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New genomic techniques and their European Union reform. Potential policy changes and their implications.

ABSTRACT: The article discusses amendment options (no significant change, lowering of administrative burdens or exemption of certain products from the legislation) for the European Union (EU) authorization procedures of New Genomic Techniques' (NGT) products and their consequences for the sector and research institutions, particularly in the context of internal functioning, placing products on the market and international trade. A reform of the EU regulatory system requires a change in the procedures for the authorization of NGT products, otherwise EU researchers and investors may still be at a competitive disadvantage (as compared to Argentina, Brazil, Canada, United States or the United Kingdom) due to the inefficiency of the current system and the committee procedure for authorization. New legislation, currently being adopted in the United Kingdom is also presented for comparison.

SUBMITTER: Zimny T

PROVIDER: S-EPMC9562193 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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New genomic techniques and their European Union reform. Potential policy changes and their implications.

Zimny Tomasz T

Frontiers in bioengineering and biotechnology 20220930

The article discusses amendment options (no significant change, lowering of administrative burdens or exemption of certain products from the legislation) for the European Union (EU) authorization procedures of New Genomic Techniques' (NGT) products and their consequences for the sector and research institutions, particularly in the context of internal functioning, placing products on the market and international trade. A reform of the EU regulatory system requires a change in the procedures for ...[more]

PMID: 36246372

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Project description:Impact assessment (IA) of all major European Union (EU) policies is now mandatory. The form of IA used has been criticised for favouring corporate interests by overemphasising economic impacts and failing to adequately assess health impacts. Our study sought to assess how, why, and in what ways corporations, and particularly the tobacco industry, influenced the EU's approach to IA.In order to identify whether industry played a role in promoting this system of IA within the EU, we analysed internal documents from British American Tobacco (BAT) that were disclosed following a series of litigation cases in the United States. We combined this analysis with one of related literature and interviews with key informants. Our analysis demonstrates that from 1995 onwards BAT actively worked with other corporate actors to successfully promote a business-oriented form of IA that favoured large corporations. It appears that BAT favoured this form of IA because it could advance the company's European interests by establishing ground rules for policymaking that would: (i) provide an economic framework for evaluating all policy decisions, implicitly prioritising costs to businesses; (ii) secure early corporate involvement in policy discussions; (iii) bestow the corporate sector with a long-term advantage over other actors by increasing policymakers' dependence on information they supplied; and (iv) provide businesses with a persuasive means of challenging potential and existing legislation. The data reveal that an ensuing lobbying campaign, largely driven by BAT, helped secure binding changes to the EU Treaty via the Treaty of Amsterdam that required EU policymakers to minimise legislative burdens on businesses. Efforts subsequently focused on ensuring that these Treaty changes were translated into the application of a business orientated form of IA (cost-benefit analysis [CBA]) within EU policymaking procedures. Both the tobacco and chemical industries have since employed IA in apparent attempts to undermine key aspects of European policies designed to protect public health.Our findings suggest that BAT and its corporate allies have fundamentally altered the way in which all EU policy is made by making a business-oriented form of IA mandatory. This increases the likelihood that the EU will produce policies that advance the interests of major corporations, including those that produce products damaging to health, rather than in the interests of its citizens. Given that the public health community, focusing on health IA, has largely welcomed the increasing policy interest in IA, this suggests that urgent consideration is required of the ways in which IA can be employed to undermine, as well as support, effective public health policies.

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Dataset Information

New genomic techniques and their European Union reform. Potential policy changes and their implications.

Publications

New genomic techniques and their European Union reform. Potential policy changes and their implications.

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