In the midst of the debate over the co-existence of
traditional and GM crops, the Court of Justice of the European
Union (ECJ) has delivered two very important judgments in the space
of a few days. The first invalidates the French moratorium on GMOs
for not being based on the correct EU legislation. The second rules
that honey containing GMO traces, even unintentionally, cannot be
marketed without prior authorization.
The issue of GMOs approval is still being debated within the
European Union. While the European Parliament and the Council are
negotiating the proposed amendment of Directive
2001/181, which may give Member States the possibility
of prohibiting GMOs already approved at European level, the ECJ is
putting its shoulder to the wheel.
The invalidation of the French moratorium
In a judgement of 8 September 20112, the ECJ
invalidated the French moratorium on genetically modified (GM)
crops, because France did not base its decision on the proper EU
legislation. As a reminder, France adopted between 2007 and 2008 a
series of decrees suspending the sale, use and cultivation of the
GM maize seeds MON 810. Monsanto and other seed companies appealed
to the French Conseil d'Etat (France's highest
administrative jurisdiction) which decided to stay the proceedings
and refer to the ECJ questions regarding the rules governing such
emergency measures. The ECJ ruled that France could not adopt its
decision on the basis of the safeguard clause set down in Directive
2001/18, the product in question being governed by Regulation
1829/20033. Nevertheless, the Court also explained that
the measures could have been adopted under this regulation. The
moratorium will remain in force until the final decision of the
Conseil d'Etat, but France already knows that it must amend its
moratorium very quickly.
This decision illustrates once again France's reluctance
regarding the cultivation of GMOs on its territory. While this
debate seems rather outdated, France may nevertheless find new
grounds for defences as the issue of the co-existence of GM and
traditional crops persists.
Traces of GMOs cannot be marketed without prior
In a judgment dated from 6 September 20114, the ECJ,
ruling on questions referred to it by a German court, found that
honey containing traces of pollen derived from GM maize may only be
marketed following prior authorization, regardless of the fact that
the introduction of the pollen in question was unintentional or
accidental, and irrespective of the proportion of GM material
contained in this honey. This preliminary ruling stems from a
request by a Bavarian beekeeper who produced honey near public land
on which Monsanto had been allowed to grow maize MON 810 for
research purposes. In 2005, following the detection of very small
quantities of MON 810 maize DNA in his honey, he initiated
proceedings against Bavaria and Monsanto, seeking both a
declaration that his honey had been rendered unsuitable for
marketing, and damages caused as a result.
On this occasion, the Court went beyond the traditional question
of GMO labelling, and ruled on the even more sensitive and
restrictive issue of market approval. Based on a very broad
interpretation of the precautionary principle5, the
Court has sent a strong signal by implicitly recognizing the
severity of accidental contamination.
This decision is undoubtedly likely to entail serious
consequences, not only giving ammunition to GM crops detractors,
but also affecting imports of honey or other agricultural products
from countries that have authorized the cultivation of GMOs on
1. Directive 2001/18/EC of the European Parliament and of
the Council of 12 March 2001 on the deliberate release into the
environment of genetically modified organisms, OJ 2001, L
2. Monsanto SAS v. Ministre de l'agriculture et
de la pêche, C-58/10 to C-68/10
3. Regulation (EC) N° 1829/2003 of the European
Parliament and of the Council of 22 September 2003 on
genetically modified food and feed, OJ 2003, L 268/1. The
regulation allows the adoption of safeguard measures by a Member
State when he officially informed the European Commission that they
were necessary, but which took no action.
4. Karl Heinz Bablok e.a. v. Freistaat Bayern,
5. On the interpretation of the precautionary principle,
see recent judgement of the ECJ from 22 December 2010 Gowan
Comércio Internacional e Serviços Lda v. Ministero
della Salute, C-77/09, para. 82, where the Court found that
"it must be acknowledged that the Commission has a
wide discretion when it adopts risk management measures [...]. That
procedure entails political choices on its part and complex
assessments. The legality of a measure adopted in that area can be
affected only if the measure is manifestly
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On 27 July 2015, the Minister for Social Affairs and Public Health, Maggie De Block ("the Minister"), and the pharmaceutical sector umbrella organisations pharma.be and FeBelGen entered into a "Pact for the Future"...
In recent years, Turkey made major developments in the pharmaceutical industry. Considering the Association of Research-Based Pharmaceutical Companies' (AIFD) "Ranking of Countries in Pharmaceutical Market" research in 2013, Turkey was in the 18th place and expected to be in the 16th by the end of 2018.
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marketing authorization without submitting information about tests
and clinical trials, if a data exclusivity period does not exist,
in certain circumstances.
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