Conditions for technological solutions in a COVID-19 exit strategy, with particular focus on the legal and societal conditions external link

Abstract

Which legal, ethical and societal conditions need to be fulfilled for the use of digital solutions in managing the COVID-19 exit-strategy? This was the central question of this research. Digital technologies can be part of solutions to societal challenges, for example to manage the pandemic and lead the Netherlands out of the COVID-19 crisis. One set of technologies that figured particularly prominently in that debate was the use of contact tracing apps like the CoronaMelder, as well as digital vaccination passports (CoronaCheck app). In the Netherlands, Europe and worldwide, the introduction of apps such as the CoronaMelder or the CoronaCheck app was met by criticism from experts, politicians, civil society and academics. Concerns range from the lack of evidence for the effectiveness of such apps, uncertainty about the conditions that need to be fulfilled to reach their goal, our growing dependency on technology companies up to worries about the fundamental rights and adverse effects for vulnerable groups, such as elderly or users without a smart phone. The overall goal of the research was to monitor the societal, ethical and legal implications of implementing apps like the CoronaMelder, and from that draw lessons for the future use of ‘technology-assisted governance solutions’. One important conclusion from the report is that ‘there are no easy technological fixes, and in order for a technological solution to work, it needs to be part of a broader vision on what such a solution needs to function in society, achieve its intended goals and respect the fundamental rights of users as well as non-users.’ The report also offers critical reflections on the need for democratic legitimisation and accountability, the role of big tech and insights on the societal impact of the CoronaMelder and other technological solutions.

covid-19, frontpage, Informatierecht

Bibtex

Article{Helberger2021bb, title = {Conditions for technological solutions in a COVID-19 exit strategy, with particular focus on the legal and societal conditions}, author = {Helberger, N. and Eskens, S. and Strycharz, J. and Bouchè, G. and van Hoboken, J. and Mil, J. van and Toh, J.}, url = {https://www.ivir.nl/publicaties/download/covid-report-1.pdf}, year = {0913}, date = {2021-09-13}, abstract = {Which legal, ethical and societal conditions need to be fulfilled for the use of digital solutions in managing the COVID-19 exit-strategy? This was the central question of this research. Digital technologies can be part of solutions to societal challenges, for example to manage the pandemic and lead the Netherlands out of the COVID-19 crisis. One set of technologies that figured particularly prominently in that debate was the use of contact tracing apps like the CoronaMelder, as well as digital vaccination passports (CoronaCheck app). In the Netherlands, Europe and worldwide, the introduction of apps such as the CoronaMelder or the CoronaCheck app was met by criticism from experts, politicians, civil society and academics. Concerns range from the lack of evidence for the effectiveness of such apps, uncertainty about the conditions that need to be fulfilled to reach their goal, our growing dependency on technology companies up to worries about the fundamental rights and adverse effects for vulnerable groups, such as elderly or users without a smart phone. The overall goal of the research was to monitor the societal, ethical and legal implications of implementing apps like the CoronaMelder, and from that draw lessons for the future use of ‘technology-assisted governance solutions’. One important conclusion from the report is that ‘there are no easy technological fixes, and in order for a technological solution to work, it needs to be part of a broader vision on what such a solution needs to function in society, achieve its intended goals and respect the fundamental rights of users as well as non-users.’ The report also offers critical reflections on the need for democratic legitimisation and accountability, the role of big tech and insights on the societal impact of the CoronaMelder and other technological solutions.}, keywords = {covid-19, frontpage, Informatierecht}, }

Why a COVID IP Waiver Is not a Good Strategy external link

2021

Abstract

The COVID-19 pandemic has a profound influence on all aspects of society. The development of successful vaccines in record speed is almost a miracle. But despite the successful development and approval of multiple vaccines, many people still die of this terrible disease, and there is an urgent need to see more vaccines manufactured and distributed across the globe. The proposed COVID-19 IP waiver has been touted by some to be the perfect solution to a terrible problem. We all agree that there is a terrible problem of insufficient vaccines to inoculate the world population. An IP waiver is not a good strategy however, to tackle this crisis. There are multiple more effective solution conceivable which do not require a very disruptive IP waiver. The problem of insufficient supply is much more complicated than a simple IP waiver suggests. This is a complex ecosystem, and there are many moving parts. Moreover, IP rights are only part of the problem relating to more supply of vaccine or therapeutics. In view of the complexities, it will probably take many months to negotiate any kind of IP waiver system that would be acceptable to all WTO member states, if consensus could be reached at all. And the end result is likely to satisfy very few if any countries. The legality of an IP waiver can be doubted, and it would require retro-active effect, a concept that should be extremely sparingly used. A multitude of complex issues needs to be sorted out. There are hundreds of patents to navigate. A waiver to the equally patented vaccine platform technology (covering many patents), which may be used to develop any other vaccine, will make those companies who have invested heavily into developing it very nervous indeed, to say the least. Crucial manufacturing know-how is often not protected by IP rights, but is kept secret, and it will be difficult to force companies to disclose that information, also because one does not know what to ask for. The present IP waiver proposal also provides for a disclosure of commercially very sensitive information. Companies did not have a chance to adapt their regulatory disclosure strategies to this new reality, which means that information which will be disclosed under the waiver could very well have a major negative impact on future innovation strategies, and may also hamper competitive advantage or leverage. Market exclusivity is arguably not covered by the IP waiver, which means that separate national statutory intervention will be required to ensure that this market exclusivity is set aside, absent of which the IP waiver cannot have any practical effect. A quick and determined use of compulsory licensing could be a better way forward, as they have the potential to be a powerful tool. There are inefficiencies in using the instrument however, and invoking them when the need is high will require a relatively long lead time before they sort practical effect. They also require additional statutory intervention to ensure that regulatory exclusivities do not block their practical effect. And they might not necessarily work as well with low and middle-income countries, who would have less leverage in the negotiations. More efficient solutions can be arrived at by introducing hard clauses into contracts in the context of push and pull mechanisms. Those obligations are much more likely to result in more supply in the shorter to medium term if they are agreed upon long before the vaccine enters the market. It is obviously too late for the contracts that have been concluded in the past, but it should be a template for the future.

access to drugs, covid-19, data exclusivity, frontpage, intellectual property rights, Intellectuele eigendom, market exclusivity, Octrooirecht, pandemic, patents, population health, SARS-CoV-2, trade secrets, TRIPS, vaccines, waiver, WTO

Bibtex

Article{Bostyn2021, title = {Why a COVID IP Waiver Is not a Good Strategy}, author = {Bostyn, S.}, url = {https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3843327}, year = {0517}, date = {2021-05-17}, abstract = {The COVID-19 pandemic has a profound influence on all aspects of society. The development of successful vaccines in record speed is almost a miracle. But despite the successful development and approval of multiple vaccines, many people still die of this terrible disease, and there is an urgent need to see more vaccines manufactured and distributed across the globe. The proposed COVID-19 IP waiver has been touted by some to be the perfect solution to a terrible problem. We all agree that there is a terrible problem of insufficient vaccines to inoculate the world population. An IP waiver is not a good strategy however, to tackle this crisis. There are multiple more effective solution conceivable which do not require a very disruptive IP waiver. The problem of insufficient supply is much more complicated than a simple IP waiver suggests. This is a complex ecosystem, and there are many moving parts. Moreover, IP rights are only part of the problem relating to more supply of vaccine or therapeutics. In view of the complexities, it will probably take many months to negotiate any kind of IP waiver system that would be acceptable to all WTO member states, if consensus could be reached at all. And the end result is likely to satisfy very few if any countries. The legality of an IP waiver can be doubted, and it would require retro-active effect, a concept that should be extremely sparingly used. A multitude of complex issues needs to be sorted out. There are hundreds of patents to navigate. A waiver to the equally patented vaccine platform technology (covering many patents), which may be used to develop any other vaccine, will make those companies who have invested heavily into developing it very nervous indeed, to say the least. Crucial manufacturing know-how is often not protected by IP rights, but is kept secret, and it will be difficult to force companies to disclose that information, also because one does not know what to ask for. The present IP waiver proposal also provides for a disclosure of commercially very sensitive information. Companies did not have a chance to adapt their regulatory disclosure strategies to this new reality, which means that information which will be disclosed under the waiver could very well have a major negative impact on future innovation strategies, and may also hamper competitive advantage or leverage. Market exclusivity is arguably not covered by the IP waiver, which means that separate national statutory intervention will be required to ensure that this market exclusivity is set aside, absent of which the IP waiver cannot have any practical effect. A quick and determined use of compulsory licensing could be a better way forward, as they have the potential to be a powerful tool. There are inefficiencies in using the instrument however, and invoking them when the need is high will require a relatively long lead time before they sort practical effect. They also require additional statutory intervention to ensure that regulatory exclusivities do not block their practical effect. And they might not necessarily work as well with low and middle-income countries, who would have less leverage in the negotiations. More efficient solutions can be arrived at by introducing hard clauses into contracts in the context of push and pull mechanisms. Those obligations are much more likely to result in more supply in the shorter to medium term if they are agreed upon long before the vaccine enters the market. It is obviously too late for the contracts that have been concluded in the past, but it should be a template for the future.}, keywords = {access to drugs, covid-19, data exclusivity, frontpage, intellectual property rights, Intellectuele eigendom, market exclusivity, Octrooirecht, pandemic, patents, population health, SARS-CoV-2, trade secrets, TRIPS, vaccines, waiver, WTO}, }

Netherlands external link

Abstract

Contact tracing apps for smartphones, thermal scanners, face recognition technology: high hopes have been placed by both local administrations and national governments in applications and devices like these, aimed at containing the outbreak of the virus. The new publication Automated Decision-Making Systems in the COVID-19 Pandemic: A European Perspective gathers detailed examples of ADM systems in use, compiled by a network of researchers covering 16 countries. It provides an initial mapping and exploration of ADM systems implemented throughout Europe as a consequence of the COVID-19 outbreak.

covid-19, frontpage, mobile health apps, Technologie en recht

Bibtex

Chapter{Appelman2020b, title = {Netherlands}, author = {Appelman, N. and Fahy, R.}, url = {https://algorithmwatch.org/wp-content/uploads/2020/08/ADM-systems-in-the-Covid-19-pandemic-Report-by-AW-BSt-Sept-2020.pdf}, year = {0901}, date = {2020-09-01}, abstract = {Contact tracing apps for smartphones, thermal scanners, face recognition technology: high hopes have been placed by both local administrations and national governments in applications and devices like these, aimed at containing the outbreak of the virus. The new publication Automated Decision-Making Systems in the COVID-19 Pandemic: A European Perspective gathers detailed examples of ADM systems in use, compiled by a network of researchers covering 16 countries. It provides an initial mapping and exploration of ADM systems implemented throughout Europe as a consequence of the COVID-19 outbreak.}, keywords = {covid-19, frontpage, mobile health apps, Technologie en recht}, }