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The Court of Justice of the European Union (CJEU), in itsruling of 7 July 2022given on case C-24/21, confirmed that Member States (and their territorial entities with legislative powers) may restrict or prohibit by law the cultivation of approved crops of Genetically Modified Organisms (GMOs), but recalled that specific conditions must be met, as set forth inDirective 2001/18/EC(on the deliberate release into the environment of genetically modified organisms) andRegulation (EC) No. 1829/2003(on genetically modified food and feed). The Courts ruling is based on the text of Directive 2001/18/EC in force prior to the amendments introduced byDirective (EU) 2015/412, which added a new Article 26b (Transitional Measures), establishing a procedure through which Member States may request that the geographical scope of a GMO notification/application be submitted, or an authorization granted be adjusted to exclude all or part of their territory from cultivation.

The dispute arose from the action of a farmer, Mr. PH, who deliberately violated the lawNo. 5/2011of Friuli Venezia Giulia (an Italian autonomous region), prohibiting the cultivation of the authorized crop of MON810 GMO maize and was therefore fined by local authorities. The purpose of the regional law was to prevent and avoid cross-contamination between different types of crops: GMO, conventional, and organic.

PH filed an opposition against the sanction with the Territorial Court, which halted the proceedings to request a preliminary ruling from the Court of Justice on the correct interpretation of the EU regulatory framework on GMOs.

The Court recalled Article 26-bis(1) of Directive 2001/18/EC, which states,Member States may take appropriate measures to avoid the unintended presence of GMOs in other products.

Therefore, Member States may only adopt preventive measures to avoid the unintended presence of GMOs in other products, thus ensuring that farmers and consumers have a choice between organic, conventional, and GMO production, as pointed out in theCommission Recommendation of 13 July 2010. On the other hand, these measures cannot be justified by the need to protect human health or the environment, since their protection is already achieved by the risk assessment carried out according to Directive 2001/18/EC and Regulation No 1829/2003 (see paragraph 47 of the ruling).

Such measures must be proportionate insofar as they must minimize their restrictive effects to what is necessary to achieve their purpose.

It is therefore up to the national court of Friuli Venezia Giulia to determine whether the regional law complies with the above principles and to analyze the specific conditions of the area affected by such preventive measures, to assess whether they are necessary and proportionate to avoid cross-contamination between GMOs and conventional/biological crops. The local court should base its decision on the actual degree of contamination and the likelihood of further contamination, considering specific geographic factors and the economic consequences (in terms of losses) for producers if a higher degree of contamination occurs. The decision is expected in the coming months, but the tracks are laid and there is no room for prejudices about GMO cultivation: everything must have a reasonable and proven justification.

As already mentioned, Directive (EU) 2015/412 amended Directive 2001/18/EC by introducing a provision [Article 26(b)] facilitating how Member States may exclude all or part of their territory from the cultivation of GMOs, either by requiring such exclusion prior to the granting of authorization or by adopting measures after that moment and, in the latter case, only when special needs are demonstrated (e.g., environmental policy objectives, socio-economic impacts, etc.), provided that the measures are proportionate and reasonable. Thus, whereas the provision cited in the Court ruling under review, which is still in force, only concerns the need to avoid the unintended presence of GMOs, the new article offers a broader range of justifications.

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European Union Court of Justice Weighs In on GMO Crop Ban - The National Law Review

Markets in Crypto Assets Regulation (MiCA)

Markets in Crypto Assets (MiCA) regulation is an agency brought into existence by European Union. The crypto assets which are currently not under the provision by MiFID are going to be brought under regulatory framework in MiCA. The framework at its basic scope doesnt apply to NFTs and other qualifying financial assets under MiFID.

Credits: The Parliament Magzine

The regulation will be implemented across the European Union and it is believed that the permission of national laws is not mandatory for the implementation. This strategy ensures efficient and standardized access to the cutting-edge crypto-asset markets across the single market while also maintaining consumer safety.

The Objectives of MiCA!

Essentially four objectives have been set up by the EU for MiCA to achieve.

European Unions Fears!

As MiCA came into existence, the scope of work for the regulatory body increased rapidly as it has to act as a regulatory body for all the 27 countries which have agreed to be part of European Unions agency.

The major fear that is persistent with the European Union is that, if they will be able to recruit enough employees and work force to efficiently regulate the market and help the crypto industry grow.

The European Banking authority Jose Manuel Campa went on to make the official statement that, the agency is lacking behind in the capacity to regulate the digital assets market, and if the agency fails to recruit the appropriate number of employees with accurate knowledge, then the entire agency will be labelled as a failure.

As 2025 approaches, Campa told the FT, the EBA is concerned about figuring out the mechanics of executing its new powers because it wont know which cryptocurrencies it would regulate.

Campa also acknowledged that there is high demand for crypto talent, but there is a scarcity in supply to satisfy that demand. Logistically speaking, the agency will soon exhaust most of its funds finding the right recruit to regulate the digital asset market.

Writers Analysis:

From a personal point of view, the MiCA is a great step by European Union towards regulating the digital asset industry. But the question to consider now is whether the agency will be able to recruit the right people at the right time or not. If the agency is successful, then the EUs decision will reap huge benefits in the long run. If the agency fails, then all the efforts towards making the agency will go down the drain.

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European Union fears that it wont be able to recruit staff to regulate the market - Techstory

Lithuania will continue to provide expert support to Ukraine on its road to membership of the European Union and will advocate the earliest possible beginning of accession negotiations.

Lithuanian President Gitanas Nauseda said this in a speech in the Verkhovna Rada on Thursday, according to an Ukrinform correspondent.

"We will help Ukraine overcome this difficult path. We will continue to provide expert support and, together with you, we will strive for the earliest possible start of negotiations on membership in the European Union," he said.

According to Nauseda, the experience of his country shows that a fundamental condition for successful European integration is broad political consensus, and it is very important that such a provision is enshrined in the Constitution of Ukraine.

Nauseda visited Kyiv on the Day of Ukrainian Statehood.

On June 23, the heads of state and government of the European Union adopted a decision to grant Ukraine the status of a candidate country for EU membership.

Ukrainian President Volodymyr Zelensky said that despite the war unleashed by Russia, Ukraine will continue to implement the legislation, norms and rules of the European Union, and the Cabinet of Ministers will develop a respective road map to fulfill the requirements for joining the EU.

Photo: Ukrainian President's Office

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Lithuania to support speedy beginning of talks on Ukraine's EU membership - Nauseda - Ukrinform

European Union governments on Tuesday neared an agreement on rationing natural gas this winter to protect against any further supply cuts by Russia as Moscow pursues its invasion of Ukraine.

EU energy ministers deliberated over a draft European law that would require member states to cut demand for natural gas by 15 per cent from August through March.

This would entail voluntary steps to reduce gas consumption and, if they yield insufficient savings, a trigger to impose mandatory moves across the 27-nation bloc.

On Monday, Russian energy giant Gazprom said it would limit supplies to the EU through the Nord Stream 1 pipeline to 20 per cent of capacity, heightening concerns that Russian President Vladimir Putin will use gas trade to challenge the bloc's opposition to the war in Ukraine.

The winter is coming and we don't know how cold it will be, said Czech Industry Minister Jozef Sikela, whose policy portfolio includes energy. But what we know for sure is that Putin will continue to play his dirty games in misusing and blackmailing by gas supplies.

The European Commission, the EU's executive arm, is pressing the ministers to reach an agreement less than a week after rushing out the rationing proposal.

We have to be ready for the possible supply cuts from Russia at any moment, said European Energy Commissioner Kadri Simson. We have to act right now.

Since Russia invaded Ukraine in February and the West protested with economic sanctions, 12 EU countries have faced halts to, or reductions in, Russian gas deliveries.

Although it has agreed to embargo oil and coal from Russia starting later this year, the EU has refrained from imposing sanctions on Russian natural gas because Germany, Italy and some other member states rely heavily on these imports.

The disruptions in Russian energy trade with the EU are stoking inflation that is already at record levels in Europe and threatening to trigger a recession in the bloc just as it was recovering from a pandemic-induced slump.

The energy squeeze is also reviving decades-old political challenges for Europe about policy coordination. While the EU has gained centralised authority over monetary, trade, antitrust and farm policies, national sovereignty over energy matters still largely prevails.

In a sign of this, the European Commission ruffled feathers by planning under the proposed rationing rules to give itself the power to decide on any move from voluntary to mandatory actions.

Any agreement among the ministers may strip away this provision and ensure that a decision on mandatory gas rationing would lie in the hands of EU governments.

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European Union Nears Deal To Ration Gas Amid Russian Cut-Off Fears - Outlook India

LES ULIS, France--(BUSINESS WIRE)--LFB today announced that the European Medicines Agency (EMA) has granted on July 15th a Marketing Authorisation for CEVENFACTA (eptacog beta), as the first new bypassing agent in over 20 years. CEVENFACTA is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:

Denis Delval, LFBs Chairman and Chief Executive Officer, stated: We are very pleased with the approval of CEVENFACTA by the EMA, which provides a new treatment option for haemophilia patients with inhibitors in the European Union. This approval is a validation of our innovative LFB technology and the acknowledgement of LFBs deep commitment to patients.

Dr. Patrick Delavault, MD, LFBs Executive Vice President Scientific, Medical and Regulatory Affairs, stated: We need to keep in mind constantly what a bleeding event, even a single bleeding event, means to a haemophilia patient with inhibitors and to his family. This novel treatment alternative is a significative opportunity to improve patients lives.

LFB has been granted a Marketing Authorisation for SEVENFACT (eptacog beta) in Mexico on June 2nd for the treatment of bleeding episodes in adults and adolescents with haemophilia A or B with inhibitors.

About PERSEPT studies:

The approval of CEVENFACTA was based on data from the phase III clinical trials, PERSEPT 1 and PERSEPT 3.

The PERSEPT 1 Phase III, multicentre, randomised, open-label crossover study of two initial dose regimens (75g/kg and 225g/kg), evaluated 468 bleeding episodes across the full type of severity of bleeding episodes (mild, moderate, and severe), in 27 adolescent and adult haemophilia A and B patients with inhibitors (12-54 years of age). Both dosing regimens met the primary endpoint with 81% and 90% of bleeds controlled at 12 hours with the 75g/kg dose and the 225g/kg dose respectively. By 24 hours, haemostatic efficacy (secondary endpoint) was retained in 96.7% of bleeding episodes treated with the 75 g/kg dose regimen and 99.5% of redundancy bleeding episodes treated with the 225 g/kg dose, without requiring any alternative therapy. The median time to attain haemostatic efficacy was 5.98 hours for the 75 g/kg dosing regimen and 3 hours for the 225 g/kg dosing regimen. A median of 2 injections was needed to treat a bleeding episode with the 75 g/kg and a median of only 1 injection of the 225 g/kg dosing regimen was needed.

The PERSEPT 3 Phase III, multicentre, open-label, single-arm study evaluated the safety and efficacy of CEVENFACTA in haemophilia A or B patients with inhibitors who were scheduled for an elective surgical or other invasive procedure. 12 patients were enrolled in the study, 6 with minor procedures and 6 with major procedures. For major surgical/invasive procedures, treatment was administered at an initial bolus dose of 200 g/kg immediately before the start of the invasive procedure. For a minor elective surgical procedure, an initial bolus dose of 75 g/kg was administered immediately before the start of the procedure. Overall, 81.8% of procedures were reported as successfully treated at 48 hours after the last administration of the product.

No thromboembolic events were reported in these two clinical trials. No Serious Adverse Events (SAEs) were considered as related to the treatment.

Patients should be monitored for any signs of thrombosis, hypersensitivity and neutralising antibodies. The most frequently reported adverse reactions in studies were infusion site discomfort, infusion site haematoma, post-procedural haematoma, infusion related reaction, increased body temperature, dizziness and headache.

About LFB

LFB is a bio-pharmaceutical group that develops, manufactures and markets plasma derived products and recombinant proteins for the treatment of patients with serious and often rare diseases. LFB was founded in 1994 in France and is among the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals with blood-derived therapeutics with the vision to provide treatment options to patients in three major areas: immunology, haemostasis, and intensive care.

LFB currently markets 15 biomedicinal products in more than 30 countries.

Please visit http://www.groupe-lfb.com for further information on LFB.

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LFB Announces the Approval of CEVENFACTA (eptacog beta) in the European Union - Business Wire