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Ambassador of the European Union on Georgias membership

EU Ambassador to Georgia Pavel Gerchinsky says that the EU wants to give Georgia the opportunity to join, however, Georgia itself decides whether the country wants to be a member of the EU or not.

Whatever decision Georgia makes, we in the European Union respect it. We understand that 89 percent of Georgians support European integration and EU membership. This is a historically high figure, says Gerchinsky.

He hopes that the process of Georgias accession to the European Union will be successfully completed. According to him, this is a long and complex process that all countries have gone through to join the European Union:

I also know that European integration is included in the Georgian constitution. We are here to help you, work with you and make sure the Georgian government has the support it needs to make that dream come true. However, it is now up to the Georgians to move this stone, and I hope that this process will continue and successfully culminate in Georgias membership in the European Union. It will be a long and difficult process. This is the path followed by all the countries that wanted to join the European Union. However, everything is in the hands of the Georgian political elite.

Lets hope there is enough progress on reforms for the 27 member states to take the next step towards Georgias membership in the European Union, a candidate status that Georgia could have achieved in December. However, I repeat, this will depend on the progress that Georgia makes on the path of reforms, he said.

On June 17, 2022, the European Commission prepared a conclusion re granting Georgia, Ukraine and Moldova candidate status for EU membership. As a result, Ukraine and Moldova will receive EU candidate status and will be required to fulfill certain obligations, while Georgia will first be obliged to fulfill the 12-point plan and conditions, and then get a chance to receive the candidate status.

On November 8, 2022, the European Parliamentarians discussed the annual report on the implementation of the Association Agreement between Georgia and the European Union at a meeting of the Foreign Affairs Committee in Brussels. According to the adopted compromise document, Bidzina Ivanishvili is no longer mentioned as an oligarch, however, in the chapter on deoligarchization, his name and surname are indicated and it is written that it is necessary to take, among other things, legislative decisions regarding Ivanishvilis excessive influence.

On February 3 this year, the European Commission published a report on Georgia, Ukraine and Moldovas compliance with EU legislation and assessed Georgias compliance with EU foreign policy as moderately prepared.

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Ambassador of the European Union on Georgia's membership - JAMnews

The European Union has a plan to decarbonize aviation over the coming decades.

The European Union reached a provisional agreement on Tuesday aiming to decarbonize air travel and create a level playing field for sustainable aviation fuels (SAFs).

The ReFuelEU Aviation proposal aims to put Europes air travel industry on a trajectory to meet the E.U.s climate targets for 2030 and 2050. Adina Vlean, the European Commissioner for Transport, called the agreement a turning point for European aviation.

Before becoming law, the agreement must be approved by individual E.U. member countries, but that is viewed as a formality.

Once adopted, the law will require airlines to use fuel that blends sustainable aviation fuels (SAF) with kerosene in progressively larger amounts, beginning at 2% of the total fuel in 2025, rising to 6% by 2030 and to 70% by 2050.

The plan is for the quotas to help spur both the demand for and supply of SAFs, which will in turn bring costs down. Until now, the development of SAFs has been hindered by low supply and prices that are still considerably higher than fossil fuels.

E.U. officials are touting ReFuelEU Aviation as a win-win for both the environment and the economy. Shifting to sustainable aviation fuels will improve our energy security, while reducing reliance on fossil fuel imports, said Vlean. These kinds of measures help make Europe a front-runner in the production of innovative clean fuels, globally. We estimate that the SAF market will create more than 200,000 additional jobs in the EU, mainly in the renewables sector.

Since 2021, the E.U. and U.S. have agreed to achieve net zero carbon emissions by 2050. But their approaches have been different.

In early September 2021, the Biden administration announced a new sustainable aviation fuel goal to increase the production of SAF to at least three billion gallons per year by 2030.

The plan includes an SAF tax credit and the launch of a new SAF Grand Challenge to ramp up domestic production of SAFs with a roadmap devised holistically by an interagency team that includes the departments of energy, transportation and agriculture as well as stakeholders from national labs, universities, non-governmental organizations, and the aviation, agricultural, and energy industries.

On Wednesday, the International Air Transport Association (IATA), the global airline lobby, expressed reservations about the mandate-driven approach outlined in the European plan. Mandates send a signal to producers and the market and risk a huge increase in cost and a license to print money for fuel suppliers, while raising the price of mobility throughout the E.U., said Conrad Clifford, IATA Deputy Director General.

The Inflation Reduction Act in the United States shows the power of significant incentives in driving production, said Clifford. Without similar firepower being deployed in the E.U., the E.U. faces having to import SAF in order to meet its own targets, increasing costs and diminishing the environmental gains.

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'A Turning Point': The European Union Agrees To Decarbonize Air ... - Forbes

The European Union bloc is reportedly negotiating an amended deal withPfizer Inc(NYSE: PFE) andBioNTech SE(NASDAQ: BNTX) for around 70 million COVID-19 vaccine doses, despite the European public prosecutor opening a criminal investigation into their original agreement.

The updated proposal includes a new provision for member states to pay half price, about10,for each canceled dose.

The revised contract would allow the EU to upgrade to newer vaccines tailored to any future COVID-19 variants, the Financial Times reportedcitingpeople close to the matter.

Also Read:FDA Gives Green Signal To Second Omicron-Adapted Booster Shots For People At High Risk From Covid.

The report added that Poland and some other central European countries refuse to sign the amended deal because they do not want to pay for canceled doses.

But if the conditions can be persuaded, a revised deal would highlight the near-monopoly status enjoyed by BioNTech/Pfizer across the bloc.

If [BioNTech/Pfizer] supply around 70mn doses per year for the next few years, thats pretty much the totality of the market, said one person familiar with the negotiations.

A proposed deal for 70 million doses until 2026 threatens to push rivalsModerna Inc(NASDAQ: MRNA),Novavax Inc(NASDAQ: NVAX), andSanofi SA(NASDAQ: SNY) out of the market.

Sanofi and Novavax previously committed to orders with the EU that were much smaller than the numbers announced, people familiar with the matter said.

About 90% of doses delivered have since been unused, with a large proportion being destroyed or will be because either they passed their expiration dates or there was no demand for them.

Price Action:PFE shares are up 0.18% at $38.96 during the premarket session on the last check Monday. BNTX shares are down 2.21% at $111.72.

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This article European Union's Amended COVID-19 Vaccine Deal with Pfizer-BioNTech: Near-Monopoly Status Potential Threat to Rivals originally appeared on Benzinga.com

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European Union's Amended COVID-19 Vaccine Deal with Pfizer-BioNTech: Near-Monopoly Status Potential Threat to Rivals - Yahoo Finance

The European Union (EU) has just published its proposals to revise its general pharmaceutical legislation. One of the objectives of the revision is to reduce the regulatory burden on the pharmaceutical industry when seeking authorisations for new products and to provide a flexible framework to take account of the demands of innovation.

The EU is determined to remain a competitive regulatory jurisdiction compared to, for example, the United States. The proposals aim to streamline and simplify regulatory procedures and to future proof the legislation with a view to accommodating new technologies. The changes are expected to yield cost savings for the European pharmaceutical industry, in particular for small and medium sized enterprises.

After the electronic Common Technical Document (eCTD) submission was established for marketing authorisation applications over the last years, member states are now to be given the option to decide whether the package leaflet will be made available on paper or electronically or both. The European Commission (EC) has reserved a delegated power to make electronic package leaflets compulsory, but is only enabled to use this power starting 6 years and 6 months after the proposed new Directive to replace Directive 2001/83 (Draft Directive) enters into force.

The European Medicines Agency will be able to offer a phased, or rolling, review of data packages for individual modules of marketing authorisation applications. This will apply to medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life threatening or seriously debilitating or serious and chronic condition in the union.

The time scale for the grant of a marketing authorisation will be further accelerated, e.g. the scientific evaluation period before the opinion of the Committee for Medicinal Products for Human Use (CHMP) is reduced from 210 days to 180 days.

The role of the EMA in providing scientific advice is broadened. Undertakings and not for profit entities established in the EU may request scientific advice in parallel with the joint scientific consultation carried out by the Member State Coordination Group on Health Technology Assessment (HTACG). This will help developers of new medicines to ensure that their clinical trial programme generates the necessary evidence both for authorisation as well as for pricing and reimbursement decisions. Parallel scientific advice may also be sought from the expert panels established under the Medical Devices Regulation by applicants for marketing authorisation for medicinal products involving a medical device.

There will be enhanced scientific and regulatory support for priority medicines that, based on preliminary scientific evidence, are likely to address an unmet medical need or provide an exceptional therapeutic advancement.

The sunset clause, which led to medicinal products losing their marketing authorisation if not placed on the market within 3 years of grant, is abolished. Furthermore, marketing authorisations will generally be valid for an unlimited period without the need for renewal after five years.

A single assessment of an active substance master file will be introduced which will result in a certificate. The use of the certificate will be mandatory for subsequent applications concerning the same active substance. This procedure may in future be extended to excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates.

The EMA will reduce the number of its standing committees to two, the Committee for Medicinal Products for Human Use (CHMP), and its safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC). The Committee for Orphan Medicinal Products (COMP), the Committee for Advanced Therapy Medicinal Products (CAT), and the Paediatric Committee (PDCO) will become working parties, which can lend expertise to the CHMP as needed. The effect will be that applicants will only have to deal with one committee, rather than up to five in some cases at present, as they steer their products through the authorisation process.

The representation of patients and health care professionals will be increased at the CHMP and PRAC.

The EC hopes that this simplified structure will free up resources to focus on early scientific support to promising medicines and the repurposing of authorised medicinal products.

The place of adapted clinical trials in providing evidence to support the benefit/risk analysis in relation to new active substances is recognised in the draft legislation. A new concept of a regulatory sandbox is introduced. This is a controlled regulatory assessment framework set up for a limited time for developing or testing innovative or adapted solutions that facilitate the development and authorisation of products that might be regulated as medicinal products. A regulatory sandbox may be set up by the EC where it is not possible to develop a medicinal product in compliance with the existing regulatory requirements because of scientific or regulatory challenges related to characteristics of the product that positively contribute to the quality, safety or efficacy of the medicinal product or category of products or provide a major contribution to the access of patients to treatment.

Health data generated outside of clinical trials, including real world data, will play a role in regulatory decision making in future. The recitals to the proposed Regulation replacing Regulation 726/2004 suggest that the EMA will use data from the European Health Data Space (EHDS) as well as taking advantage of supercomputing, artificial intelligence and big data science.

The Draft Directive establishes three kinds of combination products: integral combinations of medicinal products with medical devices, medicinal products in exclusive use with medical devices and combinations of medicinal products with a product other than a medical device. Referring to integral combinations, Article 117 of the new Medical Devices Regulation (MDR) has already outlined, that the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements according to the MDR. The Draft Directive provides more specific rules for the assessment of integral combinations of a medicinal product with a medical device, clarifying the interplay between the two regimes regulating medicines and medical devices. The benefit-risk balance of the integral combination will be assessed taking account of the suitability of the use of the medicinal product with the medical device.

The new proposals will need to be considered in detail by the Member States and debated and possibly amended by the European Parliament before the final versions of the new Medicines Directive and Regulation come into force. There will be an eighteen-month transitional period meaning that these new measures are not likely to become effective before 2026 or perhaps 2027.

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European Union to streamline medicines regulatory process to ... - JD Supra

"One of the absolutely most important priorities of our presidency in the European Union... will be strengthening cooperation with the United States, strengthening Euro-Atlantic ties," Duda Said. Pawe Supernak/PAP

Andrzej Duda, the Polish president, said on Monday, marking the 19th anniversary of Poland's accession to the European Union, that strengthening cooperation with the United States will be the priority of the Polish presidency in the bloc.

During a joint speech with Prime Minister Mateusz Morawiecki, Duda said that Poland is already preparing to its presidency over the Council of the European Union in the first half of 2025.

"It will be a very important moment. We want to be able to settle in the (European) Union as much as possible in the interest of the Republic of Poland," he said.

According to Duda, Poland's EU presidency will have several priorities, as he agreed with Morawiecki.

"One of the absolutely most important priorities of our presidency in the European Union... will be strengthening cooperation with the United States, strengthening Euro-Atlantic ties," he said, adding that he meant both economic and security cooperation.

"More United States in Europe, more European Union in the United States," he added.

Duda said that he and Morawiecki had informed the President of the United States, Joe Biden, about this priority when he was visiting Warsaw in February.

"Cooperation with the United States is of fundamental importance to us, also for the building of our security," he said citing support for Ukraine, the presence of US troops in Poland and strengthening Nato's eastern flank as examples of US security activities.

As the second priority of the Polish presidency of the Council of the European Union Duda mentioned striving to ensure that Ukraine, together with Moldova, becomes part of the EU.

He added that the countries of the Western Balkans should also be accepted into the bloc.

Another priority of Poland's EU presidency, according to Duda, is participation in the post-war reconstruction of Ukraine.

"We would like the European Union and us in the European Union to carry out this reconstruction of Ukraine. For this we need funds, for this we need not only our cooperation with all our partners in the European Union, but also a good attitude and good functioning of European institutions in this direction," he said.

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Poland's EU presidency to focus on tightening cooperation with US ... - The First News