The production process for cultivated foods usually starts with isolating cells from animals and ... more The production process for cultivated foods usually starts with isolating cells from animals and adapting them for sustained growth and scalability ex vivo through a cell line development phase. Given its importance, cell line development was selected as a key topic of focus by the APAC Regulatory Coordination Forum in 2024. The APAC Regulatory Coordination Forum White Paper on Cell Line Development identifies four current gaps and offers potential solutions and pathways for collaboration among academia, the industry, and food safety regulators.
This document serves as a valuable starting point to inform and empower regional regulators, companies, and researchers to facilitate internationally harmonised standards, guidelines, and recommendations on the food safety aspects of cell lines.
1. Cell line documentation: Proper documentation ensures the traceability, safety, and regulatory compliance of cell lines used in cultivated food production. Companies currently face challenges related to inconsistent data and documentation requirements, particularly around sourcing animal cells and their characterisation. This section recommends the creation of a “specifically named" guideline for cultivated food cell lines, inspired by existing guidelines from other sectors, as a means of enabling consensus around documentation requirements. In the short term, the development of toolkits that provide guidance on recommended data and documentation for companies to collate is suggested.
2. Defining cell line stability: Establishing appropriate guidelines for cell line stability remains a significant challenge. This section explores various approaches used by the industry to date, and potential best practices in line with practical hazards presented by changes in cell line characteristics during the production of cultivated foods. It recommends the need for coordinated guidelines, including preferred characteristics to monitor with associated cutoffs for allowable variability, that address the potential risks of genetic drift and phenotypic changes only where they could affect the quality and safety of cultivated food products.
3. Genetic modifications: Using genetic modifications for the development of high-quality cell lines presents opportunities for improving production efficiency. However, regulatory frameworks in the APAC region lack clarity on assessing the safety of genetically modified cell lines. This white paper recommends developing standardised criteria for assessing genetically modified cell lines. It also encourages the conduct of open-access research by relevant experts to advance understanding of the safety implications of these technologies, particularly for regulatory agencies.
4. Trade requirements: The regulatory landscape for cellular agriculture products is fragmented, with no clear international standards. This section outlines the need for coordinated international guidelines, particularly around the classification of cell lines, intellectual property, and trade barriers. This white paper emphasises the importance of APAC countries taking a leadership role in setting global standards, in collaboration with a variety of international standard-setting agencies, to promote the safety and marketability of cultivated food products.
The APAC Regulatory Coordination Forum will continue to work closely with companies, industry associations, think tanks, governmental agencies, and food regulators to support the development of scientific, risk-based frameworks to bring cultivated foods to market in a timely manner. Through this work, we will ensure that the APAC region is well-positioned to lead in this emerging sector and build a more secure and climate-resilient food system for all.
The international trade regime was a sea of tranquillity for a long time. It was the domain of tr... more The international trade regime was a sea of tranquillity for a long time. It was the domain of trade economists and trade lawyers, tucked away at the World Trade Organization (WTO) on the shores of Lake Geneva. The trade regime as it has developed is being undermined by the twin forces of geo‑political confrontation and geo‑economic fragmentation.
Examples for how trade is being utilised as a new battlefield abound: the curtailment or cancellation of energy deliveries by Russia to European countries, the initiation of trade sanctions by China against various products from Australia, and the trade war between China and the United States (US).
Domestic regulatory decisions involving matters of human health or the environment are increasing... more Domestic regulatory decisions involving matters of human health or the environment are increasingly coming under scrutiny by international courts and tribunals. One of the latest examples concerns an Australian law mandating the plain packaging of cigarettes, which is currently being challenged under both international investment and international trade law. Both of these fields are closely related and are governed by similar rules. However, despite their similarities, they also differ in important respects. This article analyzes the extent of the regulatory space afforded to states and World Trade Organization ("WTO") members in the international investment and international trade regimes. It does so by comparing the jurisprudence of investment tribunals regarding regulatory expropriations and the jurisprudence of the WTO dispute settlement organs in cases concerning human, animal or plant life or health, as well as cases concerning technical barriers to trade.
It's on again. This time it's Australia's wine industry that's under investigation in China for a... more It's on again. This time it's Australia's wine industry that's under investigation in China for allegedly violating anti-dumping rules
Non-State Actors have taken on increasingly important roles in international relations. This ency... more Non-State Actors have taken on increasingly important roles in international relations. This encyclopedia entry analyzes the concept of non-state actors, a superordinate concept that encompasses individuals as well as international organizations, corporations, non-governmental organizations, de facto regimes, trade associations, transnational corporations, terrorist groups and transnational criminal organizations. It then traces the historical evolution of the concept, describes the role of non-state actors in the negotiation and codification of international law, as well as in international litigation. Finally, the entry covers non-state actors and their capacity on peace and security matters.
German Abstract: Der Umgang mit Autonomen Waffensystemen (AWS) ist keine Zukunftsmusik mehr, sond... more German Abstract: Der Umgang mit Autonomen Waffensystemen (AWS) ist keine Zukunftsmusik mehr, sondern stellt fur das Volkerrecht und die internationale Politik eine grose Herausforderung dar. Der Beitrag skizziert die rechtlichen Voraussetzungen des humanitaren Volkerrechts fur die Verwendung von AWS und kommt zu dem Ergebnis, dass derzeit einem Einsatz von AWS aus rechtlichen Grunden erhebliche Bedenken gegenuber stehen. Der Artikel schliest mit einer Beschreibung moglicher zukunftiger Regelungsansatze fur AWS.English Abstract: The question over how to deal with autonomous weapon systems (AWS) is no longer an academic one, but presents challenges with respect to their compliance with international law and for international policy makers. The article describes the applicable international humanitarian law framework, specifically the principle of distinction and the principle of proportionality. It concludes that at least at this point and despite impressive technological advances in ...
Our submission is focussed on how Australia’s BITs can be modernised to ensure that the promotion... more Our submission is focussed on how Australia’s BITs can be modernised to ensure that the promotion and protection of investments is balanced against the need to safeguard policy space for legitimate public-welfare measures or ‘regulatory autonomy’. This discussion responds primarily to Question 4 of the questions for consideration outlined in the DFAT Discussion Paper, by providing our views on clauses that should be included in any renegotiated BITs or other investment agreements negotiated by Australia in the future.
This entry in the Max Planck Encyclopedia of International Procedural Law, titled Panel: Dispute ... more This entry in the Max Planck Encyclopedia of International Procedural Law, titled Panel: Dispute Settlement System of the World Trade Organization (WTO), comprehensively covers all aspects of dispute settlement before WTO panels, as well as panel proceedings within the overall WTO dispute settlement system. This includes informal and formal consultations; the establishment and composition of panels; the sequence of proceedings; access for non-disputing parties; and the role of of the WTO Secretariat. The article also covers various elements of the panel process, including terms of reference, the standard of review, the applicable rules of interpretation, questions of evidence, the use of experts, the confidentiality of panel proceedings, panel expenses, and impartiality. It finally touches on how developing countries participate in the panel process and what the consequences are of the WTO's Appellate Body suspension.
International standards are central to domestic rule-making processes. While these standards-deve... more International standards are central to domestic rule-making processes. While these standards-developed outside the WTO-are in and of themselves not binding, the SPS Agreement gives them a quasi-binding character as WTO members must provide scientific justification should they wish to deviate from international standards. Developing countries are particularly disadvantaged in the standard-making process.
Commentary on Article I WTO Agreement, focusing on the genesis and naming of the World Trade Orga... more Commentary on Article I WTO Agreement, focusing on the genesis and naming of the World Trade Organization.
We are experiencing a tumultuous period in global politics, with international economic governanc... more We are experiencing a tumultuous period in global politics, with international economic governance facing a period of great uncertainty. Meanwhile, since the de facto collapse of the WTO’s Doha Round, a plethora of preferential agreements has begun to supplant the WTO’s rule-making function and to regulate the previously separate fields of international trade law and international investment law. This Special Issue has two objectives: to contribute to a greater understanding of the dynamics of preferential agreements as a source of new norms of global governance and their impact on the existing international trade and investment regimes, and to identify the implications that these developments have for States in their capacity as treaty negotiators and domestic regulators.
Proceedings of the Annual Meeting (American Society of International Law), 2012
Over the last few years, the military landscape has undergone considerable modification. Not only... more Over the last few years, the military landscape has undergone considerable modification. Not only are we witnessing changes with regard to the adversaries that fight one another (consider the rise of what has been labeled "asymmetric warfare"), but the means by which armed conflict is carried out has undergone significant modification with more--and potentially more transformative--changes yet to come. The most obvious of these changes is already underway--and has come under some scrutiny. So-called unmanned aerial vehicles (UAVs) have conducted a vast and increasing number of reconnaissance missions. A smaller number of missions carry out armed attacks, with the operators of either type of mission connecting to their aircraft via satellite link from thousands of miles away. Similar attempts have been made by militaries around the world regarding sea and land warfare. All of these examples--whether operating by air, sea, or land--share one characteristic. These unmanned systems (UMS) are the visible pieces of a network that (at least until this point) still operates with direct human input. Building on these first steps toward greater autonomy for weapon systems, the next generations of UMS are designed to operate wholly independently from human input. From target selection, to the decision whether to employ weapon systems in the particular moment in time (and, if so, which weapons), autonomous weapon systems (AWS) will be in a position to carry out their missions without direct human input. This development changes the assumptions on which today's jus in bello is based and has the potential to alter fundamentally the perceptions of that field of international law. It is important to distinguish AWS from already existing technologies such as remotely operated systems or automated systems. Remotely operated systems have been in place for some time (with early examples going back to the end of the 19th century) and have received increased attention in recent years with the increase of attacks carried out by UAVs, including so-called targeted killings. (1) Automated weapons have been employed regularly over the last half century, one example being the use of cruise missiles. (2) AWS differ from these weapons. Unlike remotely operated systems and automated systems, AWS do not require a human operator to be in the loop. (3) Rather, by design they operate without direct human input. (4) This development raises legal, ethical, and political concerns. The challenge that AWS pose concerns their compatibility with today's jus in bello. In this context, two cornerstones of international humanitarian law are of particular relevance: the principle of distinction and the principle of proportionality. (5) Both principles are designed to protect civilians, but also allow for attacks, provided that the military advantage gained by the attack (as anticipated at the time of the attack) does not disproportionately harm the civilian population. The principle of distinction--spelled out in Article 48 of Additional Protocol I to the 1949 Geneva Conventions and refined in subsequent provisions--mandates that when carrying out an attack, combatants must distinguish between combatants (as well as military objects) and civilians (as well as civilian objects). Additional Protocol I not only prohibits attacks that target civilians only or that target purely civilian objects, but also bans the use of weapons that are by their nature indiscriminate. (6) These limitations become ever more important in a battlespace (as opposed to the conventional battlefield) in which civilian and military targets become increasingly intertwined. Some of the determinations with respect to the principle of distinction can be described quantitatively. While relying on largely quantitative analysis may be possible for some situations (imagine a tank which has specific characteristics that make it distinguishable from a car or a bus), others--especially those involving changing or unclear circumstances--are less amenable to mechanistic analysis (imagine a person carrying a tool over his shoulder that looks very similar to a weapon). …
On March 26, 2014, a World Trade Organization (WTO) panel issued its report on a dispute between ... more On March 26, 2014, a World Trade Organization (WTO) panel issued its report on a dispute between the European Union, Japan and the United States as complainants and China as respondent over access to so-called “rare earths,” as well as tungsten and molybdenum. The Panel found that China violated its obligations under the General Agreement on Tariffs and Trade 1994 (GATT) and the Accession Protocol by restricting exports of rare earths to manufacturers in other countries, while favoring Chinese competitors. Moreover, the Panel found that China could not invoke justifications under GATT Article XX to justify violation of the relevant provisions of its Accession Protocol and, in any case, China had not satisfied the requirements of Article XX. The Panel decision has implications for China’s right to regulate under the terms of its Accession Protocol as well as the nature of precedent in WTO dispute settlement. These issues will likely be further addressed by the Appellate Body following the United States’ and China’s appeal of the Panel Report.
The production process for cultivated foods usually starts with isolating cells from animals and ... more The production process for cultivated foods usually starts with isolating cells from animals and adapting them for sustained growth and scalability ex vivo through a cell line development phase. Given its importance, cell line development was selected as a key topic of focus by the APAC Regulatory Coordination Forum in 2024. The APAC Regulatory Coordination Forum White Paper on Cell Line Development identifies four current gaps and offers potential solutions and pathways for collaboration among academia, the industry, and food safety regulators.
This document serves as a valuable starting point to inform and empower regional regulators, companies, and researchers to facilitate internationally harmonised standards, guidelines, and recommendations on the food safety aspects of cell lines.
1. Cell line documentation: Proper documentation ensures the traceability, safety, and regulatory compliance of cell lines used in cultivated food production. Companies currently face challenges related to inconsistent data and documentation requirements, particularly around sourcing animal cells and their characterisation. This section recommends the creation of a “specifically named" guideline for cultivated food cell lines, inspired by existing guidelines from other sectors, as a means of enabling consensus around documentation requirements. In the short term, the development of toolkits that provide guidance on recommended data and documentation for companies to collate is suggested.
2. Defining cell line stability: Establishing appropriate guidelines for cell line stability remains a significant challenge. This section explores various approaches used by the industry to date, and potential best practices in line with practical hazards presented by changes in cell line characteristics during the production of cultivated foods. It recommends the need for coordinated guidelines, including preferred characteristics to monitor with associated cutoffs for allowable variability, that address the potential risks of genetic drift and phenotypic changes only where they could affect the quality and safety of cultivated food products.
3. Genetic modifications: Using genetic modifications for the development of high-quality cell lines presents opportunities for improving production efficiency. However, regulatory frameworks in the APAC region lack clarity on assessing the safety of genetically modified cell lines. This white paper recommends developing standardised criteria for assessing genetically modified cell lines. It also encourages the conduct of open-access research by relevant experts to advance understanding of the safety implications of these technologies, particularly for regulatory agencies.
4. Trade requirements: The regulatory landscape for cellular agriculture products is fragmented, with no clear international standards. This section outlines the need for coordinated international guidelines, particularly around the classification of cell lines, intellectual property, and trade barriers. This white paper emphasises the importance of APAC countries taking a leadership role in setting global standards, in collaboration with a variety of international standard-setting agencies, to promote the safety and marketability of cultivated food products.
The APAC Regulatory Coordination Forum will continue to work closely with companies, industry associations, think tanks, governmental agencies, and food regulators to support the development of scientific, risk-based frameworks to bring cultivated foods to market in a timely manner. Through this work, we will ensure that the APAC region is well-positioned to lead in this emerging sector and build a more secure and climate-resilient food system for all.
The international trade regime was a sea of tranquillity for a long time. It was the domain of tr... more The international trade regime was a sea of tranquillity for a long time. It was the domain of trade economists and trade lawyers, tucked away at the World Trade Organization (WTO) on the shores of Lake Geneva. The trade regime as it has developed is being undermined by the twin forces of geo‑political confrontation and geo‑economic fragmentation.
Examples for how trade is being utilised as a new battlefield abound: the curtailment or cancellation of energy deliveries by Russia to European countries, the initiation of trade sanctions by China against various products from Australia, and the trade war between China and the United States (US).
Domestic regulatory decisions involving matters of human health or the environment are increasing... more Domestic regulatory decisions involving matters of human health or the environment are increasingly coming under scrutiny by international courts and tribunals. One of the latest examples concerns an Australian law mandating the plain packaging of cigarettes, which is currently being challenged under both international investment and international trade law. Both of these fields are closely related and are governed by similar rules. However, despite their similarities, they also differ in important respects. This article analyzes the extent of the regulatory space afforded to states and World Trade Organization ("WTO") members in the international investment and international trade regimes. It does so by comparing the jurisprudence of investment tribunals regarding regulatory expropriations and the jurisprudence of the WTO dispute settlement organs in cases concerning human, animal or plant life or health, as well as cases concerning technical barriers to trade.
It's on again. This time it's Australia's wine industry that's under investigation in China for a... more It's on again. This time it's Australia's wine industry that's under investigation in China for allegedly violating anti-dumping rules
Non-State Actors have taken on increasingly important roles in international relations. This ency... more Non-State Actors have taken on increasingly important roles in international relations. This encyclopedia entry analyzes the concept of non-state actors, a superordinate concept that encompasses individuals as well as international organizations, corporations, non-governmental organizations, de facto regimes, trade associations, transnational corporations, terrorist groups and transnational criminal organizations. It then traces the historical evolution of the concept, describes the role of non-state actors in the negotiation and codification of international law, as well as in international litigation. Finally, the entry covers non-state actors and their capacity on peace and security matters.
German Abstract: Der Umgang mit Autonomen Waffensystemen (AWS) ist keine Zukunftsmusik mehr, sond... more German Abstract: Der Umgang mit Autonomen Waffensystemen (AWS) ist keine Zukunftsmusik mehr, sondern stellt fur das Volkerrecht und die internationale Politik eine grose Herausforderung dar. Der Beitrag skizziert die rechtlichen Voraussetzungen des humanitaren Volkerrechts fur die Verwendung von AWS und kommt zu dem Ergebnis, dass derzeit einem Einsatz von AWS aus rechtlichen Grunden erhebliche Bedenken gegenuber stehen. Der Artikel schliest mit einer Beschreibung moglicher zukunftiger Regelungsansatze fur AWS.English Abstract: The question over how to deal with autonomous weapon systems (AWS) is no longer an academic one, but presents challenges with respect to their compliance with international law and for international policy makers. The article describes the applicable international humanitarian law framework, specifically the principle of distinction and the principle of proportionality. It concludes that at least at this point and despite impressive technological advances in ...
Our submission is focussed on how Australia’s BITs can be modernised to ensure that the promotion... more Our submission is focussed on how Australia’s BITs can be modernised to ensure that the promotion and protection of investments is balanced against the need to safeguard policy space for legitimate public-welfare measures or ‘regulatory autonomy’. This discussion responds primarily to Question 4 of the questions for consideration outlined in the DFAT Discussion Paper, by providing our views on clauses that should be included in any renegotiated BITs or other investment agreements negotiated by Australia in the future.
This entry in the Max Planck Encyclopedia of International Procedural Law, titled Panel: Dispute ... more This entry in the Max Planck Encyclopedia of International Procedural Law, titled Panel: Dispute Settlement System of the World Trade Organization (WTO), comprehensively covers all aspects of dispute settlement before WTO panels, as well as panel proceedings within the overall WTO dispute settlement system. This includes informal and formal consultations; the establishment and composition of panels; the sequence of proceedings; access for non-disputing parties; and the role of of the WTO Secretariat. The article also covers various elements of the panel process, including terms of reference, the standard of review, the applicable rules of interpretation, questions of evidence, the use of experts, the confidentiality of panel proceedings, panel expenses, and impartiality. It finally touches on how developing countries participate in the panel process and what the consequences are of the WTO's Appellate Body suspension.
International standards are central to domestic rule-making processes. While these standards-deve... more International standards are central to domestic rule-making processes. While these standards-developed outside the WTO-are in and of themselves not binding, the SPS Agreement gives them a quasi-binding character as WTO members must provide scientific justification should they wish to deviate from international standards. Developing countries are particularly disadvantaged in the standard-making process.
Commentary on Article I WTO Agreement, focusing on the genesis and naming of the World Trade Orga... more Commentary on Article I WTO Agreement, focusing on the genesis and naming of the World Trade Organization.
We are experiencing a tumultuous period in global politics, with international economic governanc... more We are experiencing a tumultuous period in global politics, with international economic governance facing a period of great uncertainty. Meanwhile, since the de facto collapse of the WTO’s Doha Round, a plethora of preferential agreements has begun to supplant the WTO’s rule-making function and to regulate the previously separate fields of international trade law and international investment law. This Special Issue has two objectives: to contribute to a greater understanding of the dynamics of preferential agreements as a source of new norms of global governance and their impact on the existing international trade and investment regimes, and to identify the implications that these developments have for States in their capacity as treaty negotiators and domestic regulators.
Proceedings of the Annual Meeting (American Society of International Law), 2012
Over the last few years, the military landscape has undergone considerable modification. Not only... more Over the last few years, the military landscape has undergone considerable modification. Not only are we witnessing changes with regard to the adversaries that fight one another (consider the rise of what has been labeled "asymmetric warfare"), but the means by which armed conflict is carried out has undergone significant modification with more--and potentially more transformative--changes yet to come. The most obvious of these changes is already underway--and has come under some scrutiny. So-called unmanned aerial vehicles (UAVs) have conducted a vast and increasing number of reconnaissance missions. A smaller number of missions carry out armed attacks, with the operators of either type of mission connecting to their aircraft via satellite link from thousands of miles away. Similar attempts have been made by militaries around the world regarding sea and land warfare. All of these examples--whether operating by air, sea, or land--share one characteristic. These unmanned systems (UMS) are the visible pieces of a network that (at least until this point) still operates with direct human input. Building on these first steps toward greater autonomy for weapon systems, the next generations of UMS are designed to operate wholly independently from human input. From target selection, to the decision whether to employ weapon systems in the particular moment in time (and, if so, which weapons), autonomous weapon systems (AWS) will be in a position to carry out their missions without direct human input. This development changes the assumptions on which today's jus in bello is based and has the potential to alter fundamentally the perceptions of that field of international law. It is important to distinguish AWS from already existing technologies such as remotely operated systems or automated systems. Remotely operated systems have been in place for some time (with early examples going back to the end of the 19th century) and have received increased attention in recent years with the increase of attacks carried out by UAVs, including so-called targeted killings. (1) Automated weapons have been employed regularly over the last half century, one example being the use of cruise missiles. (2) AWS differ from these weapons. Unlike remotely operated systems and automated systems, AWS do not require a human operator to be in the loop. (3) Rather, by design they operate without direct human input. (4) This development raises legal, ethical, and political concerns. The challenge that AWS pose concerns their compatibility with today's jus in bello. In this context, two cornerstones of international humanitarian law are of particular relevance: the principle of distinction and the principle of proportionality. (5) Both principles are designed to protect civilians, but also allow for attacks, provided that the military advantage gained by the attack (as anticipated at the time of the attack) does not disproportionately harm the civilian population. The principle of distinction--spelled out in Article 48 of Additional Protocol I to the 1949 Geneva Conventions and refined in subsequent provisions--mandates that when carrying out an attack, combatants must distinguish between combatants (as well as military objects) and civilians (as well as civilian objects). Additional Protocol I not only prohibits attacks that target civilians only or that target purely civilian objects, but also bans the use of weapons that are by their nature indiscriminate. (6) These limitations become ever more important in a battlespace (as opposed to the conventional battlefield) in which civilian and military targets become increasingly intertwined. Some of the determinations with respect to the principle of distinction can be described quantitatively. While relying on largely quantitative analysis may be possible for some situations (imagine a tank which has specific characteristics that make it distinguishable from a car or a bus), others--especially those involving changing or unclear circumstances--are less amenable to mechanistic analysis (imagine a person carrying a tool over his shoulder that looks very similar to a weapon). …
On March 26, 2014, a World Trade Organization (WTO) panel issued its report on a dispute between ... more On March 26, 2014, a World Trade Organization (WTO) panel issued its report on a dispute between the European Union, Japan and the United States as complainants and China as respondent over access to so-called “rare earths,” as well as tungsten and molybdenum. The Panel found that China violated its obligations under the General Agreement on Tariffs and Trade 1994 (GATT) and the Accession Protocol by restricting exports of rare earths to manufacturers in other countries, while favoring Chinese competitors. Moreover, the Panel found that China could not invoke justifications under GATT Article XX to justify violation of the relevant provisions of its Accession Protocol and, in any case, China had not satisfied the requirements of Article XX. The Panel decision has implications for China’s right to regulate under the terms of its Accession Protocol as well as the nature of precedent in WTO dispute settlement. These issues will likely be further addressed by the Appellate Body following the United States’ and China’s appeal of the Panel Report.
Elgar Encyclopedia of International Economic Law, 2023
This chapter in the forthcoming Elgar Encyclopedia of International Economic Law examines the fol... more This chapter in the forthcoming Elgar Encyclopedia of International Economic Law examines the following topics with respect to Australia: trade; investment; financial regulation; and artificial intelligence. Further information about Australia – including the legislative process, the relationship of legislation with international law, the implementation of international treaties, and Australia’s membership of international bodies – is incorporated into each part as relevant.
The Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) is a complex agreement under... more The Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) is a complex agreement under the umbrella of the World Trade Organization (WTO) and concerns the interplay between governmental measures concerning risk for human, animal and plant life or health, the necessary scientific evidence supporting such measures and the inherent uncertainty of scientific inquiries. As such, it sits at the forefront of a larger discussion that animates international trade law, ie the differentiation between protectionist measures from those that are borne out of real concern for protecting human, animal plant life or health.
This debate in turn is embedded into a larger conversation in international economic law and policy circles: the delicate balance between the legitimate concerns of governments aimed at matters such as health and environmental safety as well as consumer protection on one hand and the idea of a liberal economic order that has prevailed in the aftermath of WW II, on the other.
Share Radio Afternoon, Interview with Ed Bowsher, 1 February 2017.
Audio is available at https:... more Share Radio Afternoon, Interview with Ed Bowsher, 1 February 2017.
International trade law and international investment law have traditionally been regarded as sepa... more International trade law and international investment law have traditionally been regarded as separate legal fields. This is no longer the case: it is becoming increasingly apparent that the two fields share a number of characteristics. The dispute over plain packaging of cigarettes made clear that tribunals concerned with international trade law and international investment law have to address the question of how much regulatory autonomy governments have under the respective treaty regimes. Finding the proper balance between liberalizing trade and promoting investment on one hand and providing governments the required regulatory autonomy while limiting abuse on the other, is an important task for international economic law in the future. This project uses the experience of international trade law as a matrix for a potential future development of international investment law and shows how the parallel though temporally shifted development is important for states in that they are more easily able to predict the viability of future regulatory decisions.
Presentation on autonomous weapon systems at the 2014 Annual Meeting of the American Society of I... more Presentation on autonomous weapon systems at the 2014 Annual Meeting of the American Society of International Law.
This panel addressed the legal, ethical and political challenges posed by the development of increasingly autonomous weapons systems. Analyzing autonomous weapon systems through the lenses of international humanitarian law, international human rights law, and international criminal law, the panel considered what legal or ethical limits, if any, should be placed on the use of autonomous weapons systems. It also touched up on who should be held accountable for international law violations during the deployment of autonomous weapon systems.
Commentaries on World Trade Law: Volume 4 Technical Barriers and SPS Measures, 2023
Non-tariff barriers have long overtaken tariff barriers as the focal points of governmental inter... more Non-tariff barriers have long overtaken tariff barriers as the focal points of governmental interventions in international trading relations and as a matter of WTO law. This development towards greater prominence of non-tariff barriers was already evident prior to the creation of the WTO through various plurilateral codes on matters as varied as trade remedies (anti-dumping, subsidies and safeguards) as well as various subject specific codes.
One of these subject matters was the 1979 Agreement on Technical Barriers to Trade (Document code LT/TR/A/5), often referred to as the “Standards Code”. Its creation was a recognition of the growing importance of international standards for international trade – and the ability of governments to impede international trade by not adhering to them.
The Uruguay Round brought to light the increasing relevance of and concerns over barriers to agricultural trade being used for protectionist purposes. While the Standards Code contained some rules on sanitary and phytosanitary measures, negotiations were bifurcated on a heavily revised Agreement on Technical Barriers to Trade (TBT Agreement) and to create a new Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement).
Both of these agreements came into force with the creation of the WTO on 1 January 1995 and constitute a major development of WTO law and governance. Unlike the GATT from which they emerged, they extend beyond the prevention of discriminatory measures. From a governance perspective, they encourage WTO Members to use international standards. From a legal perspective, they elevate non-binding standards formulated outside of the WTO into legally binding documents (which in turn raises questions over the ability of all WTO Members to take part in these standard-setting processes). Finally, through a variety of means such as requirements of notification for TBT and SPS measures and the creation of points of inquiry, both agreements contribute to greater administrative transparency.
The agreements covered in this volume are highly significant as a matter of law and as a matter of international economic governance. Some of the most well-known and controversial disputes have played out over technical barriers to trade and sanitary and phytosanitary measures. With respect to the TBT Agreement, these are US—COOL, US—Tuna II, US—Clove Cigarettes, and perhaps most famously Australia—Tobacco Plain Packaging. Cases concerning the SPS Agreement are similarly well-known, to wit: EC—Hormones and EC—Biotech.
Many of the cases surrounding the TBT and SPS agreements are, at first blush, technocratic in nature. But many are also highly contentious because they touch on global common goods such as the protection of food safety in particular and health more generally, as well as of the environment. They show, often in plain sight, the significant degree of interlinkage between the trade regime and the other areas of international governance.
Food insecurity has taken centre stage due to a growing global population, changing weather patte... more Food insecurity has taken centre stage due to a growing global population, changing weather patterns, regional conflicts and a rising tide of domestic policies. Yet, the relationship between food safety and food security remains underexplored. Operationalising the concept of sustainable food systems (SFS), both politically and legally, within international trade law offers a way forward.
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Papers by Markus Wagner
This document serves as a valuable starting point to inform and empower regional regulators, companies, and researchers to facilitate internationally harmonised standards, guidelines, and recommendations on the food safety aspects of cell lines.
1. Cell line documentation: Proper documentation ensures the traceability, safety, and regulatory compliance of cell lines used in cultivated food production. Companies currently face challenges related to inconsistent data and documentation requirements, particularly around sourcing animal cells and their characterisation. This section recommends the creation of a “specifically named" guideline for cultivated food cell lines, inspired by existing guidelines from other sectors, as a means of enabling consensus around documentation requirements. In the short term, the development of toolkits that provide guidance on recommended data and documentation for companies to collate is suggested.
2. Defining cell line stability: Establishing appropriate guidelines for cell line stability remains a significant challenge. This section explores various approaches used by the industry to date, and potential best practices in line with practical hazards presented by changes in cell line characteristics during the production of cultivated foods. It recommends the need for coordinated guidelines, including preferred characteristics to monitor with associated cutoffs for allowable variability, that address the potential risks of genetic drift and phenotypic changes only where they could affect the quality and safety of cultivated food products.
3. Genetic modifications: Using genetic modifications for the development of high-quality cell lines presents opportunities for improving production efficiency. However, regulatory frameworks in the APAC region lack clarity on assessing the safety of genetically modified cell lines. This white paper recommends developing standardised criteria for assessing genetically modified cell lines. It also encourages the conduct of open-access research by relevant experts to advance understanding of the safety implications of these technologies, particularly for regulatory agencies.
4. Trade requirements: The regulatory landscape for cellular agriculture products is fragmented, with no clear international standards. This section outlines the need for coordinated international guidelines, particularly around the classification of cell lines, intellectual property, and trade barriers. This white paper emphasises the importance of APAC countries taking a leadership role in setting global standards, in collaboration with a variety of international standard-setting agencies, to promote the safety and marketability of cultivated food products.
The APAC Regulatory Coordination Forum will continue to work closely with companies, industry associations, think tanks, governmental agencies, and food regulators to support the development of scientific, risk-based frameworks to bring cultivated foods to market in a timely manner. Through this work, we will ensure that the APAC region is well-positioned to lead in this emerging sector and build a more secure and climate-resilient food system for all.
Examples for how trade is being utilised as a new battlefield abound: the curtailment or cancellation of energy deliveries by Russia to European countries, the initiation of trade sanctions by China against various products from Australia, and the trade war between China and the United States (US).
This document serves as a valuable starting point to inform and empower regional regulators, companies, and researchers to facilitate internationally harmonised standards, guidelines, and recommendations on the food safety aspects of cell lines.
1. Cell line documentation: Proper documentation ensures the traceability, safety, and regulatory compliance of cell lines used in cultivated food production. Companies currently face challenges related to inconsistent data and documentation requirements, particularly around sourcing animal cells and their characterisation. This section recommends the creation of a “specifically named" guideline for cultivated food cell lines, inspired by existing guidelines from other sectors, as a means of enabling consensus around documentation requirements. In the short term, the development of toolkits that provide guidance on recommended data and documentation for companies to collate is suggested.
2. Defining cell line stability: Establishing appropriate guidelines for cell line stability remains a significant challenge. This section explores various approaches used by the industry to date, and potential best practices in line with practical hazards presented by changes in cell line characteristics during the production of cultivated foods. It recommends the need for coordinated guidelines, including preferred characteristics to monitor with associated cutoffs for allowable variability, that address the potential risks of genetic drift and phenotypic changes only where they could affect the quality and safety of cultivated food products.
3. Genetic modifications: Using genetic modifications for the development of high-quality cell lines presents opportunities for improving production efficiency. However, regulatory frameworks in the APAC region lack clarity on assessing the safety of genetically modified cell lines. This white paper recommends developing standardised criteria for assessing genetically modified cell lines. It also encourages the conduct of open-access research by relevant experts to advance understanding of the safety implications of these technologies, particularly for regulatory agencies.
4. Trade requirements: The regulatory landscape for cellular agriculture products is fragmented, with no clear international standards. This section outlines the need for coordinated international guidelines, particularly around the classification of cell lines, intellectual property, and trade barriers. This white paper emphasises the importance of APAC countries taking a leadership role in setting global standards, in collaboration with a variety of international standard-setting agencies, to promote the safety and marketability of cultivated food products.
The APAC Regulatory Coordination Forum will continue to work closely with companies, industry associations, think tanks, governmental agencies, and food regulators to support the development of scientific, risk-based frameworks to bring cultivated foods to market in a timely manner. Through this work, we will ensure that the APAC region is well-positioned to lead in this emerging sector and build a more secure and climate-resilient food system for all.
Examples for how trade is being utilised as a new battlefield abound: the curtailment or cancellation of energy deliveries by Russia to European countries, the initiation of trade sanctions by China against various products from Australia, and the trade war between China and the United States (US).
This debate in turn is embedded into a larger conversation in international economic law and policy circles: the delicate balance between the legitimate concerns of governments aimed at matters such as health and environmental safety as well as consumer protection on one hand and the idea of a liberal economic order that has prevailed in the aftermath of WW II, on the other.
Audio is available at https://www.shareradio.co.uk/podcasts/trump-travel-ban-blocked-by-us-courts-06-feb-17.
This panel addressed the legal, ethical and political challenges posed by the development of increasingly autonomous weapons systems. Analyzing autonomous weapon systems through the lenses of international humanitarian law, international human rights law, and international criminal law, the panel considered what legal or ethical limits, if any, should be placed on the use of autonomous weapons systems. It also touched up on who should be held accountable for international law violations during the deployment of autonomous weapon systems.
One of these subject matters was the 1979 Agreement on Technical Barriers to Trade (Document code LT/TR/A/5), often referred to as the “Standards Code”. Its creation was a recognition of the growing importance of international standards for international trade – and the ability of governments to impede international trade by not adhering to them.
The Uruguay Round brought to light the increasing relevance of and concerns over barriers to agricultural trade being used for protectionist purposes. While the Standards Code contained some rules on sanitary and phytosanitary measures, negotiations were bifurcated on a heavily revised Agreement on Technical Barriers to Trade (TBT Agreement) and to create a new Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement).
Both of these agreements came into force with the creation of the WTO on 1 January 1995 and constitute a major development of WTO law and governance. Unlike the GATT from which they emerged, they extend beyond the prevention of discriminatory measures. From a governance perspective, they encourage WTO Members to use international standards. From a legal perspective, they elevate non-binding standards formulated outside of the WTO into legally binding documents (which in turn raises questions over the ability of all WTO Members to take part in these standard-setting processes). Finally, through a variety of means such as requirements of notification for TBT and SPS measures and the creation of points of inquiry, both agreements contribute to greater administrative transparency.
The agreements covered in this volume are highly significant as a matter of law and as a matter of international economic governance. Some of the most well-known and controversial disputes have played out over technical barriers to trade and sanitary and phytosanitary measures. With respect to the TBT Agreement, these are US—COOL, US—Tuna II, US—Clove Cigarettes, and perhaps most famously Australia—Tobacco Plain Packaging. Cases concerning the SPS Agreement are similarly well-known, to wit: EC—Hormones and EC—Biotech.
Many of the cases surrounding the TBT and SPS agreements are, at first blush, technocratic in nature. But many are also highly contentious because they touch on global common goods such as the protection of food safety in particular and health more generally, as well as of the environment. They show, often in plain sight, the significant degree of interlinkage between the trade regime and the other areas of international governance.