GMO vaccines, back on a secret decision in the European Parliament

EXCLUSIVE INTERVIEW: Michèle Rivasi, is a member of the European Parliament since 2009, and a member of Europe Ecologie Les Verts (EELV). She is a specialist in environmental health and public health issues at the European Parliament where she relentlessly leads a fight for transparency and access to data and information, against the lobbies that poison us: agrifood, chemicals, pharmaceutical. She is an associate professor of natural sciences and holds a PhD in science education.   

On July 10th, a law on GMO vaccines was voted on the sly in the European Parliament without real democratic debate in urgency.  This could impact us all, Michèle Rivasi explains.

FS: What exactly happened on July 10? What was decided by the European Parliament?

MR: On July 10, 2020, the European Parliament adopted a proposal from the European Commission aimed at reducing the requirements before the start of clinical trials with medicinal products consisting of or containing GMOs. The text was adopted by a large majority of 505 votes in favour, against 67 and 109 abstentions. Nearly 10% of members of the European Parliament  voted against  it, including almost all French MEPs EELV.

This text is dangerous, as in particular it exempts the manufacturers of these treatments and vaccines based on GMOs from providing the environmental risk assessment study and biosafety before any request for clinical trial and marketing of such drugs requested. This was so far the legislation on GMO.

The Commission specifies that this, only concerns clinical trials, is only valid in the context of the fight against Covid-19 , and as long as it is classified as a pandemic or considered as a public health emergency. However, this proposal for an exemption from GMO legislation for experimental anti-Covid19 GMO drugs is a terrible signal for us, the Greens, and  contrary to the principle of precaution.

Another shocking element, is that this vote took place without any political debate , without giving Members the opportunity to ask questions.

FS How is this possible? How did we get there?

MR: This dispensation took place in ten days. It started with the publication on June 17 by the European Commission of its EU Covid-19 vaccine strategy. Then followed, at the end of June, the information that a proposal for regulation modification - proposed by the European Commission, which has the legislative “power of initiative” - will be submitted to the vote of the Parliament via an emergency procedure.

It was the so-called “ENVI coordinator” MEPs, who represent the voice of the political groups within their respective parliamentary committees, who accepted the proposal for an emergency procedure and validated the rest of the process. Once the agreement of the 3 main Euro-parliamentary political groups has been obtained - the conservative centre-right EPP, the SD socialists, and the RENEW liberals where En Marche sits - the majority is acquired and small groups such as the Greens (68 deputies), far left (GUE, 39 deputies), the far right (ID, 76 deputies) act as extras.

This emergency procedure makes it possible, to avoid the discussion stage and voting in the Environment Committee of the European Parliament and to go directly to plenary session.

We thus bypass a first level of political debate. Then, in plenary, the vote on this emergency resolution also took place without public debate .

Second short circuit. We save time, we do it quickly, we were even asked not to vote on an amendment to avoid additional negotiations which would have lengthened the implementation deadlines. For its part, the Council of Member States voted for the Commission text on July 3. Then, during our plenary session in July, the only one of the summer, therefore the only chance to have the text adopted before September, the text submitted by the European Commission was therefore adopted on Friday July 10 as it is by Parliament, without modification, so as not to delay its application, effective since July 15.

There was clearly an instrumentalization of the Parliament's emergency procedures by the Commission, to avoid a democratic debate on GMO vaccines as it risked the absence of consensus or unanimity and would have raised inconvenient truths , in particular on the experimental nature GMO vaccines and on the numerous exemptions aimed at facilitating their marketing.

Simultaneously, it should also be noted that a parliamentary hearing on the supply of anti-Covid-19 vaccines within the EU was scheduled for July 2. This parliamentary hearing would have taken place before the favourable votes of the Council, then that of the European Parliament. But this debate, also too risky perhaps, was cancelled - for lack of availability of the invited speakers it was said and postponed several times. This hearing will finally take place on September 22, with 3 “pharma” representatives and one NGO representative. Another vaccine debate is scheduled with the European Commission next week, Monday September 7th.

FS: Why did you vote against this exemption?

MR: The first thing to understand is that these GMO anti-Covid-19 vaccines are highly experimental drugs . We almost know nothing about their genetic effects in the medium to long term.

First of all, since 2003 and the SARS surge in Asia, the scientific community has never succeeded in developing a vaccine against the coronaviruses. Then there are several different GMO technologies used to develop the various GMO Covid-19 vaccines under evaluation. Among these GMO technologies, three have never been authorized for medicinal products for human use.

GM vaccines represent a new market for GMO manufacturers, a very promising market where start-ups and unicorns are jostling each other. You should know that a large part of GMO vaccines is derived from gene therapy techniques ...

except that these gene therapies are not mastered and have not been proven.

For the reader it is important to remind that a gene therapy trial carried out using a vector virus - an adenovirus similar to the candidate anti Covid19 vaccine carried by AstraZeneca - led to the appearance of blood cancer in two of the ten bubble babies participating in the supervised trial by professor of immunology Alain Fisher in 2003. Specialists speak of “insertional oncogenicity” to describe this cancer risk induced by genetic manipulation.

We can also add to this that, for sanitary and health emergency reasons, it has been recorded since April 2020 that anti-Covid treatments and vaccines will benefit from accelerated assessment and authorization procedures.

That is to say that decisions will be taken on the basis of incomplete data or by invoking exemptions ...

We weaken the legislation to accelerate and go faster, but instead of doing more research, we are increasing the share of unknowns, uncertainties based on promises from the GMO industry. It's the world upside down.

This “light” trend goes against the precautionary principle.

We can see that in the name of the health crisis, we are deregulating at all costs. The installation of relay antennas is facilitated by exempting companies from declaring their work to the public authorities. Here, in the pharmaceutical sector, the same logic prevails.

Why accelerate? To respond to the health emergency. The same argument was used in 2009 during the H1N1 crisis. This will also and above all allow pharmaceutical groups to benefit from large-scale commercial agreements , developing their stock market value. The first past the goal post will win the jackpot for public procurement! If we are in an emergency, we should be armed with the political courage to freeze stock market prices rather than put ourselves in situations of financial conflicts of interest which influence public decision-making.

More and more of us are contesting this principle of legislative always less, what the lobbies describe as an “administrative burden” for tobacco and plastic, and that we find as of September 2019 for tobacco. GMO vaccines. We establish a form of irresponsibility: no one is responsible for anything. Finally, if we transfer the responsibility to the state, to the public. Which again creates a conflict of interest. Because if things go wrong, the state will have no interest in admitting its wrongs. Rather, we should give ourselves the means to verify, this would be even better, By having more public research and less public-private partnership that allows large companies to benefit from public funds without real compensation.

Then, on GMOs itself, it is also a question of being consistent. We Greens have always been against the presence of GMOs in the food chain. We are very attentive and very sensitive on the issues of dissemination and genetic pollution.

If we do not want to ingest GMOs through our food, it is not so that GMOs can enter us, injected via completely experimental vaccines and authorized in a hurry.

FS: You, along with other MEPs, raise other questions. Which ones? Why do we want to draw our attention now to these provisions?

MR: The first thing is the lack of transparency . The negotiations in progress take place in the greatest opacity. NGOs dealing with public health have drawn the attention of the Green MEPs to the extremely expeditious conditions in which pre-purchase negotiations are conducted. Discussions are conducted in very small committees, behind closed doors, and the conditions for decision-making, governance as they say, raise questions. The sums at stake are enormous,

but the decisions of pre-purchase of drugs or vaccines are taken without control or without democratic or citizen observer. Let’s remember, it is a question of public money.

Still on the topic of transparency we, Greens, demand from the European Commission the most complete transparency of clinical trials carried out or in progress on experimental anti-covid drugs. This is what European regulations demand and which Big Pharma too often refuses to provide. It is impossible that these firms benefit from public funding and criticial sizeable public contracts, that this happens to harming health transparency.

We have had enough opacity and small arrangements between friends. In addition, since we are in exceptional conditions which require exceptional measures, we apply exceptional transparency rules. When the data, methods and results of clinical trials are provided to the European Medicines Agency, the latter must make them available to independent experts. We have seen for the Lancet article scandal how the data can be phony, flawed and manipulative. Even the biggest, the most famous, have let themselves be trapped and causing unfounded public health decisions. You have to be able to do independent audits and checks from raw data from clinical trials. This is the guarantee of an independent evaluation of research work of the influence of pharma lobbies.

Then, it is not by dispensing with producing preliminary impact studies, or by authorizing the marketing of treatments or vaccines with incomplete data, that we will have safe and effective drugs. It is even rather the reverse . Instead of giving ourselves all the means to ensure the efficacy and harmlessness of experimental drugs, we are on the contrary breaking down all safeguards. Only one thing matters: to be as fast as possible, we reduce the procedures and we evaluate with incomplete data. This is not the way to guarantee a high level of protection of public health.

Accelerated, lean, marketing procedures are a demand of the drug industry, not of public health .

This power of influence of the drug industry is also reflected in recent announcements on the legal liability of manufacturers. "The advance purchase agreements concluded with certain laboratories provide that the Member States compensate the manufacturer for certain responsibilities incurred" now indicates the European Commission. The drug companies themselves are using all their weight to guard against possible legal action against adverse effects of their treatments or vaccines.

It is not for the population in these conditions to become guinea pigs for vaccines and experimental drugs presented as “safe” but whose manufacturers do not want to assume the consequences.

Sources of the commission's quote:

https://www.capital.fr/entreprises-marches/vaccins-contre-la-covid-lue-indemnisera-les-laboratoires-en-cas-deffets-secondaires-inattendus-1379072

other links on the issue of liability:

https://uk.reuters.com/article/us-astrazeneca-results-vaccine-liability/astrazeneca-to-be-exempt-from-coronavirus-vaccine-liability-claims-in-most-countries-idUKKCN24V2EN

https://www.reuters.com/article/us-health-coronavirus-eu-vaccines-exclus/exclusive-eu-talks-with-pfizer-sanofi-jj-on-covid-vaccines-hit-snags-sources- idUSKCN24S1YQ

on gene therapy and insertional oncogenicity https: //www.liberation.fr/societe/2003/01/16/bebe-bulle-second-cas-de-le ...