Paper on the Horizon Europe

POSITION PAPER

 

“HORIZON EUROPE” REGULATION

2018/0224 COD

  • 1- BUDGET AND FIELDS OF RESEARCH
  • 2- RIGHT TO SCIENCE (UN)
  • 3- EVIDENCE-BASED DECISION-MAKING AND DEMOCRACY
  • 4- OPEN ACCESS
  • 5- ELIGIBLE ACTIONS AND GENOME EDITING
  • 6- RARE DISEASES
  • 7- MEDICAL RESEARCH ON CONTROLLED PSYCHOACTIVE SUBSTANCES
  • 8- AWARD CRITERIA AND EVALUATION

1- FIELDS OF RESEARCH COVERED BY HORIZON EUROPE

Science for Democracy supports the proposal to increase the budget of Horizon Europe from 94,1 to 120 bln euros[1]. An increase in budget should also serve the purpose of extending the fields of research supported by the programme. In particular, fields such as the study of the societal impact of artificial intelligence and its future regulation, research for medical purposes on controlled psychoactive substances, genome editing and regenerative medicine[8], should be added to those already funded.

2- RIGHT TO SCIENCE AND FREEDOM OF RESEARCH (UN)

The recitals of the Horizon Europe Regulation should include explicit reference to Article 27 of the Universal Declaration of Human Rights[3], and Article 15 of the International Covenant on Economic Social and Cultural Rights[4], as concerns the right to the enjoyment of the benefits of scientific progress and the freedom of scientific research, underscoring a positive obligation for the EU institutions to implement measures that guarantee such fundamental human rights. In March 2019, the UN Committee on Economic, Social and Cultural Rights will issue a “general comment[5] on the right to enjoy the benefits of scientific progress and its applications concerning the relationship between science and economic, social and cultural rights, which would provide specific guidelines to further clarify States’ obligations concerning that right.

3- OPEN ACCESS

Access to publications is the key to sharing and acquiring scientific knowledge. The verification of research data is the main parameter to evaluate the performance of scientists, as well as for other scientists to take original work further. Thus, the definition of Open Science should not refrain from also encompassing the principle of full – not fair – Open Access to publications. Access to research data should also be granted as a general rule, without reference to specific criteria, such as Intellectual Property[6].

4- EVIDENCE-BASED DECISION-MAKING AND DEMOCRACY

The affirmation of the Right to Science, open access and the adoption of evidence-based decisions are key factors to foster human development, promote the rule of law and reinforce democratic values. This is especially the case for research concerning the regulation of the societal impact of innovation technologies, such as those applied to the exploitation of artificial intelligence, regenerative medicine and democratic processes (i.e. online consultations, voting, cyberattacks). Science for Democracy welcomes the inclusion of a cluster Inclusive and secure society[7], supports an increase in the allocation of the resources to this cluster as well as the balancing of the funds dedicated to inclusiveness and to security.

5- ELIGIBLE ACTIONS AND GENOME EDITING

Research on human embryos and genome editing are amongst the most promising techniques for treating diseases. Horizon Europe should not exclude them from funding a priori. Specific criteria must be developed and applied so as to preserve research techniques that can enhance scientific progress in the treatment of rare and serious diseases. Article 14 of the Horizon Europe proposal should exclude activities intended to modify the genetic heritage of human beings, which could make such changes inheritable, only when they are carried out for non-therapeutic purposes. In fact, treatment for serious and rare diseases should be inheritable. At the same time funding should be secured for the most promising types of Regenerative medicine, that is medicine that develops methods to regrow, repair or replace damaged or diseased cells, organs or tissues, including the generation and use of therapeutic stem cells, tissue engineering and the production of artificial organs. Similarly, funding should be allowed when directed to activities intended to create and let grow human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer within 14 days, and excluded beyond this timeline[8]. Lastly, funding should continue for all those research and open field trials carried out with the mutagenesis techniques for plants, also known as CRISPR-Cas9, that The European Court of Justice in case number C-528/16[9] ruled should be considered genetically modified organisms (GMOs) and therefore be controlled under the cumbersome regulation stemming from the 2001/18[10] directive on GMOs.

6- RARE DISEASES

In the European Union, a disease is defined as rare when it affects fewer than 1 in 2,000 people. There are more than 6000 rare diseases, on the whole, rare diseases may affect 30 million EU citizens.[11] Some 80% of rare diseases are of genetic origin, and are often chronic and life-threatening. The small number of patients often does not allow to scientifically validate the results of the research work; the scarce number of published articles[12] weakens the attention and interest of the research community. Funding should be made available to strengthen and optimize international partnerships and best practices between the academic world and the private sector to obtain new diagnostic and therapeutic possibilities.

7- MEDICAL RESEARCH ON CONTROLLED PSYCHOACTIVE SUBSTANCES

Recent developments in Europe, the United States, Canada and Israel concerning research for therapeutic purposes on some of the plants and substances listed in the four schedules of the Single UN Convention on Narcotic Drugs[13] should be funded. Since 2000, several EU Member States have allowed the prescription of cannabis-based products for a variety of ailments and the Netherlands, the UK, Italy and Germany have started production[14] of THC and CBD rich products. Additional research and some clinical trials are necessary to expand the therapeutic uses of cannabis. At the same time, more studies are recommended along the lines of what Universities and not-for-profit entities have done in the United Kingdom and the United States, with research on MDMA, Psilocybin, DMT, LSD, Ayahuasca, Ketamine and Ibogaine.[15]

8- AWARD CRITERIA AND EVALUATION

Award criteria for Horizon Europe grants should include the evaluation of the outcomes of research activity carried out under previous EU grants by the proposing entities.[16]

SCIENCE FOR DEMOCRACY

Science for Democracy is an organization that promotes the Rule of Law through the affirmation of the Right to Science, the adoption of evidence-based decisions and the promotion of public debates to foster human development. It aims to consolidate democracy as the sole institutional framework that can advance the Right to Science globally. Issues central to the activities of Science for Democracy are the environment and it various ecosystems, human freedom, health and quality of life. Science for Democracy reaches out to the UN Committee for Economic, Social and Cultural Rights as well as other organizations and individuals to engage them in view of the full adoption of the Right to Science by the UN Council on Human Rights in spring of 2019.

Science for Democracy calls upon European institutions, the Members of the European Parliament and the Member States of the EU to account for the Right to Science in the 9th Framework Program for Research and Innovation of the European Union (2021 – 2027), advocating for the increase of resources, the funding of cutting-edge research, and the establishment of an independent and transparent process of evaluation of the innovation and policy impacts of the projects funded. Anyone can join Science for Democracy at www.sciencefordemocracy.org/want.


[1] Art. 8, para 1.

[2] E.g. in Annex I, point 2, (a) And Annex I, point 2 (d).

[3] UDHR, Art. 27

  • Everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits.

[4]ICESCR, Art. 15

  • 1) The States Parties to the present Covenant recognize the right of everyone:
    • (a) To take part in cultural life;
    • (b) To enjoy the benefits of scientific progress and its applications;
    • (c) To benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.
  • (2) The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for the conservation, the development and the diffusion of science and culture.
  • (3) The States Parties to the present Covenant undertake to respect the freedom indispensable for scientific research and creative activity.
  • (4) The States Parties to the present Covenant recognize the benefits to be derived from the encouragement and development of international contacts and co-operation in the scientific and cultural fields.

[5] https://www.ohchr.org/EN/HRBodies/CESCR/Pages/Discussion2018.aspx

[6] Recit. 5; Art. 2 para 1 point 4; Art. 10 para 1; Art. 35 para. 3

[7] Art. 8, para. 2 (b) (2), Annex I point (2) (d).

[8] Text of Art. 14 should read as follows:

  • The following fields of research shall not be financed:
    • (a) activities aiming at human cloning for reproductive purposes;
    • (b) activities intended to modify for non-therapeutic purposes the genetic heritage of human beings which could make such changes heritable;
    • (c) activities intended to create and let grow for more than 14 days human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer.

[9] http://curia.europa.eu/juris/documents.jsf?num=C-528/16

[10] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32001L0018

[11] https://www.eurordis.org/about-rare-diseases

[12] https://www.blackswanfoundation.ch/en/orphan-diseases/research/

[13] https://www.unodc.org/pdf/convention_1961_en.pdf

[14] http://www.emcdda.europa.eu/system/files/publications/4135/TD0217210ENN.pdf_en/

[15] For more information: www.maps.org,http://iceers.org/, https://www.imperial.ac.uk/department-of-medicine/research/brain-sciences/psychiatry/psychedelics/

[16] Text of Art. 25 should read as follows:

  • A proposal shall be evaluated on the basis of the following award criteria:
    • (a)excellence;
    • (b)impact;
    • (c)quality and efficiency of the implementation;
    • (d)the evaluation of previous projects carried out through EU funding