Future of the EU biotechnology and biomanufacturing sector: leveraging research, boosting innovation and enhancing competitiveness

Amendments tabled for the plenary sitting on this text, in their own numbering series. This is a different set from the committee amendments tracked elsewhere on AmendEU, and is not counted in any of the site’s amendment totals.

1. Amendment 1Motion for a resolution · Citation 2 a (new)
   Amendment

   – having regard to the UN Universal Declaration on the Human Genome and Human Rights;

   official amendment document ↗
2. Amendment 2Motion for a resolution · Recital S a (new)
   Amendment

   Sa. whereas such a framework and the ethical foundation of the EU should be based on core values such as the inviolability of human dignity, the integrity of the person, the primacy of the human being over the sole interests of science or industry, the prohibition of reproductive cloning and eugenic practices, the requirement of free and informed consent for any medical intervention, the prohibition of financial profit from the human body and its parts, the non-patentability of living human matter, and the rejection of discrimination based on genetic characteristics; whereas this must include, among other things, strict compliance with rules on genetically modified organisms (GMOs), the proh…

   Excerpt — full text in the official PDF.
   official amendment document ↗
3. Amendment 3Motion for a resolution · Paragraph 1
   Current text

   1. Emphasises the growth potential of the European biotechnology and biomanufacturing sector and the need for the EU to remain world-leading in this field; underlines the commitment to the principles of better regulation and lawmaking, simplification and administrative burden reduction; underlines that the simplification of EU legislation must not endanger any of the fundamental rights of citizens, workers and businesses or risk regulatory uncertainty; believes that any simplification proposal should not be rushed and proposed without proper consideration, consultation and impact assessments; therefore asks the Commission, if it proposes a new EU-wide regulation in the form of an EU biotech…

   Amendment

   1. Emphasises the growth potential of the European biotechnology and biomanufacturing sector and the need for the EU to remain world leading in these fields; underlines the commitment to the principles of better regulation and lawmaking, simplification and administrative burden reduction; underlines the importance of always protecting the fundamental rights of citizens, workers and businesses; therefore asks the Commission, if a new EU-wide regulation in the form of an EU Biotech Act is proposed, to address concrete gaps and shortcomings in current legislation and implementation, and to present legislation that can be revised, simplified, streamlined, repealed or by which bureaucratic burden…

   Excerpt — full text in the official PDF.
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4. Amendment 4Motion for a resolution · Paragraph 8
   Current text

   8. Calls on the Commission to present a report on the implementation of current legislation in the field of biotechnology and biomanufacturing, including identifying potential gaps and regulatory barriers hampering the growth of the industries applying these technologies and manufacturing processes, including barriers to improving the EU’s self-sufficiency in key feedstocks, raw materials and components; recalls the precautionary principle laid down in Article 191 TFEU; urges the Commission to share with Parliament the preliminary findings of its study on regulatory burden, in this regard, and the potential need to review legislation related to biotechnology and biomanufacturing; calls for a…

   Amendment

   8. Calls on the Commission to present a report on the implementation of current legislation in the field of biotechnology and biomanufacturing, including identifying potential gaps and regulatory barriers hampering the growth of the industries applying these technologies and manufacturing processes, including barriers to improving the EU’s self-sufficiency in key feedstocks, raw materials and components; recalls the precautionary principle in Article 191 TFEU; stresses, however, that an approach disproportionately focused on environmental impact, without taking into account economic and social factors, has already caused harm in other industrial sectors; calls on the Commission to carry out…

   Excerpt — full text in the official PDF.
   official amendment document ↗
5. Amendment 5Motion for a resolution · Paragraph 26 a (new)
   Amendment

   26a. Calls on the Commission to ensure that the proposal on biotechnology is in line with principles such as the respect for life and the protection of human dignity, and to guarantee that all efforts in the fields of innovation and regulatory simplification remain compatible with the highest standards of human dignity and public health; stresses that any restrictive measure adopted by a Member State on bioethical grounds – whether concerning the use of genetic engineering, synthetic biology or the manipulation of sensitive biological material – must not be regarded as an obstacle to the integration of the internal market or to industrial development, but rather as the legitimate expression…

   Excerpt — full text in the official PDF.
   official amendment document ↗