Posts Tagged Transparency

The innovation principle’s continued journey.

A short update on the innovation principle‘s continued (corporate-sponsored, let’s be frank) journey.

Thank you first of all prof Maria Lee for signalling the UK’s planned introduction of an ‘innovation test’, to be piloted as part of industrial strategy. Its goal is expressed as ‘We will create an outcome-focused, flexible regulatory system that enables innovation to thrive while protecting citizens and the environment.’ Not much more detail is given. Formulated as such, it does nothing that the current EU regulatory model does not already address – its true goal undoubtedly is a post-Brexit libertarian regulatory environment.

Further, Nina Holland observed with eagle eyes the link between Nafta 2.0 (USMCA) and innovation, in particular Article 12-A-4 ‘parties’ “recognize the importance of developing and implementing measures in a manner that achieves their respective level of protection without creating unnecessary economic barriers or impediments to technological innovation’ (like the UK initiative: meaningless for already addressed by current international trade agreements; the real intention actually is deregulation). American industry has been arguing that the US should ‘build on’ the new NAFTA when negotiating with the EU (should TTIP ever be resuscitated).

Geert.

 

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Ghostbusters and the Marshmallow Man. The European Commission covert consultation and study on the innovation principle.

I have reported before on the innovation principle, the industry efforts behind it and the European Commission response to same. I have linked our initial paper as well as media and other reports in an earlier posting. The most comprehensive overview of the genesis of the principle is included here.

One of the comments I made in that earlier post is that Commissioner Moedas has emphasised verbatim that the innovation principle is not binding EU law: ‘“I think we have some misunderstanding here … The Horizon Europe proposal does not in any way establish the innovation principle or incorporate it into EU law. It is referred to in the recitals but it is not something that is [in] the proposal,” he said.

At the end of the original Ghostbusters movie, a giant Marshmallow Man appears as a result of the main ghost’s conjuring up himself as the physical manifestation of the first thought popping up into the mind of the lead characters’ mind (further info here). The road to turning the imagination of the innovation principle into reality is currently equally continuing with no less than a Commission-ordered Consultation Report, from the Centre for European Policy Studies, on the evaluation of the innovation principle: see the Directorate-General’s invitation letter and the questionnaire.

Both documents reached me via a little Berlaymont bird. I have anonymised individuals mentioned in the documents and I have also changed the order of questions in the questionnaire just in case individual copies were drafted to facilitate the coveted ‘confidentiality’ – contents of the questionnaire have stayed the same. The questionnaire is meant for ‘selected stakeholders’ who are instructed not to ‘share, quote or cite it’.

The principle even if it does exist certainly does not do so in EU law – as confirmed by the Commissioner. Yet it is his DG which has instructed CEPS to carry out the study, confidentially: not exactly a driving principle of the Better Regulation Agenda to which the documents purport to answer.

The invite states that ‘the overall aim of this evaluation is to describe the status quo and prepare recommendations for future action in accordance with the better regulation guidelines. These recommendations will serve to apply the Innovation Principle in a way which helps the achievement of EU policy objectives and is consistent with identified stakeholder needs.’

The text pays lip service to the general interest which ‘innovation’ is meant to serve, yet also repeatedly emphasises that existing regulatory hurdles to ‘innovation’ ought to be classified and potentially removed; that the EC may take the necessary steps to initiate this; and nowhere does it question the very existence of the principle.

It is noteworthy in this respect that Horizon Europe, Europe’s next flagship research and development program, refers drastically less to responsibly research and innovation -RRI than did its predecessor. Parliament did not halt references to the innovation principle in its recitals.

I would like to emphasise again that with my co-authors of the paper, I am not an unshakable opponent of the introduction of an innovation principle. Provided the discussion on it is done in the appropriate institutions and at the very least in the public domain. A confidential survey confirms the reactionary character which this principle so far represents on the EU scene.

Geert.

 

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Some data crunching on manufactured nanomaterials.

A short post on manufactured nanomaterials and data. (Readers will be aware that although the blog focuses mostly on litigation, I dabble in regulatory research and practice, too. And that nanotechnology regulation has been a consistent interest of mine).

Thank you Lynn Bergeson and Carla Hutton for flagging the study by EUON on data collection and reporting methodology for manufactured nanomaterials. EUON, the European Union’s Observatory for Nanomaterials, is hosted by ECHA – the EU’s Chemicals Agency. The study’s purpose is made clear on p.15 (only) of the report: the overall context is for the regulators to have an overview of the heterogeneous market for nanomaterials. In order to do so, the study measures the reliability etc of existing reports and studies on the nanomaterials market. It concludes that a Delphi study of the existing research would be required.

For those of you with an interest in information flows and the transparency of data, the implications are clear: part of the exercise of regulating new technologies is to know what is out there; and manufacturers’ data clearly are not making it into the public domain in a transparent and coherent manner. Consider alongside this report, for instance the proposed US EPA rule on transparency in regulator science.

Geert.

 

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Limits to calling upon intellectual property to justify non-disclosure of environmental information – The ECJ in Greenpeace and PAN Europe v Commission (glyphosate)

The ECJ yesterday morning held in an important case with respect to the EU’s transparency regime.

Regulation 1049/2001 constitutes the general regime on access to documents held by EU Institutions. Regulation 1367/2006 implements the Aarhus Convention as far as the EU Institutions are concerned. Directive 91/414 is the plant protection Directive. Under the plant protection Directive, Germany had been the Member State with responsibility to report on the acceptability of approving glyphosate. Greenpeace and Pesticide Action Network Europe had requested access to

–        a copy of the draft assessment report issued by Germany, prior to the first inclusion of glyphosate in Annex I to Directive 91/414;

–        a complete list of all tests submitted by the operators seeking the inclusion of glyphosate in Annex I;

–        the full, complete and original test documents supplied by the operators seeking the inclusion of glyphosate in Annex I, in so far as concerns all long-term toxicity tests, all mutagenicity tests, carcinogenicity tests, neurotoxicity tests and all reproduction studies.

The Commission, upon assist by Germany, granted access to the draft report, with the exception of volume 4 thereof, which the German authorities refused to disclose and which includes the complete list of all tests submitted by the operators seeking the first inclusion of glyphosate in Annex I. Germany was of the opinion that the document at issue contained confidential information relating to the intellectual property rights of the operators which had sought the inclusion of glyphosate in Annex I to Directive 91/414, namely the detailed chemical composition of the active substance produced by each of them, detailed information concerning the process by which each of them produced the substance, information on the impurities, the composition of the finished products and the contractual relations between the various operators which had sought the inclusion of glyphosate.

The ECJ noted the important impact of 1367/2006 on the working of the basic Regulation, Regulation 1049/2001: the first sentence of Article 6(1) of Regulation No 1367/2006 lays down a legal presumption that an overriding public interest in disclosure (relevant for the application of exceptions written into Regulation 1049/2001) exists where the information requested relates to emissions into the environment, except where that information concerns an investigation, in particular one concerning possible infringements of EU law. The Court held that accordingly,  the first sentence of Article 6(1) of Regulation No 1367/2006 requires that if the institution concerned receives an application for access to a document, it must disclose it where the information requested relates to emissions into the environment, even if such disclosure is liable to undermine the protection of the commercial interests of a particular natural or legal person, including that person’s intellectual property, within the meaning of Article 4(2), first indent, of Regulation No 1049/2001. (at 38) The Court rejected any attempt by the EC to soften the impact of Article 6(1) of Regulation 1367/2006: ‘in claris non fit interpretatio’, the provision has to be read on its prima facie meaning. Any other application ‘would amount to disapplying a clear and unconditional provision of a European Union regulation, which is not even claimed to be contrary to a superior rule of law.‘ (at 44 in fine)

The Court subsequently at length considered the meaning of ‘environmental information’ and gave this a wide interpretation.

The case is a good illustration of the complex web of transparency requirements and the consistent approach of the ECJ in favour of disclosure.

Geert.

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Lessons learned from ACTA – European Commission transparency on TTIP

The European Commission (EC) has just published its position papers on a number of key aspects of the TTIP negotiations (the Transatlantic Trade and Investment Partnership with the United States). The move is unprecedented: one does not normally get an insight into the EC’s point of view on core aspects of a crucial international trade negotiation, this early in the proceedings. One must not be naive, of course. Red lines are not given away in the documents. Nevertheless, the EC would seem to have learnt its lessons from the ACTA (Anti-Counterfeiting Trade Agreement) debacle, in which (unfounded, in my view) accusations of backroom deals and intransparency  assisted the European Parliament in scuppering EU ratification of the Agreement.

The sectors covered in the current papers, are Cross-cutting & institutional provisions on regulatory issues; Technical barriers to trade; Sanitary and Phytosanitary measures (i.e. barriers to trade in food and agricultural products); Public Procurement; Raw materials and energy; and Trade and sustainable development.

Geert.

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