Letter to President of European Commision

From: Luis de Miguel Ortega

- Association of Consumers Scabelum ACUS

To: European Commission

- President Mrs. Ursula Von der Leyen

- Vice President Ms. Věra Jourová Values ​​and Transparency

- Commissioner Mrs. Stella Kyriakides Health and Food Safety

European Commission / Secretary General

B - 1049 Brussels / BELGIUM

Mr. Luis de Miguel Ortega, as Attorney and in the name and representation of the associations indicated above, appears in a timely manner and respectfully SAYS:

FIRST:

That the associations mentioned in this writing, watch over the interests of consumers, especially their health rights and are concerned about the consequences that any reduction in guarantees for human health and the environment may have for the citizens they represent.

Proposing the release and use of genetically modified organisms without guaranteeing the safety of the environment and citizens, seems a crazy idea when not directly terrifying in a context of biological risk that may not only not obtain the adequate response, but may also further aggravate the situation.

The precautionary principle is established to avoid unnecessary risks and has been a doctrinal constant over the years, and in this sense it should be remembered that the seriousness of a situation, by itself, cannot be a reason for a reduction in guarantees and caution as proposed by the Commission.

It is also proposed in a confusing way, without explaining the true object of such modification, which is none other than experimentation with vaccines resulting from genetic engineering, as an experiment for use in the population, without guaranteeing safety -without causing harm-, efficacy - achieving a concrete and measurable objective- and efficiency -at a reasonable cost-.

Throughout the health crisis, there has been a lack of data transparency and an obsession to conduct experiments on human beings, avoid possible responses and treatments, and insist on a vaccine for which there is no prior experience or guarantee.

Real and effective treatments such as artemisia, hydroxychloroquine, chlorine dioxide or vitamin C in high doses, have been banned, reviled, censored and even persecuted, pretending that the objective of the institutions and states was not life, the health and safety of its citizens, but a strange business that we fail to understand.

This institutional behavior, together with the evident collusion with philanthropic-looking pharmaceutical research, production and distribution entities, not only affects the freedom of the market but also the essential rights of citizens and consumers who are left out of the slightest decision.

SECOND:

That this part has studied in detail the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL relating to the performance of clinical trials and the supply of medicinal products for human use that contain genetically modified organisms or are composed of these organisms, intended to treat or prevent coronavirus disease (Text with EEA relevance).

That said modification affects the following Directives that we have studied:

Directive 2009/41 / CE, relative to the contained use of genetically modified microorganisms.

Directive 2001/18 / CE, on the deliberate release into the environment of genetically modified organisms.

Directive 2001/20 / CE, on clinical trials (Directive 2001/18 / CE and Directive 2009/41 / CE).

Directive 2001/83 / EC (Article 83 of Regulation (EC) No. 726/2004).

REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 16, 2014 on clinical trials of medicinal products for human use, and by which Directive 2001/20 / EC is repealed (Text relevant to the purposes of the EEA )

THIRD:

What we have studied in detail:

“ Coordinated EU action to fight the COVID-19 pandemic and its consequences. European Parliament resolution of 17 April 2020 on coordinated action by the Union to combat the COVID - 19 pandemic and its consequences (2020/2616 (RSP)). "

" COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, TO THE EUROPEAN COUNCIL, THE COUNCIL, THE ECONOMIC AND SOCIAL COMMITTEE AND TO THE COMMITTEE OF THE REGIONS The time for Europe to repair the damage and prepare the future for the next generation {SWD (2020) 98 final}"

" European Parliament resolution on the European Union's public health strategy after COVID-19 (2020/2691 (RSP))"

FIFTH:

Having regard to the TFEU, the Commission's Internal Regulations [C (2000) 3614], the CODE OF GOOD ADMINISTRATIVE CONDUCT FOR THE STAFF OF THE EUROPEAN COMMISSION IN THEIR RELATIONS WITH THE PUBLIC, the Statute of the Court of Justice of the European Union ( 1-5-2019) and the Rules of Procedure of the Court of Justice (1-1-2020), we understand that there are reasons to appear before that commission.

SIXTH:

That the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL regarding the performance of clinical trials and the supply of medicinal products for human use that contain genetically modified organisms or are composed of these organisms, intended to treat or prevent coronavirus disease, affects:

1) DIRECTIVE 2011/83 / EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of October 25, 2011 on consumer rights, amending Council Directive 93/13 / EEC and Directive 1999/44 / EC of the European Parliament and of the Council and Directive 85/577 / EEC of the Council and Directive 97/7 / EC of the European Parliament and of the Council (Text with EEA relevance) are repealed.

2) DIRECTIVE 2004/35 / CE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 21, 2004 on environmental liability in relation to the prevention and repair of environmental damage.

3) The TFEU, in its articles:

Article 11 (ex Article 6 TEC) The requirements of environmental protection must be integrated into the definition and implementation of Union policies and actions, in particular with a view to promoting sustainable development.

Article 12 (ex Article 153 (2) TEC) When defining and implementing other Union policies and actions, consumer protection requirements shall be taken into account.

Article 15 (ex Article 255 TEC) 1. In order to promote good governance and to guarantee the participation of civil society, the institutions, bodies and agencies of the Union shall act with the greatest possible respect for the principle of openness.

3. Every citizen of the Union, as well as every natural or legal person who resides or has its registered office in a Member State, shall have the right to access the documents of the institutions, bodies and agencies of the Union, whatever their support. , in accordance with the principles and conditions to be established in accordance with this section.

Article 101 (former Article 81 TEC) 1. All agreements between companies, decisions of associations of companies and concerted practices that may affect trade between Member States and that have as their object or purpose shall be prohibited. The effect of preventing, restricting or distorting the game of competition within the internal market.

Article 102 (former Article 82 TEC) It shall be incompatible with the internal market and, insofar as it may affect trade between Member States, the abusive exploitation, by one or more companies, of a dominant position in the internal market or a substantial part of it.

Article 107 (former Article 87 TEC) 1. Unless the Treaties provide otherwise, the aid granted by the States or through State funds shall be incompatible with the internal market, insofar as they affect trade between Member States. in any way, that distort or threaten to distort competition, favoring certain companies or productions.

Article 191 (ex Article 174 TEC) 1. Union policy in the field of the environment shall contribute to achieving the following objectives: - the conservation, protection and improvement of the quality of the environment.

- the protection of people's health,

- the prudent and rational use of natural resources, - the promotion of measures at international level to deal with regional or global environmental problems. and in particular to fight against climate change.

2. Union policy in the field of the environment shall aim to achieve a high level of protection, bearing in mind the diversity of situations existing in the different regions of the Union. It will be based on the principles of precaution and preventive action, on the principle of correcting attacks on the environment, preferably at the source itself, and on the principle that the polluter pays. In this context, the harmonization measures necessary to meet environmental protection requirements will include, where appropriate, a safeguard clause authorizing Member States to adopt, for non-economic environmental reasons, provisional measures subject to a Union control procedure.

3. In drawing up its policy in the area of ​​the environment, the Union shall take into account:

- the scientific and technical data available,

- environmental conditions in the various regions.

- the benefits and burdens that may result from action or lack of action,

- the economic and social development of the Union as a whole and the balanced development of its regions.

4. Within the framework of their respective competences, the Union and the Member States shall cooperate with third countries and competent international organizations. The modalities of the Union's cooperation may be the subject of agreements between the latter and interested third parties. The preceding paragraph shall be understood without prejudice to the competence of the member states to negotiate in international institutions and to conclude international agreements.

4) It also affects the rights included in the Charter of Fundamental Rights of the EU (2000 / C 364/01)

CHAPTER I on dignity, arts 1, 2 and 3

CHAPTER III on equality, arts. 24, 25 and 26

CHAPTER IV on solidarity, arts. 35, 37 and 38

CHAPTER V on citizenship, arts. 41 and 42

SEVENTH:

The Court of Justice of the European Union shall control the legality of legislative acts, of acts of the Council, of the Commission and of the European Central Bank that are not recommendations or opinions, and of acts of the European Parliament and of the European Council intended to produce legal effects against third parties. It will also control the legality of the acts of the organs or agencies of the Union intended to produce legal effects against third parties.

Any natural or legal person may file an appeal, under the conditions set forth in the first and second paragraphs, against the acts of which it is the recipient or that affect it directly and individually and against the regulatory acts that affect it directly and that do not include measures of execution.

The appeals provided for in this article must be filed within a period of two months from, depending on the case, of the publication of the act, of its notification to the appellant or, in the absence thereof, from the day the appellant had knowledge of the same.

In the event that, in violation of the Treaties, the European Parliament, the European Council, the Council, the Commission or the European Central Bank abstain from acting, the Member States and the other institutions of the Union may appeal to the Court of Justice of the European Union in order to declare such violation. This article shall apply, under the same conditions, to the organs and agencies of the Union that refrain from making a pronouncement.

Any natural or legal person may appeal a complaint to the Court, under the conditions indicated in the preceding paragraphs, because one of the institutions, or one of the organs or agencies of the Union, has not directed an act other than a recommendation or an opinion.

Based on all the above, the signatory associations request:

1) Have associations by persons in the procedure of the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL relative to the performance of clinical trials and the supply of medicines for human use that contain genetically modified organisms or are composed of these organisms, intended to treat or prevent coronavirus disease.

2) These associations are considered an interested party and their legitimacy and direct interest are recognized.

3) The file or, where appropriate, all the information related to said modification that is legitimately accessible to interested persons is transferred to us.

4) It is considered announced that if this claim is not answered within the deadline, a claim will be filed with the Court of Justice of the EU, as established in the provisions that regulate access to said jurisdiction. However, the European Commission requires acknowledgment of receipt stating the corresponding deadlines and resources.

In Burgos on July 25, 2020