The regulation of agricultural biotechnology in Poland and the obstacles to EU compliance

Transition and accession have necessitated the establishment of a regulatory framework for agricultural crop biotechnology in Poland. This paper examines the theoretical and practical difficulties of complying with EU requirements. The first part of the study utilises evolutionary theory and path dependency to describe how policy makers interpret the requirements of accession through established conceptual models. Secondly the paper examines how accession programmes may alter path dependent trajectory but is simultaneously introducing or importing models which are fundamentally incompatible with national capabilities. Data presents the preaccession capacity building programmes and the import of German expertise as examples. The final section examines the issue of capacity and in particular, financial capacity, and uses this underlying theme to explore in detail why incompatibilities arise and why EU compliance is presented with certain obstacles

Emergence of the Biosimilar Sector and Opportunities of Developing Country Suppliers

As biologic products begin to come off-patent, a market is emerging for biosimilars (also known as biogenerics or follow-on biologics). Firms from emerging countries such as India and China have dominated the production of active ingredients in pharmaceutical industries all over the world and are now developing capabilities in biosimilar production. This emergence of a new market dynamic is disruptive to current key players as it has potential challenge their current dominant hold over the market, while for firms from developing countries it creates a sea of opportunities. This rise of biosimilars and capabilities for cheap production in developing country firms has potential to transform patient care in developing countries as well as advanced countries. This paper reviews study data collected at Innogen and the most recent literature to understand how the sector for biosimilars is evolving and the opportunities and challenges faced by emerging suppliers. The aim of the paper is to identify the gaps in the current literature and opportunities for further study in this area

Heterogeneity in learning processes and the evolution of dynamic managerial capabilities as a response of emergence of biosimilar market: evidence from the Indian pharmaceutical industry

This paper examines heterogeneity in the response of Indian firms to the emergence of a new segment in the pharmaceutical generics market – biosimilars. The necessary diversity of the knowledge base and regulatory requirements underlying biosmilar products have created significant technological capability and market access challenges for Indian firms. This is but the latest development which adds to an existing catalogue of challenges including the decline of the traditional generics markets, regulatory hurdles in advanced country markets and failures in managing new drug development. Using case studies of three Indian firms we show that dynamic managerial capability is a key driver of heterogeneity in learning processes involved in acquisition of technological capabilities for biosimilars and market access strategies. It further highlights the important role of pre-existing capabilities in enabling and constraining the development of new biosimilar capabilities

Innovative Capabilities of the Agricultural Biotechnology Sector in Hungary

This study investigates how context-specific institutional factors affect innovative capabilities of the agricultural crop biotechnology sector in Hungary. Answering this question has involved three areas of research, into: the network of actors and its accommodation of technological characteristics; the sustained use of institutional arrangements which characterised the pre-transition science and innovation system; and, the difficulty of adapting to the regulatory environment in the post accession phase. The significance of this work results from the lack of current knowledge on the extent and survival of capabilities in this sector in Hungary. The study timing is also significant: This is a phase that demonstrates how the sector is surviving the economic crisis that accompanied transition and enduring the current political uncertainty surrounding national GM crop policy. The study uses qualitative methods, comprising a series of in-depth investigations. Data collection via interview and observation began in 2006. Data collection and analysis were guided by a theoretical framework emanating from national innovation systems and triple-helix perspectives. This thesis explores the challenges that are faced by an innovation system during economic transition. The thesis also contributes to the knowledge of science systems and how core science capabilities have contributed to the endurance of a sectoral innovation system. In conclusion the work finds that innovative capabilities in the Hungarian agri-biotech sector currently reside in the core competencies and activities of the science community in this sector and the networks they have created over time within and outside the country. Their future survival depends on the ability of the sector to adapt to the changing context. The institutions between actors and organisations are key to survival of capabilities and their ability to adapt. Institutions hold both the adaptive mechanisms for change and the legacies of the past which can help or hinder that change

Global vaccine safety blueprint: the landscape analysis (survey of regulators)

The perspectives of regulatory licensing authorities were assessed in countries that produce, procure, and both produce and procure vaccines. A web-based survey was developed to explore regulators’ knowledge, attitudes and practices concerning their national vaccine safety system. Additionally, their opinions about what would be needed to ensure future capacity and capabilities for a global vaccine safety system were probed, along with models of collaboration for regulatory authorities and the private sector that address public safety issues

H3Africa and the African life sciences ecosystem: building sustainable innovation

Interest in genomics research in African populations is experiencing exponential growth. This enthusiasm stems in part from the recognition that the genomic diversity of African populations is a window of opportunity for innovations in postgenomics medicine, ecology, and evolutionary biology. The recently launched H3Africa initiative, for example, captures the energy and momentum of this interest. This interdisciplinary socio-technical analysis highlights the challenges that have beset previous genomics research activities in Africa, and looking ahead, suggests constructive ways H3Africa and similar large scale science efforts could usefully chart a new era of genomics and life sciences research in Africa that is locally productive and globally competitive. As independent African scholars and social scientists, we propose that any serious global omics science effort, including H3Africa, aiming to build genomics research capacity and capability in Africa, needs to fund the establishment of biobanks and the genomic analyses platforms within Africa. Equally they need to prioritize community engagement and bioinformatics capability an d the training of African scientists on these platform s. Historically , the financial, technological, and skills imbalance between Africa and developed countries has created exploitative frameworks of collaboration where African researchers have become merely facilitators of Western funded and conceived research agendas involving offshore expatriation of samples. Not surprisingly, very little funding was allocated to infrastructure and human capital development in the past. Moving forward, capacity building should materialize throughout the entire knowledge co-production trajectory: idea generation (e.g., brainstorming workshops for innovative hypotheses development by African scientists), data generation (e.g., genome sequencing), an d high-through put data analysis an d contextualization . Additionally, building skills for political science scholarship that questions the unchecked assumptions of the innovation performers be they funders, scientists, and social scientists, would enable collective innovation that is truly sustainable, ethical, and robust

Twenty-first century vaccinomics innovation systems: capacity building in the global South and the role of Product Development Partnerships (PDPs)

The availability of sequence information from publicly available complete genomes and data intensive sciences, together with next-generation sequencing technologies offer substantial promise for innovation in vaccinology and global public health in the beginning of the 21st century. This article presents an innovation analysis for the nascent field of vaccinomics by describing one of the major challenges in this endeavor: the need for capacities in “vaccinomics innovation systems” to support the developing countries involved in the creation and testing of new vaccines. In particular, we discuss the need for understanding how institutional frameworks can enhance capacities as intrinsic to a systems approach to health technology development. We focus our attention on the global South, meaning the technically less advanced and developing nations in Africa, Asia, and Latin America. This focus is timely and appropriate because the challenge for innovation in postgenomics medicine is markedly much greater in these regions where basic infrastructures are often underresourced and new or the anticipated institutional relationships can be fragile. Importantly, we examine the role of Product Development Partnerships (PDPs) as a 21st century organizational innovation that contributes to strengthening fragile institutions and capacity building. For vaccinomics innovation systems to stand the test of time in a context of global public health, local communities, knowledge, and cultures need to be collectively taken into account at all stages in programs for vaccinomics-guided vaccine development and delivery in the global South where the public health needs for rational vaccine development are urgent

An appeal to the global health community for a tripartite innovation: an ‘‘Essential Diagnostics List,’’ ‘‘Health in All Policies,’’ and ‘‘See-Through 21st Century Science and Ethics"

Diagnostics spanning a wide range of new biotechnologies, including proteomics, metabolomics, and nanotechnology, are emerging as companion tests to innovative medicines. In this Opinion, we present the rationale for promulgating an ‘‘Essential Diagnostics List.’’ Additionally, we explain the ways in which adopting a vision for ‘‘Health in All Policies’’ could link essential diagnostics with robust and timely societal outcomes such as sustainable development, human rights, gender parity, and alleviation of poverty. We do so in three ways. First, we propose the need for a new, ‘‘see through’’ taxonomy for knowledge-based innovation as we transition from the material industries (e.g., textiles, plastic, cement, glass) dominant in the 20th century to the anticipated knowledge industry of the 21st century. If knowledge is the currency of the present century, then it is sensible to adopt an approach that thoroughly examines scientific knowledge, starting with the production aims, methods, quality, distribution, access, and the ends it purports to serve. Second, we explain that this knowledge trajectory focus on innovation is crucial and applicable across all sectors, including public, private, or public–private partnerships, as it underscores the fact that scientific knowledge is a co-product of technology, human values, and social systems. By making the value systems embedded in scientific design and knowledge co-production transparent, we all stand to benefit from sustainable and transparent science. Third, we appeal to the global health community to consider the necessary qualities of good governance for 21st century organizations that will embark on developing essential diagnostics. These have importance not only for science and knowledge based innovation, but also for the ways in which we can build open, healthy, and peaceful civil societies today and for future generations