rights and obligations of stakeholders. The institutional and technical aspects of data governance are considered an essential complement. More broadly, project deliberations point towards significant gains resulting from a data governance approach, developed in close relation with the SDG framework, to legal research and policy formulation.

Arul George Scaria, Vikas Kathuria, Shraddha Kulhari, Vidya Subramanian
Data Governance in Emerging Economies to Achieve the Sustainable Development Goals
India Country Report Based on the Workshop Data Governance for Good Health & Well-Being: India’s Way Forward to Achieving Sustainable Development Goal 3 (Bengaluru, September 8-9, 2022)
Max Planck Institute for Innovation & Competition Research Paper No. 24-08

Mor Bakhoum, Begoña Gonzalez Otero, Jörg Hoffmann, Minata Sarr
Data Governance in Emerging Economies to Achieve the Sustainable Development Goals
Senegal Country Report Based on the Workshop Shaping Data Sharing Policies in the Agricultural and the Financial Services Sector (Dakar, March 16-17, 2022)
Max Planck Institute for Innovation & Competition Research Paper No. 24-05

It was based on the results of a workshop that took place in Dakar (Senegal) in March 2022. This was part of the broader international project "Data Governance in Emerging Economies to Achieve the Sustainable Development Goals (SDGs)", which examines the opportunities and possibilities offered by data policy to achieve the United Nations' Sustainable Development Goals.

Structured into four distinct parts, the report provides an exhaustive evaluation of Senegal's regulatory landscape concerning data access and sharing (Part I), laying the groundwork for a detailed examination of the alignment of these regulations with SDGs. It then focuses on the agricultural sector's data-sharing practices and their potential contributions to economic growth and sustainable development (Part II), followed by an exploration of the challenges and opportunities in data governance for financial services in the digital era (Part III). Part IV synthesizes the workshop's discussions, offering valuable insights, conclusions, and forward-looking recommendations.

This scholarly endeavor contributes significantly to the ongoing discourse surrounding data governance and its pivotal role in realizing the SDGs. The nuanced analysis and insights presented herein serve as a valuable resource for policymakers, academics, and practitioners operating at the intersection of data governance, development, and sustainability. Moreover, the outlined recommendations and prospective research agenda provide a roadmap for our future endeavors aimed at advancing data governance in emerging economies, aligning with the vision of the UN AI Advisory Board to govern AI for humanity.

Mor Bakhoum, Begoña Gonzalez Otero, Jörg Hoffmann, Minata Sarr
Data Governance in Emerging Economies to Achieve the Sustainable Development Goals Senegal Country Report Based on the Workshop Shaping Data Sharing Policies in the Agricultural and the Financial Services Sector (Dakar, March 16-17, 2022)
Max Planck Institute for Innovation & Competition Research Paper No. 24-05

On 27 April 2023, the European Commission presented its proposal. The proposed regulation aims at improving the licensing of SEPs by reducing the uncertainty that surrounds licensing negotiations and lowering transaction costs. In order to achieve these objectives, the Commission has considered different policy options. Of these, the Proposal implements (1) the setting up of a mandatory register for SEPs with essentiality checks of selected and representative random samples of SEPs, (2) the establishment of a process for determining a non-binding aggregate royalty rate, and (3) a mandatory pre-litigation conciliation procedure for FRAND royalty determination, combined with (4) voluntary guidance on SEP licensing. Institutionally, a new competence centre within the European Intellectual Property Office (EUIPO) is to be in charge of managing and performing these tasks.