Archive for the ‘European Union’ Category

Baltic nations to restrict entry of Russians, hindering access to EU – Reuters

Register now for FREE unlimited access to Reuters.comRegister

VILNIUS, Sept 7 (Reuters) - European Union members Lithuania, Latvia and Estonia have agreed to restrict the entry of Russian citizens travelling from Russia and Belarus, their foreign ministers said on Wednesday.

The three Baltic nations expect the entry ban to be in place by the middle of September, after it gets formal approval from the national governments, Latvian Foreign Minister Edgars Rinkevics said.

"In the last couple of weeks and months, the border crossing by Russian citizens holding Schengen visas have dramatically increased. This is becoming a public security issue, this is also an issue of a moral and political nature," he told a press conference in Lithuania.

Register now for FREE unlimited access to Reuters.comRegister

The countries will turn back all Russian citizens with visas to enter the EU's Schengen open border area. Exceptions will be made for humanitarian and family reasons, lorry drivers, diplomats.

Direct flights between Russia and the EU were cancelled after Russia invaded Ukraine in February, leaving few options for Russians to travel into the union.

The scheme would be the first of its kind in the European Union. Estonia has had a softer ban in place since Aug. 18, barring the entry only of Russians holding Schengen visas issued by Estonian authorities.

Finland, which also borders Russia, is not joining the ban due to legal uncertainty over whether it can refuse Russian nationals with Schengen visas issued by other European nations, Finnish Foreign Minister Pekka Haavisto told the briefing.

"Can you actually cancel the whole Schengen principles? This is, at the moment, still unclear," he said.

Register now for FREE unlimited access to Reuters.comRegister

Reporting by Andrius Sytas; editing by William Maclean and Bernadette Baum

Our Standards: The Thomson Reuters Trust Principles.

Read more from the original source:
Baltic nations to restrict entry of Russians, hindering access to EU - Reuters

The EU Carbon Border Adjustment Mechanism: Why it should matter to Asian exporters – JD Supra

In 2021, the European Union introduced a Fit for 55 package which was a part of a set of proposals that would assist the European Commission in the delivery of the European Green Deal. The Carbon Border Adjustment Mechanism (CBAM), which is a part of the package, is a proposed border tariff on imports of carbon intensive products into the European Union (EU).

The transitional phase of the implementation of the CBAM will kick in on January 2023 and will cover five industrial sectors, namely: iron and steel; cement; fertilisers; aluminium; and electricity generation. During this time, importers in these sectors will be subjected to the EUs carbon emissions calculations and reporting requirements. This will allow the European Commission to collect accurate CO2-equivalent emissions data from the importers concerned. At this point, importers need not worry about payment of the financial adjustments.

After the transition period ranging from January 2023 to December 2025, the European Commission will evaluate if the ambit of the CBAM should be expanded to include indirect emissions and to products further down the supply chain. Thereafter, from January 2026, EU importers of iron and steel; cement; fertilisers; aluminium; and electricity products will need to obtain the relevant authorisation from a CBAM authority. This authorisation will comprise purchasing carbon certificates which will be priced in correspondence to carbon prices that would have been paid to produce the same in the EU.

While the current EU Emissions Trading System (ETS) covers EU countries, the CBAM will apply to goods produced outside the EU and will indirectly impact supply chains and the manufacturing sector based in Asia that heavily imports goods to the EU. The prices of CBAM certification would be derived from the weekly average auction price of EU ETS allowances, which would be denoted in / tonne of CO2 emitted. Importers will have to register with national authorities where they can buy CBAM certificates, either individually or through a representative. The CBAM would be gradually implemented, meaning that the number of required certificates would be adjusted to reflect any free allowances still allocated under the ETS. The rationale of the law is to address carbon leakage a situation wherein companies move production of goods abroad, to countries with less rigorous emissions policies, predominantly to save costs associated with carbon pricing.

Companies in the identified sectors will have to be mindful that CBAM levies will undeniably increase the cost of exporting to the EU and place them at a relative disadvantage. South Asian and ASEAN economies export greatly to the EU market in the identified sectors, exposing them to the potential CBAM charges. In 2019, of the US$40 billion CBAM-related exports from six South Asian countries, around 14 per cent were sent to the EU. India alone accounted for just above 80 per cent of these exports, while Malaysia accounted for around 15 per cent.

Thus, in order to comply with the new law, affected companies in Asia will have to, at the very least:

Asian economies which export to the EU market will feel the brunt of the CBAM charges. Only a handful of economies in the Asia-Pacific region have a carbon pricing infrastructure in place and even ones that do are significantly lower than the EU or might not cover all the relevant sectors. For example, India has a de-facto carbon tax (levied as coal cess) of around USD 5per tonne, which is applicable only on the production of coal. On the contrary, carbon taxes in the EU range from USD 0.08 to USD 129 per tonne, depending on the country the tax is levied in.

China has ambitious targets for net-zero emissions and adopts one of the worlds most robust emissions trading schemes (a rate-based system) which targets reductions in CO2 emissions per unit of output rather than total CO2 emissions (a mass-based system). The Chinese system covers more than twice the CO2 emissions accounted for under the EU ETS. As of June 2022, Chinese carbon credits cost 8.5% the price of EU ETS credits, with a growth rate of just 10% year-on-year compared to 53% in EU ETS credit prices. This disparity will impact Chinese cement exporters, for instance, who will have to comply with Chinese law as well as the CBAM, and increase in costs anticipating the inclusion of indirect emissions which could potentially target Chinas 57% coal-powered economy.

What this means for stakeholders are rising costs, which are likely to see a year-on-year increase, especially as the carbon footprint of more products are taken into consideration after the initial phase. The cost to calculate, monitor, report, and verify emissions will be on the exporter.

1. CBAM compliance-related measures including but not limited to regulatory changes, calculation and reporting of carbon emissions, and perhaps offsetting will have to be done once the CBAM becomes operational, if companies want to continue exporting to the EU.

Whist the CBAM will be borne by the importer, market practices in the sustainability sector show that the cost for carbon compliance often gets shifted further down to counterparties by back-to-back contracts. This will add to the exporters accounting and operational costs as there will be an imminent need to plan for supply chain management and carbon accounting.

Importers and exporters alike should be mindful of other ancillary issues such as customs declarations and the origin of goods. As it stands, the customs authorities have the obligation to ensure that each importer also known as a customs declarant has been previously registered with the central CBAM authority. In addition to this, the recommendation clarifies that non-preferential rules of origin as per the Union Customs Code shall apply. In theory, this means that goods with a production line encompassing multiple countries will be deemed to originate from the country wherein the last material manufacturing was undergone. This could potentially shift the cost of compliance on manufacturers and exporters based in Asia. Compliance might also become part of the exporters contractual obligations, based on which the importer will comply with the CBAM in the EU.

2. International trade law, carbon finance, and on-going government negotiations

The Paris Agreement is the key driver behind the CBAM, and was negotiated and adopted by 196 countries at the United Nations COP 21 meeting in Paris in December 2015, and entered into force in November 2016. Jurisprudentially and historically (under the common but differentiated responsibility principle), developing countries have maintained that since industrialised nations such as the EU created the problem of global warming through their historic emissions, developing nations should not have to support the cost of mitigating impacts of climate change. In this way, the CBAM may conflict with the Paris Agreement which is based on nationally determined contributions, and by extension individual countries goals on emissions reductions. The CBAM, through its charges, is making developing countries (through their export markets) align with the EU, failing which they will bear extra charges on their exports to the EU. It is important, therefore, to follow international negotiations on the application of the CBAM to developing countries, which will ultimately impact the private sector.

3. Domestic regulations on carbon pricing, taxation, and subsidies

It is crucial to note that some Governments may intend to subsidise the impact of the CBAM on exporters by internal budgeting policies, while others may have contrasting budget policies. Further, compliance under domestic law as well as CBAM may be tricky considering different methods of calculating emissions, harmonising laws, as well as financing offsets.

The CBAM and carbon pricing in Asia in general as well, are fast-developing areas. We are closely monitoring this space to be able to assist our clients in not only compliance with carbon pricing mechanisms but also in helping them avoid legal risk in all aspects of carbon emissions and offsets management.

Dentons Rodyk thanks and acknowledges Pulara Somachandra for her contributions to this article.

More here:
The EU Carbon Border Adjustment Mechanism: Why it should matter to Asian exporters - JD Supra

Scaling up the EU’s response to soaring hunger in West Africa – EU Humanitarian Aid

In West Africa, hunger has reached a sad new record. For the 3rd consecutive year, the Sahel and Lake Chad regions are facing food and nutrition crises of exceptional proportions, affecting up to 38.3 million people.

The multiple conflicts devastating the region have driven millions from their homes and pushed food insecurity as populations abandon their homes to escape violent attacks, leaving vital crops and herds.

The crisis is worsening, also due to the global rise in food prices sparked by COVID-19 restrictions on trade.

As the United Nations reminded the world last April, the war in Ukraine, in all its dimensions, is producing alarming cascading effects on a world economy already battered by COVID-19 and climate change, with particularly dramatic impacts on developing countries.

Therefore, the European Union pledged 554 million on 6 April to increase food security in the Sahel and Lake Chad countries. This funding will also address the root causes of hunger in Burkina Faso, Cameroon, Chad, Mali, Mauritania, Niger and Nigeria.

Continue reading here:
Scaling up the EU's response to soaring hunger in West Africa - EU Humanitarian Aid

Parliament Committee Chair: EU has shown red card to radical Georgian opposition refusing to join work on EU membership – Agenda.ge

Anri Okhanashvili, the Chair of the Georgian Parliament's Legal Affairs Committee, on Wednesday said domestic radical opposition groups that refused to participate in work for Georgia obtaining the European Union membership candidate status had been shown a red card from the European Unions highest tribune.

Okhanashvili was commenting after Josep Borrell, the EU High Representative for Foreign Affairs and Security Policy, said on Tuesday the process of joining the European Union must be based on the consensus of the whole nation and everyone should work together, not only the government but all political parties.

We have heard from the representatives of the European Union that the European perspective for Georgia is a great achievement within the framework of our close cooperation, Okhanashvili noted.

Also, we have heard assessments that both the Parliamentary majority and the entire opposition spectrum bear equal responsibility [in the implementation of EU conditions]. We have heard calls for everyone to be involved in this process, he added.

Read more from the original source:
Parliament Committee Chair: EU has shown red card to radical Georgian opposition refusing to join work on EU membership - Agenda.ge

Viracta Therapeutics Announces Orphan Drug Designation Granted by the European Commission for Nana-val for the Treatment of Peripheral T-cell Lymphoma…

First orphan drug designation granted for Nana-val by the European Commission; fifth globally

SAN DIEGO, Sept. 7, 2022 /PRNewswire/ -- ViractaTherapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, today announced that the European Commission has granted an orphan drug designation (ODD) to nanatinostat and valganciclovir (Nana-val), the company's all-oral combination product candidate, for the treatment of peripheral T-cell lymphoma (PTCL). This represents Nana-val's first ODD in Europe and fifth globally. The U.S. Food and Drug Administration previously granted Nana-val ODD for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and Epstein-Barr virus-positive (EBV+) diffuse large B-cell lymphoma, not otherwise specified.

"This orphan drug designation acknowledges the high unmet medical need of this patient population as well as the potential of the Nana-val o offer therapeutic benefit to patients with recurrent peripheral T-cell lymphoma," said Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta. "Patients with peripheral T-cell lymphoma have few effective treatment options, particularly those with relapsed/refractory disease. Of note, Epstein-Barr virus is frequently associated with peripheral T-cell lymphoma, and reportedly confers a worse overall survival for patients. Following the conclusion of our Phase 1b/2 study, we are now continuing the evaluation of Nana-val in patients with relapsed/refractory Epstein-Barr virus-positive lymphoma in our global Phase 2 NAVAL-1 trial, which is actively enrolling at sites across Europe, North America and Southeast Asia."

ODD in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the European Medicines Agency (EMA) Committee for Orphan Medical Products (COMP). To qualify for ODD from the European Commission, a product candidate must be intended to treat, prevent, or diagnose a life-threatening or chronically debilitating disease that does not affect more than 5 in 10,000 people across the EU. In addition, there must be sufficient clinical or non-clinical data to suggest the product candidate may produce clinically relevant outcomes, and grounds to indicate it can provide a significant benefit over any currently authorized products. Receiving an orphan drug designation from the European Commission provides companies with certain benefits and incentives including clinical protocol assistance, access to a centralized marketing authorization procedure valid in all EU member states, reduced regulatory fees, and ten years of market exclusivity upon receipt of marketing authorization in the EU. The availability of market exclusivity is intended to encourage the development of medicines for rare diseases by protecting them from competition from similar medicines with similar indications, which cannot be marketed during the exclusivity period.

About NAVAL-1

NAVAL-1 (Nanatinostat in Combination with Valganciclovir) is a global, multicenter, open-label Phase 2 basket trial. The trial, which will include patients with multiple subtypes of relapsed/refractory EBV-positive (EBV+) lymphoma, is designed to evaluate the anti-tumor activity of Nana-val and enroll approximately 140 patients. The primary endpoint of the trial is objective tumor response rate as assessed by an independent review committee. If successful, Viracta believes this trial could potentially support multiple new drug application filings across various EBV+ lymphoma subtypes. The study employs a Simon two-stage design where a limited number of patients are enrolled into each cohort in Stage 1 and, if a pre-specified activity threshold is reached, additional patients will be enrolled in Stage 2. During Stage 2, Viracta anticipates discussing the preliminary results with the FDA and may amend the protocol to include additional patients as necessary to enable registration.

About Nana-val (Nanatinostat and Valganciclovir)

Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies.

About Viracta Therapeutics, Inc.

Viracta is a precision oncology company targeting virus-associated malignancies. Viracta's lead product candidate is an all-oral combination therapy of its proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir (collectively referred to as Nana-val). Nana-val is currently being evaluated in multiple ongoing clinical trials, including a pivotal, global, multicenter, open-label Phase 2 basket trial for the treatment of multiple subtypes of relapsed/refractory Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a multinational Phase 1b/2 trial for the treatment of EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors. Viracta is also pursuing the application of its inducible synthetic lethality approach in other virus-related cancers.

For additional information please visit http://www.viracta.com.

Forward-Looking Statements

This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the details, timeline and expected progress for Viracta's ongoing trials and updates regarding the same; and other statements that are not historical facts. Risks and uncertainties related to Viracta that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to: Viracta's ability to successfully enroll patients in and complete its ongoing and planned clinical trials; Viracta's plans to globally develop and commercialize its product candidates, including all oral combinations of nanatinostat and valganciclovir; the timing of initiation of Viracta's planned clinical trials; the timing of the availability of data from Viracta's clinical trials; previous preclinical and clinical results may not be predictive of future clinical results; the timing of any planned investigational new drug application or new drug application; Viracta's plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Viracta's product candidates; Viracta's ability to manufacture or supplying nanatinostat, valganciclovir and pembrolizumab for clinical testing; Viracta's ability to identify additional products or product candidates with significant commercial potential; developments and projections relating to Viracta's competitors and its industry; the impact of government laws and regulations; Viracta's ability to protect its intellectual property position; and Viracta's estimates regarding future expenses, capital requirements and need for additional financing in the future.

These risks and uncertainties may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Viracta's reports and other documents that Viracta has filed, or will file, with the SEC from time to time and available atwww.sec.gov.

The forward-looking statements included in this communication are made only as of the date hereof. Viracta assumes no obligation and does not intend to update these forward-looking statements, except as required by law or applicable regulation.

Investor Relations Contact:Ashleigh BarretoHead of Investor Relations & Corporate CommunicationsViracta Therapeutics, Inc.[emailprotected]

SOURCE Viracta Therapeutics, Inc.

Go here to read the rest:
Viracta Therapeutics Announces Orphan Drug Designation Granted by the European Commission for Nana-val for the Treatment of Peripheral T-cell Lymphoma...