ethics by design Archives - European Industrial Pharmacists Group (EIPG)

A new member within EIPG

The European Industrial Pharmacists Group (EIPG) is pleased to announce the Romanian Association (AFFI) as its newest member following the annual General Assembly of EIPG in Rome (20th-21st April 2024). Commenting on the continued growth of EIPG’s membership, EIPG President Read more

The EU Parliament voted its position on the Unitary SPC

by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection

by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

The debate on the “Do No Significant Harm” principle in R&D

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by Giulianna Miglierini

The “Do No Significant Harm” (DNSH) principle is a widely diffused approach aimed to guarantee the respect of ethical limits while dealing with many kinds of activities. It is the case, for example, of the use of big data to conduct behavioural studies, or of health research aimed to be of help to society without hurting anyone. Available frameworks regulating the ethical approach to research usually focus on the protection of participants against unwanted, potentially harmful effects resulting from the study. Examples of such frameworks are the 1964 Declaration of Helsinki and the 1979 Belmont Re-port, which do not mention the protection of other people and of the environment.

The DNSH and the European Green Deal

The introduction of the Do Not Significant Harm principle within the Taxonomy regulation (EU 2020/825) represents the first example of its extensive application aimed to prevent unintended damages to the environment. According to the regulation, beneficiaries of financial support from EU institutions are expected to assess the possible negative climate and environmental impacts of their projects, and to avoid any activity that may negatively impact the sustainability objectives of the European Green Deal.

These include six main areas of attention, i.e. mitigation of and adaptation to climate change, sustainable use and protection of water and marine resources, control and prevention of pollution, the transition to a circular economy, and the protection and restoration of biodiversity and ecosystems.

The inclusion of the DNSH principle in the Taxonomy regulations means that the above-mentioned objectives would apply to any EU funded activity, including framework research programmes such as Horizon Europe.

Many critics arose from this move of the Commission, as it may greatly affect the effective capacity of researchers to plan and realise their activities. As a part of the debate, MEP member Christian Ehler presented in July 2021 a written question to the Commission aimed to clarify how the DNSH aspects of a project would be evaluated and scored during the assessment of the proposals, and the impact they may have on the final outcome of such assessment.

The written answer provided by EU Commissioner Mariya Gabriel stated that “the application of the ‘Do No Significant Harm’ principle in Horizon Europe is voluntary at project level”, and that its inclusion in the project description will have no impact on the assessment of the proposal. According to the Commission, no declaration of projects compliance with the principle is re-quested, and no undue increase of the administrative burden for applicants is present. Instead, the reference made to the DNSH principle would only aim to raise awareness about the environmental risks linked to research activities and encourage the identification and mitigation of potential measures.

A second written question presented in August 2022 asked the Commission to provide further details, i.e. how many applications under Horizon Europe included the DNSH principle in the project description, the percentage of 2021/2022 budget covered by DNSH and the number of evaluations in which the DNSH principle was used in the assessment of the application.

The written answer by Commissioner Gabriel indicated references to the DNSH principle in proposals vary according to its relevance to the specific thematic area and technology readiness levels. Only 2.6% of proposals referred to parts of the programme that make no explicit reference to DNSH considered the principle; this percentage reached 29.6% for applications referred to parts of the programme making explicit reference to it (data 12 August 2022). Commissioner Gabriel also said almost half of the budget of the work programme for 2021-2022 made explicit reference to the DNSH principle, and that all EU actions and policies have to be consistent with the objectives of the Paris Agreement and the Green Deal oath ‘do no harm’.

The ongoing debate

No matter to say, the position of the European Commission to extend the implementation of the DNSH principle across all research activities activated a reach debate within the R&I community. The initial objections by MEPs were based, according to Mr. Ehler, on the possible absence of “democratically legitimised criteria” (read more on Science|Business).

According to a viewpoint article published in Science|Business, the DNSH approach chosen by the Commission would be not the right way to address the issue of environmental sustainability. “Rather, research and innovation policy should be reconfigured to allow researchers to ‘stay with’ the harms they (might) do”, wrote the authors. The alternative to DNSH sees greater attention towards a better understanding of what really constitutes a “harm”. According to the authors, a definition of “significant harm” should be agreed upon between humans, non-humans, and ecosystems experiencing harm, thus avoiding any technocratically and unilaterally handed down definition. They also discuss the appropriateness of the concept of ‘situatedness’ in order to reach a suitable definition of significant harm.

Key to this vision should be the “understanding that there is no universal, objective viewpoint from which one might determine which research is beneficial or harmful, for whom, and to what degree”. To this instance, elements to be considered in the assessment include the time needed for the harm to manifest, its geographical location or the involvement of marginalised actors. Furthermore, the approach adopted by the EU Commission would not be suited to solve the ambiguities. A possible solution would be represented by the “creation of spaces where ambiguous harms can be appropriately engaged”.

The associations representing the academic and scientific world also took a position against the extension of the DNSH principle to all projects under European R&I framework programmes.

The European University Association (EUA), CESAER (representing universities of Science and Technology) and Science Europe (on behalf of major public organisations funding or performing research in the EU) jointly published a statement to ask support to the Parliament as for the approval of amendment 165, focused on feasibility, appropriateness and proportionality of all programmes and activities, in accordance with the relevant sector-specific rules. The associations also underline that the implementation of the DNSH principle should not be counterproductive and weaken the contribution of the R&I community to sustainability and green objectives.

According to EUA, clear guidelines are missing on how the principle should be implemented in practical terms. Furthermore, the broad application of the DNSH principle might especially undermine the possibility to undertake fundamental research activities. As for now, the principle applies only to European Innovation Council projects, and missions and clusters of Pillar II of particular relevance for their environmental outcomes and impacts.

In a position paper of October 2022, CAESAR asked, among others, for an “ethics by design” approach, based on a ethical checklist to be included in the design phase of projects. Briefings with the proposal evaluator and project reviewer should also be improved in order to clarify when the DNSH principle has to be taken into account.

According to Science Europe, the implementation of the principle should not add an additional administrative burden to researchers and increase the complexity of project proposals and evaluations. The association also asks for the broader application of the DNSH principle to be preceded by a thorough assessment of its current implementation in Horizon Europe.