| Autor: |
Diependaele L; Lisa Diependaele, LL.M., is an Assistant Academic Staff member at the Department of Philosophy and Moral Sciences at Ghent University. She obtained a M.A. in Moral Sciences (Ethics) at Ghent University (Belgium) in 2011, and a LL.M. in International and European Law at the Vrije Universiteit Brussel (VUB, Belgium) in 2012. Julian Cockbain, D.Phil., is a Consultant European Patent Attorney based in Gent, Belgium. After taking a degree and a doctorate in chemistry at Oxford University, he joined the patent and trademark attorney firm Dehns in London in 1979, qualifying as a UK patent attorney in 1983 and as a European Patent Attorney in 1984. He was appointed partner at Dehns in 1985, a position he held until 2012. He has published widely on patent-related matters. Sigrid Sterckx, Ph.D., is Professor of Ethics and Political and Social Philosophy at the Department of Philosophy and Moral Sciences of Ghent University. She lectures courses in theoretical and applied ethics as well as social and political philosophy. Her current research projects focus on: patenting in biomedicine and genomics; human tissue research and biobanking; organ transplantation; end-of-life decisions; and global justice. She has published widely on these issues. Diependaele, Cockbain, and Sterckx are all members of the Bioethics Institute Gent., Cockbain J; Lisa Diependaele, LL.M., is an Assistant Academic Staff member at the Department of Philosophy and Moral Sciences at Ghent University. She obtained a M.A. in Moral Sciences (Ethics) at Ghent University (Belgium) in 2011, and a LL.M. in International and European Law at the Vrije Universiteit Brussel (VUB, Belgium) in 2012. Julian Cockbain, D.Phil., is a Consultant European Patent Attorney based in Gent, Belgium. After taking a degree and a doctorate in chemistry at Oxford University, he joined the patent and trademark attorney firm Dehns in London in 1979, qualifying as a UK patent attorney in 1983 and as a European Patent Attorney in 1984. He was appointed partner at Dehns in 1985, a position he held until 2012. He has published widely on patent-related matters. Sigrid Sterckx, Ph.D., is Professor of Ethics and Political and Social Philosophy at the Department of Philosophy and Moral Sciences of Ghent University. She lectures courses in theoretical and applied ethics as well as social and political philosophy. Her current research projects focus on: patenting in biomedicine and genomics; human tissue research and biobanking; organ transplantation; end-of-life decisions; and global justice. She has published widely on these issues. Diependaele, Cockbain, and Sterckx are all members of the Bioethics Institute Gent., Sterckx S; Lisa Diependaele, LL.M., is an Assistant Academic Staff member at the Department of Philosophy and Moral Sciences at Ghent University. She obtained a M.A. in Moral Sciences (Ethics) at Ghent University (Belgium) in 2011, and a LL.M. in International and European Law at the Vrije Universiteit Brussel (VUB, Belgium) in 2012. Julian Cockbain, D.Phil., is a Consultant European Patent Attorney based in Gent, Belgium. After taking a degree and a doctorate in chemistry at Oxford University, he joined the patent and trademark attorney firm Dehns in London in 1979, qualifying as a UK patent attorney in 1983 and as a European Patent Attorney in 1984. He was appointed partner at Dehns in 1985, a position he held until 2012. He has published widely on patent-related matters. Sigrid Sterckx, Ph.D., is Professor of Ethics and Political and Social Philosophy at the Department of Philosophy and Moral Sciences of Ghent University. She lectures courses in theoretical and applied ethics as well as social and political philosophy. Her current research projects focus on: patenting in biomedicine and genomics; human tissue research and biobanking; organ transplantation; end-of-life decisions; and global justice. She has published widely on these issues. Diependaele, Cockbain, and Sterckx are all members of the Bioethics Institute Gent. |
| Abstrakt: |
Advancements in the field of biotechnology have accelerated the development of drugs that are manufactured from cultures of living cells, commonly referred to as "biologics." Due to the complexity of the production process, generic biologics are unlikely to be chemically identical to the reference product, and accordingly are referred to as "biosimilars." Encouraging the development of biosimilars has been presented as the key solution to decrease prices and increase access to biologics, but the development and use of biosimilars continues to raise problems, none of which can easily be addressed. Developing a biosimilar requires considerable time and financial resources, and legitimate safety concerns necessitate elaborate clinical testing of biosimilars. As a consequence, the introduction of biosimilars onto the market has not resulted in significant price reductions, and concerns regarding the substitution and interchangeability of original biologics with biosimilars persist. This article will explain how the biologics production process distorts the trade-offs that traditionally guided both patent protection and regulatory exclusivities: disclosure as a key condition for benefiting from the corresponding monopoly position. Hence, we propose establishing a mechanism of mandatory deposit of the original biologic's cell line at the stage of the regulatory approval as the most effective remedy. |
