Following a review under the recommendation on the gradual lifting of the temporary restrictions on non-essential travel into the EU, the Council updated the list of countries for which travel restrictions should be lifted. As stipulated in the Council recommendation, this list will continue to be reviewed regularly and, as the case may be, updated.
Based on the criteria and conditions set out in the recommendation, as from 8 August member states should gradually lift the travel restrictions at the external borders for residents of the following third countries:
Australia
Canada
Georgia
Japan
New Zealand
Rwanda
South Korea
Thailand
Tunisia
Uruguay
China, subject to confirmation of reciprocity
Residents of Andorra, Monaco, San Marino and the Vatican should be considered as EU residents for the purpose of this recommendation.
The criteria to determine the third countries for which the current travel restriction should be lifted cover in particular the epidemiological situation and containment measures, including physical distancing, as well as economic and social considerations. They are applied cumulatively.
Regarding the epidemiological situation, third countries listed should meet the following criteria, in particular:
number of new COVID-19 cases over the last 14 days and per 100 000 inhabitants close to or below the EU average (as it stood on 15 June 2020)
stable or decreasing trend of new cases over this period in comparison to the previous 14 days
overall response to COVID-19 taking into account available information, including on aspects such as testing, surveillance, contact tracing, containment, treatment and reporting, as well as the reliability of the information and, if needed, the total average score for International Health Regulations (IHR). Information provided by EU delegations on these aspects should also be taken into account.
Reciprocity should also be taken into account regularly and on a case-by-case basis.
For countries where travel restrictions continue to apply, the following categories of people should be exempted from the restrictions:
EU citizens and their family members
long-term EU residents and their family members
travellers with an essential function or need, as listed in the Recommendation.
Schengen associated countries (Iceland, Lichtenstein, Norway, Switzerland) also take part in this recommendation.
The Council recommendation is not a legally binding instrument. The authorities of the member states remain responsible for implementing the content of the recommendation. They may, in full transparency, lift only progressively travel restrictions towards countries listed.
A Member State should not decide to lift the travel restrictions for non-listed third countries before this has been decided in a coordinated manner.
This list of third countries should continue to be reviewed regularly and may be further updated by the Council, as the case may be, after close consultations with the Commission and the relevant EU agencies and services following an overall assessment based on the criteria above.
Travel restrictions may be totally or partially lifted or reintroduced for a specific third country already listed according to changes in some of the conditions and, as a consequence, in the assessment of the epidemiological situation. If the situation in a listed third country worsens quickly, rapid decision-making should be applied.
Background
On 16 March 2020, the Commission adopted a communication recommending a temporary restriction of all non-essential travel from third countries into the EU for one month. EU heads of state or government agreed to implement this restriction on 17 March. The travel restriction was extended for a further month respectively on 8 April 2020 and 8 May 2020.
On 11 June the Commission adopted a communication recommending the further extension of the restriction until 30 June 2020 and setting out an approach for a gradual lifting of the restriction on non-essential travel into the EU as of 1 July 2020.
On 30 June the Council adopted a recommendation on the gradual lifting of the temporary restrictions on non-essential travel into the EU, including an initial list of countries for which member states should start lifting the travel restrictions at the external borders. This list was updated on 16 July and 30 July.
A Spanish consumers association Atty Luis de Miguel Ortega, with a coalition of other associations, has written the President of the European Commission requesting urgent response and adjustment to the law in different health issues related to the current situation of pandemic, saying that:
This institutional behavior, together with the evident collusion with philanthropic-looking pharmaceutical research, production and distribution entities, not only affects the freedom of the market but also the essential rights of citizens and consumers who are left out of the slightest decision.
At the end of the letter (which can be found below the article) request Von der Leyen the following.
1) Have associations by persons in the procedure of the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL relative to the performance of clinical trials and the supply of medicines for human use that contain genetically modified organisms or are composed of these organisms, intended to treat or prevent coronavirus disease.
2) These associations are considered an interested party and their legitimacy and direct interest are recognized.
3) The file or, where appropriate, all the information related to said modification that is legitimately accessible to interested persons is transferred to us.
4) It is considered announced that if this claim is not answered within the deadline, a claim will be filed with the Court of Justice of the EU, as established in the provisions that regulate access to said jurisdiction. However, the European Commission requires acknowledgment of receipt stating the corresponding deadlines and resources.
HERE YOU MAY FAIND THE FULL LETTER
To: European Commission
– President Mrs. Ursula Von der Leyen
– Vice President Ms. Věra Jourová Values and Transparency
– Commissioner Mrs. Stella Kyriakides Health and Food Safety
European Commission / Secretary General
B – 1049 Brussels / BELGIUM
Mr. Luis de Miguel Ortega, as Attorney and in the name and representation of the associations indicated above [Association SCABELUM of Consumers], appears in a timely manner and respectfully SAYS:
FIRST:
That the associations mentioned in this writing, watch over the interests of consumers, especially their health rights and are concerned about the consequences that any reduction in guarantees for human health and the environment may have for the citizens they represent.
Proposing the release and use of genetically modified organisms without guaranteeing the safety of the environment and citizens, seems a crazy idea when not directly terrifying in a context of biological risk that may not only not obtain the adequate response, but may also further aggravate the situation.
The precautionary principle is established to avoid unnecessary risks and has been a doctrinal constant over the years, and in this sense it should be remembered that the seriousness of a situation, by itself, cannot be a reason for a reduction in guarantees and caution as proposed by the Commission.
It is also proposed in a confusing way, without explaining the true object of such modification, which is none other than experimentation with vaccines resulting from genetic engineering, as an experiment for use in the population, without guaranteeing safety -without causing harm-, efficacy – achieving a concrete and measurable objective- and efficiency -at a reasonable cost-.
Throughout the health crisis, there has been a lack of data transparency and an obsession to conduct experiments on human beings, avoid possible responses and treatments, and insist on a vaccine for which there is no prior experience or guarantee.
Real and effective treatments such as artemisia, hydroxychloroquine, chlorine dioxide or vitamin C in high doses, have been banned, reviled, censored and even persecuted, pretending that the objective of the institutions and states was not life, the health and safety of its citizens, but a strange business that we fail to understand.
This institutional behavior, together with the evident collusion with philanthropic-looking pharmaceutical research, production and distribution entities, not only affects the freedom of the market but also the essential rights of citizens and consumers who are left out of the slightest decision.
SECOND:
That this part has studied in detail the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL relating to the performance of clinical trials and the supply of medicinal products for human use that contain genetically modified organisms or are composed of these organisms, intended to treat or prevent coronavirus disease (Text with EEA relevance).
That said modification affects the following Directives that we have studied:
Directive 2009/41 / CE, relative to the contained use of genetically modified microorganisms.
Directive 2001/18 / CE, on the deliberate release into the environment of genetically modified organisms.
Directive 2001/20 / CE, on clinical trials (Directive 2001/18 / CE and Directive 2009/41 / CE).
REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 16, 2014 on clinical trials of medicinal products for human use, and by which Directive 2001/20 / EC is repealed (Text relevant to the purposes of the EEA )
THIRD:
What we have studied in detail:
“ Coordinated EU action to fight the COVID-19 pandemic and its consequences. European Parliament resolution of 17 April 2020 on coordinated action by the Union to combat the COVID – 19 pandemic and its consequences (2020/2616 (RSP)). “
” COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, TO THE EUROPEAN COUNCIL, THE COUNCIL, THE ECONOMIC AND SOCIAL COMMITTEE AND TO THE COMMITTEE OF THE REGIONS The time for Europe to repair the damage and prepare the future for the next generation {SWD (2020) 98 final}”
” European Parliament resolution on the European Union’s public health strategy after COVID-19 (2020/2691 (RSP))”
FIFTH:
Having regard to the TFEU, the Commission’s Internal Regulations [C (2000) 3614], the CODE OF GOOD ADMINISTRATIVE CONDUCT FOR THE STAFF OF THE EUROPEAN COMMISSION IN THEIR RELATIONS WITH THE PUBLIC, the Statute of the Court of Justice of the European Union ( 1-5-2019) and the Rules of Procedure of the Court of Justice (1-1-2020), we understand that there are reasons to appear before that commission.
SIXTH:
That the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL regarding the performance of clinical trials and the supply of medicinal products for human use that contain genetically modified organisms or are composed of these organisms, intended to treat or prevent coronavirus disease, affects:
1) DIRECTIVE 2011/83 / EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of October 25, 2011 on consumer rights, amending Council Directive 93/13 / EEC and Directive 1999/44 / EC of the European Parliament and of the Council and Directive 85/577 / EEC of the Council and Directive 97/7 / EC of the European Parliament and of the Council (Text with EEA relevance) are repealed.
2) DIRECTIVE 2004/35 / CE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 21, 2004 on environmental liability in relation to the prevention and repair of environmental damage.
3) The TFEU, in its articles:
Article 11 (ex Article 6 TEC) The requirements of environmental protection must be integrated into the definition and implementation of Union policies and actions, in particular with a view to promoting sustainable development.
Article 12 (ex Article 153 (2) TEC) When defining and implementing other Union policies and actions, consumer protection requirements shall be taken into account.
Article 15 (ex Article 255 TEC) 1. In order to promote good governance and to guarantee the participation of civil society, the institutions, bodies and agencies of the Union shall act with the greatest possible respect for the principle of openness.
3. Every citizen of the Union, as well as every natural or legal person who resides or has its registered office in a Member State, shall have the right to access the documents of the institutions, bodies and agencies of the Union, whatever their support. , in accordance with the principles and conditions to be established in accordance with this section.
Article 101 (former Article 81 TEC) 1. All agreements between companies, decisions of associations of companies and concerted practices that may affect trade between Member States and that have as their object or purpose shall be prohibited. The effect of preventing, restricting or distorting the game of competition within the internal market.
Article 102 (former Article 82 TEC) It shall be incompatible with the internal market and, insofar as it may affect trade between Member States, the abusive exploitation, by one or more companies, of a dominant position in the internal market or a substantial part of it.
Article 107 (former Article 87 TEC) 1. Unless the Treaties provide otherwise, the aid granted by the States or through State funds shall be incompatible with the internal market, insofar as they affect trade between Member States. in any way, that distort or threaten to distort competition, favoring certain companies or productions.
Article 191 (ex Article 174 TEC) 1. Union policy in the field of the environment shall contribute to achieving the following objectives: – the conservation, protection and improvement of the quality of the environment.
– the protection of people’s health,
– the prudent and rational use of natural resources, – the promotion of measures at international level to deal with regional or global environmental problems. and in particular to fight against climate change.
2. Union policy in the field of the environment shall aim to achieve a high level of protection, bearing in mind the diversity of situations existing in the different regions of the Union. It will be based on the principles of precaution and preventive action, on the principle of correcting attacks on the environment, preferably at the source itself, and on the principle that the polluter pays. In this context, the harmonization measures necessary to meet environmental protection requirements will include, where appropriate, a safeguard clause authorizing Member States to adopt, for non-economic environmental reasons, provisional measures subject to a Union control procedure.
3. In drawing up its policy in the area of the environment, the Union shall take into account:
– the scientific and technical data available,
– environmental conditions in the various regions.
– the benefits and burdens that may result from action or lack of action,
– the economic and social development of the Union as a whole and the balanced development of its regions.
4. Within the framework of their respective competences, the Union and the Member States shall cooperate with third countries and competent international organizations. The modalities of the Union’s cooperation may be the subject of agreements between the latter and interested third parties. The preceding paragraph shall be understood without prejudice to the competence of the member states to negotiate in international institutions and to conclude international agreements.
4) It also affects the rights included in the Charter of Fundamental Rights of the EU (2000 / C 364/01)
CHAPTER I on dignity, arts 1, 2 and 3
CHAPTER III on equality, arts. 24, 25 and 26
CHAPTER IV on solidarity, arts. 35, 37 and 38
CHAPTER V on citizenship, arts. 41 and 42
SEVENTH:
The Court of Justice of the European Union shall control the legality of legislative acts, of acts of the Council, of the Commission and of the European Central Bank that are not recommendations or opinions, and of acts of the European Parliament and of the European Council intended to produce legal effects against third parties. It will also control the legality of the acts of the organs or agencies of the Union intended to produce legal effects against third parties.
Any natural or legal person may file an appeal, under the conditions set forth in the first and second paragraphs, against the acts of which it is the recipient or that affect it directly and individually and against the regulatory acts that affect it directly and that do not include measures of execution.
The appeals provided for in this article must be filed within a period of two months from, depending on the case, of the publication of the act, of its notification to the appellant or, in the absence thereof, from the day the appellant had knowledge of the same.
In the event that, in violation of the Treaties, the European Parliament, the European Council, the Council, the Commission or the European Central Bank abstain from acting, the Member States and the other institutions of the Union may appeal to the Court of Justice of the European Union in order to declare such violation. This article shall apply, under the same conditions, to the organs and agencies of the Union that refrain from making a pronouncement.
Any natural or legal person may appeal a complaint to the Court, under the conditions indicated in the preceding paragraphs, because one of the institutions, or one of the organs or agencies of the Union, has not directed an act other than a recommendation or an opinion.
Based on all the above, the signatory associations request:
1) Have associations by persons in the procedure of the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL relative to the performance of clinical trials and the supply of medicines for human use that contain genetically modified organisms or are composed of these organisms, intended to treat or prevent coronavirus disease.
2) These associations are considered an interested party and their legitimacy and direct interest are recognized.
3) The file or, where appropriate, all the information related to said modification that is legitimately accessible to interested persons is transferred to us.
4) It is considered announced that if this claim is not answered within the deadline, a claim will be filed with the Court of Justice of the EU, as established in the provisions that regulate access to said jurisdiction. However, the European Commission requires acknowledgment of receipt stating the corresponding deadlines and resources.
His Holiness the Dalai Lama reinvigorates call for world peace on 75th Anniversary of the Atomic Bombings of Hiroshima and Nagasaki
By Bureau Reporter His Holiness the Dalai Lama and fellow Nobel Laureates paying their respects at Hiroshima Memorial Park in Hiroshima, Japan on November 14, 2010. Photo by Taikan Usui
In his statement on the occasion of the 75th anniversary of the atomic bombings of Hiroshima and Nagasaki, Tibetan spiritual leader and peace icon, His Holiness the Dalai Lama urged governments, organizations and individuals to “rededicate themselves to making the achievement of peace the centrepiece of our lives”.
Japan on Thursday remembered the victims of the bombings on Hiroshima and Nagasaki, the world’s first atomic bomb attack.
“Despite many great developments that also took place, the 20th century was an era of violence in which some 200 million people were killed, including the horrific use of nuclear weapons,” His Holiness said. “Now, in our increasingly interdependent world, we have a chance to make this a more peaceful century.”
Reiterating his call for global peace and demilitarisation, His Holiness said: “When conflicts arise they should be settled through dialogue, not the use of force. We need to eliminate the threat of nuclear weapons, with the ultimate aim of a demilitarized world. War means killing. Violence leads to counter violence. We need to put an end to combat and the production of weapons and construct a more peaceful world.”
“We human beings have created many of the problems in today’s world. As long as we have strong negative emotions and we view our fellow beings in terms of ‘us’ and ‘them’, there will be a tendency to try to destroy them. We must recognise the oneness of humanity, and understand that we will not achieve peace merely through prayer; we need to take action.”
Left to right: Siblings, Brothers Eldor and Sanjarbek Saburov
On August 6, 2020, a Turkmen court sentenced Brothers Eldor and Sanjarbek Saburov to two years in prison for their conscientious objection to military service. The siblings are 21 and 25 years old, respectively. The court refused the brothers’ request to appeal. This is the second time both were convicted for their neutrality.
In 2016, Brother Sanjarbek Saburov respectfully refused to be drafted into the army. Subsequently, he was convicted and sentenced to two years of probation.
The following year, Sanjarbek’s younger brother, Eldor, also refused to participate in military service. He was sentenced to two years of correctional labor with 20 percent of his wages garnished by the State.
According to Turkmen law, conscientious objectors can be criminally charged a second time if they continue to refuse military service. In April 2020, the military recruiting office again summoned the brothers to enlist. Both brothers refused to be drafted. They were criminally prosecuted, which resulted in their imprisonment.
Beyond the emotional toll, imprisonment will cause acute hardship for the brothers’ parents. Their father suffers from chronic back pain, which impairs his ability to work. His sons support the family by growing cotton. Now that they have been imprisoned, their parents will no longer have the financial support they need. Instead, the parents will now have to care for their sons’ needs in prison.
Turkmenistan does not offer alternative civilian service. Consequently, young brothers who refuse military service on the grounds of conscientious objection face one to four years in prison. Including the Saburov brothers, there are ten young Witnesses in prison in Turkmenistan for their neutrality.
We know Jehovah will bless our young brothers in Turkmenistan for their courageous stand. May each of them recall Jehovah’s promise to King Asa: “You, be strong and do not become discouraged, for your activity will be rewarded.”
Global cooperation – Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO) was addressing the Aspen Security Forum, which brings together top-level present and former government officials from the United States.
The Americas remain the current epicentre of the COVID-19 pandemic.
“For all our differences, we are one human race sharing the same planet and our security is interdependent – no country will be safe, until we’re all safe”, he told the virtual meeting.
“I urge all leaders to choose the path of cooperation and act now to end this pandemic! It’s not just the smart choice, it’s the right choice and it’s the only choice we have.”
Tedros said the pandemic has “stress tested” the global political, economic, cultural and social infrastructure, pushing national health systems everywhere, to their limits.
“The world spends billions every year preparing for potential terrorist attacks but we’ve learned lessons the hard way that unless we invest in pandemic preparedness and the climate crisis, we leave ourselves open to enormous harm”, he said.
As no country can fight the virus alone, Tedros said “our best way forward is to stick with science, solutions and solidarity, and together we can overcome this pandemic.”
Against “vaccine nationalism”
During a question-and-answer session moderated by US network TV news host, Lester Holt, the WHO chief was asked about ensuring fair distribution of a COVID-19 vaccine when one is developed.
Tedros warned against “vaccine nationalism” in a globalized world.
In April, WHO and partners launched the ACT Accelerator to speed up development of vaccines and medicines against the disease, and to ensure that they will be available to people everywhere.
“But to make it happen, especially fair distribution, there should be a global consensus to make a vaccine, any product, a global public product. And this is a political choice, a political commitment, and we want political leaders to decide on this,” he said.
“What we’re saying is sharing vaccines, or sharing other tools, actually helps the world to recover together, and the economic recovery can be faster and the damage from COVID-19 could be less.”
The supplies were transported on behalf of the Pacific Islands Forum, the region’s premier political and economic policy organization.
With commercial air services greatly reduced due to airport closures, and other measures to prevent further spread of the disease, the 18-member bloc has established a platform to facilitate the timely and rapid movement of medical and humanitarian assistance, known as the Pacific Humanitarian Pathway on COVID-19.
“The humanitarian air service flights are a welcome demonstration that the Pacific Humanitarian Pathway on COVID-19 is doing what leaders intended – protecting citizens and supporting health systems”, said Dame Meg Taylor, Pacific Islands Forum Secretary General.
The Pacific region is comprised of more than 20 countries and territories scattered across an area that represents roughly 15 per cent of the earth’s surface.
Therefore, air and sea transport “is nothing short of a lifeline”, according to Jo Pilgrim, Director of WFP’s Pacific Multi-Country Office, which is located in Fiji.
Impact of COVID-19
Although border closures have helped curb the COVID-19 threat, she said impacts have been significant, particularly as the region relies on tourism revenue.
“It’s also affected international supply chains, especially for air cargo, and this makes it very difficult for Pacific governments and international aid organizations to import goods, especially medical equipment like the personal protective equipment that you need to protect our health workers”, Ms. Pilgrim told UN News.
“Even shipping routes across the Pacific, which are major avenues for the importation of food and fuel, for example, have been affected. Even though they are still running, the services are reduced, and the costs are increasing.”
WFP support to nations
Unlike other WFP operations, the Pacific Office does not work on food aid distribution or food assistance. Instead, it supports governments with emergency preparedness in a region that is highly susceptible to cyclones and other extreme weather events.
During the pandemic, staff have been assisting national authorities in three areas: establishing COVID-19 call centres and tele-health initiatives, conducting remote surveys on food security at the household level, and in logistics.
“A good example for logistics is that with the shut-down of the aviation sector affecting the ability of governments and aid organizations to import goods, we have established the Pacific humanitarian air service which will deliver cargo to those countries where there are no viable commercial options available for the importation of freight by air”, said Ms. Pilgrim.
Filling the gap
The Pacific humanitarian air service will transport medical items, medicines, and equipment on behalf of UN agencies such as UNICEF and the World Health Organization (WHO), as well as the International Federation of the Red Cross.
Flights will also deliver supplies on behalf of countries, coordinated through the Pacific Islands Forum Secretariat and the Pacific Humanitarian Pathway for COVID-19.
“Normally, humanitarian air services only move cargo on behalf of humanitarian organizations”, Ms. Pilgrim explained. “But in this particular case in the Pacific, because of the unprecedented circumstances we find ourselves in, where no one can get anything on a plane, we’re also moving medical cargo for the governments.”
Ms. Pilgrim expressed hope that commercial flights will be back in the air soon.
“We don’t want to do anything that would contradict this or that would disincentivize the aviation sector commercially”, she said, “so all the flights that we will operate will be limited as much as possible to those sectors without commercial options.”
The Pacific humanitarian air service is currently funded by Australia and the United States, and the hope is that other donors will step up.
“WFP is a voluntary-funded organization and we rely completely on donations from governments and the private sector, so we can keep flying for as long as we’ve got funds coming in,” said Ms. Pilgrim. “And hopefully we will have enough support from the donor community to allow us to fill the gap in the aviation sector until it’s restored and our services are no longer required.”
Spain: Biotech innovation – the EIB provides €20 million in financing to Sanifit to develop treatments for vascular calcification
The EU bank will support Palma-based Sanifit in its work to develop cutting-edge solutions in biomedical research.
The venture debt operation is supported by the Investment Plan for Europe.
The European Investment Bank (EIB) is set to support the development of new treatments for progressive vascular calcification, an area of significant unmet medical need where there are currently no approved treatments. To this end, the EU bank will provide a €20 million loan to Spanish biopharmaceutical company Sanifit, which is developing novel treatments in two disease indications linked to calcification.
The EIB is advancing funds for this research, development and innovation (RDI) project by way of a venture debt operation with Investment Plan for Europe support, a financing instrument used by the EU bank to assist leading companies in innovative sectors. Since it was launched by the EIB under the Juncker Plan in 2016, this initiative has granted over €2 billion in financing for projects in areas such as robotics, artificial intelligence and biomedicine.
The EIB will provide Sanifit with long-term finance to drive the development of treatments for progressive vascular calcification disorders. The Company, founded as a spin-off out of the University of the Balearic Islands, has developed SNF472, a selective and potent inhibitor of hydroxyapatite (HAP) crystallisation, the final common pathway that leads to vascular calcification.
SNF472 is currently being investigated in a Phase 3 study for the treatment of calciphylaxis, a devastating rare disease where small blood vessels in skin and fat tissue are blocked due to severe calcification, leading to the death of approximately 55% of patients within the first year of diagnosis. A Phase 3 trial in a second indication, peripheral arterial disease, a major driver of morbidity and death in end-stage kidney disease patients, will launch in 2021.
EIB Vice-President Emma Navarro, responsible for the Bank’s operations in Spain, highlighted the “positive impact of this operation on strengthening the competitiveness of the European biomedical industry, a sector requiring large-scale investment and tailored financing solutions. We are delighted to help a leading Spanish company to develop new medical treatments for vascular calcification that will have clear benefits for human health and wellbeing. This agreement underscores the EIB’s commitment to supporting European innovation, which is now more vital than ever to promoting economic recovery and job creation.”
Dr Joan Perelló, Chief Executive Officer of Sanifit, commented: “The support of the EIB represents a significant endorsement of our technology and its potential to help patients suffering from debilitating conditions related to progressive vascular calcification. This is an extremely exciting time for Sanifit as we progress SNF472 through the clinic, and this further investment will be invaluable as we gather the late stage data required for approval, and to deliver treatment options to patients in need.”
Sanifit is a clinical-stage biopharmaceutical company focused on treatments for vascular calcification disorders. The company is a spin-off from the University of the Balearic Islands and has offices in Spain and the U.S. The company’s lead asset, SNF472, has successfully completed a Phase 2 proof of concept study in calciphylaxis and showed a significant reduction in progression of coronary calcification in a Phase 2b study among hemodialysis patients. A Phase 3 pivotal study in calciphylaxis is currently underway and a Phase 3 trial in Peripheral Arterial Disease in End-Stage Kidney Disease patients will launch in 2021. Sanifit has raised approximately $130M, including a 2019 Series D round of $61.8M (€55.2M) in mid-2019. For more information please visit www.sanifit.com
EIB awards €30 million loan to EryDel for development of novel RBC treatment of rare diseases.
EryDel’s treatment platform under development for use in treating rare childhood diseases such as Ataxia Telangiectasia (AT).
Financing supported under the European Fund for Strategic Investments, the main component of the European Commission’s Investment Plan for Europe.
The European Investment Bank (EIB) and Italian biotech company EryDel SpA have signed a contract to provide a loan of €30 million to EryDel. This late-stage biotech company aims to develop and commercialise therapies based on its proprietary RBC technology for the treatment of rare diseases. The EU bank’s loan is backed by a guarantee from the European Fund for Strategic Investments (EFSI), the main pillar of the Investment Plan for Europe under which the EIB and the European Commission are working together as strategic partners, with the EIB’s financing operations boosting the competitiveness of the European economy.
EryDel’s proprietary platform technology is an easy-to-use, fast and automatic bedside procedure for encapsulating small and large molecules including therapeutic enzymes in patients’ own red blood cells. The cells are immediately re-infused into patients, providing prolonged half-life in circulation, reduced immunogenicity, better tolerability and predictable vascular distribution. EryDel’s most advanced product is being developed to treat AT, a rare neurodegenerative childhood disease that causes severe disability. EryDel’s platform RBC technology will be applied to treat other rare diseases as well. The financing will support ongoing R&D by the company and its network of partners, which encompasses research institutes, clinical centres and patient associations.
EIB Vice-President Dario Scannapieco commented: “The fact that EryDel is developing therapies for very rare diseases is all the more reason for us to be proud to support this initiative. With the backing of the EFSI, the EIB is happy to finance EryDel’s development of their autologous RBC encapsulation therapy to treat very serious childhood diseases. As the bank of the European Union, we have to ensure that new innovative EU-based companies continue to have access to finance, so that they can bring their technologies to market to help improve people’s lives.”
European Commissioner for the Economy, Paolo Gentiloni, said: “The Investment Plan for Europe has a very strong track record in identifying and supporting innovative technology companies. With the financing of the Italian company EryDel and its pioneering RBC technology, we will help push the boundaries of what is possible in the treatment of rare diseases to the benefit of patients in Europe and across the world.”
EryDel CEO Luca Benatti said: “We’re delighted to receive this financing from the EIB, which supports our vision of becoming a fully integrated company that can bring innovative therapies to patients. The EIB clearly recognises the unmet medical need for effective therapies for rare diseases and the potential to help patients in Europe and around the world, and supports our belief that in the future there will be effective therapies developed by EryDel for a wide range of rare diseases. The funds will be used for planned expenditures for research and development and capital expenditure activities. Now that we have completed enrolment for our Phase 3 clinical trial ATTeST, the largest clinical study ever conducted in Ataxia Telangiectasia, the support and collaboration we are receiving from the EIB is significant.”
EryDel CCO Ronan Gannon said: “We’re honoured to have the EIB as a partner who shares our market view and technology vision and trusts EryDel to play a leading role in the global rare disease market. It also demonstrates that Europe plays an important role in leading-edge innovations.”
EryDel SpA is a global, late-stage biotech company aiming to use its proprietary red blood cell (RBC) technology to develop and commercialise therapies for the treatment of rare diseases. Its most advanced product EryDex is under late-stage development for the treatment of Ataxia Telangiectasia, a rare autosomal recessive disorder for which no therapy is currently available. A completed Phase II trial in AT patients demonstrated statistically significant efficacy of EryDex on both the primary and secondary endpoints. An international multi-centre Phase III pivotal study, ATTeST, is currently being conducted. EryDel has a pipeline of pre-clinical programmes that are working with its proprietary RBC delivery technology in treating other rare diseases, which includes the use of enzyme replacement therapies.
FIEE’s first fund dedicated to energy efficiency is fully invested ahead of schedule, prompting the launch of follow-up fund, which raised €127.5 million at a first close, above initial €100 million target
The Fund, with a target size of €175 million, gets €39.9 million from the EIB, backed by the European Fund for Strategic Investments, the main pillar of the EU’s Investment Plan for Europe
Investment team doubled and first investments being finalized in companies operating in the residential, energy community and HVACR segments
Fondo Italiano per l’Efficienza Energetica SGR (FIEE SGR), the leading Italian fund and one of the largest European funds specializing in energy efficiency for an energy transition, has launched its second fund – the Italian Energy Efficiency Fund II (FIEE II) – with a first close of €127.5 million, above the initial minimum of €100 million, and the objective of reaching the target of €175 million by the end of the year.
FIEE II has raised capital from the European Investment Bank (EIB) and prestigious Italian institutional investors and family offices, which together manage assets worth approximately €2 trillion. In particular, the EIB – one of the world’s most prominent institutional investors in the green economy and energy transition, and already an anchor investor in the first fund (FIEE I) with €25 million – has increased its commitment to nearly €40 million, confirming its role as anchor investor for FIEE II too. The EIB’s investment is supported by the European Fund for Strategic Investments (EFSI). An important contributor to FIEE II acting as an anchor investor with a commitment of €30 million – doubling the investment made in FIEE I – is also Aviva, led by Alberto Vacca, Italy’s Chief Business & Investment Officer. With 320 years of history and over 33 million clients worldwide, Aviva is one of the world’s largest insurance companies and has properly integrated ESG considerations into its investment decisions.
FIEE II starts with significant support not only from the EIB but also from other FIEE I’s investors, which have responded enthusiastically to the fundraising by subscribing over 90% of first close’s commitments. Through FIEE II, FIEE SGR will extend its range of action to the rest of the European Union and will be able to invest not only in service companies but also in equipment manufacturers, with a particular focus on smart cities and energy communities, in addition to pursuing selected initiatives in the renewable energy sector.
FIEE SGR is managed by the CEOs Raffaele Mellone, former managing director of Merrill Lynch, and Andrea Marano, a former executive of Enel Green Power, and by the chairman Fulvio Conti, former CEO of Enel and chairman of TIM. The promoters also include Lamse S.p.A. (holding company of Andrea Agnelli and his sister Anna) and Maurizio Cereda (former deputy general manager and director of Mediobanca). The board of directors of the SGR also includes Gianfilippo Mancini, a manager with extensive experience in the energy sector gained in Enel and more recently as CEO of Sorgenia, and Giorgio Catallozzi, an independent director with many years of experience in the energy efficiency sector. The promoters have made a financial commitment of €4 million in FIEE II, replicating the commitment made for FIEE I.
European Investment Bank Vice-President Dario Scannapieco commented: “Italy has a lot to gain from investments in energy efficiency, as well as from the small-scale renewable energy projects that the fund will target. Furthermore, FIEE’s attention to projects in low carbon mobility, smart cities, and digitalization are a signal that this kind of investment is not only needed, but nowadays also makes economic sense.”
Raffaele Mellone commented: “The target market has grown and strengthened considerably over the last 4 years. This growth will be intensified by the European Green New Deal, whose effects will begin to materialise over the next 12 months. We have been in the industry for many years now and we have never seen such excitement and so many investment opportunities. Within a few weeks of the first close of FIEE II we will complete the first transactions in the residential, energy community and HVACR sectors, allocating the first portion of raised capital.”
“We are extremely pleased with the support from our investors and would like to thank them for their renewed confidence in our initiative. The positive results achieved by FIEE I show that energy transition is a long-term, sustainable and profitable trend for investors”, added Andrea Marano. “Our ambition is to continue to be a leading player in this constantly evolving and growing sector, and to this end we have doubled our investment team with professionals who bring 30 years of overall experience in investment and the energy sector in leading European institutions.”
“FIEE SGR represents a successful experience gained through the profitability of its investments in a segment of the real economy characterised by the efficient and sustainable use of energy. We are very pleased with the path we have taken, accompanied by our investors who appreciate not only the positive financial returns but also their anti-cyclical nature and resilience to extreme exogenous events such as the recent Covid-19 pandemic. In the current highly complicated macroeconomic environment, energy transition plays an even more crucial role than it did before.” concluded Fulvio Conti.
FIEE SGR has been supported by Legance for legal matters and Cisternino Desiderio & Partners for tax matters.
Fondo Italiano per l’Efficienza Energetica SGR (FIEE) is the equity fund that in recent years has enabled the implementation of the largest energy efficiency investment programme in Europe, concentrated in Italy. FIEE II continues the positive experience of FIEE I, which in just a few years has invested in companies well positioned in the energy efficiency sector in Italy, becoming a market leader in the residential and public lighting segments. The investments are concentrated in highly strategic sectors for the revival of Italy’s economy and for the sustainable growth of its competitiveness. Like the previous fund, FIEE II will have a duration of 12 years, with a target return of 10-12%, to be achieved also through periodic cash distributions, and with lower risk than traditional private equity. For more information please visit our website www.fieesgr.com
With the southernmost country on the continent, now among the top five of the world’s most affected, WHO underscored that it is critical to strengthen its COVID-19 response.
“At this time, when the COVID-19 epidemic in South Africa is spreading rapidly, it is important that we work together to intensify our fight against the virus”, said Owen Kaluwa, WHO Representative for South Africa.
To help manage the coronavirus outbreak, WHO will be deploying 43 experts from various fields, including seasoned infectious disease epidemiologist and public health expert, David Heymann, who headed the response to the 2003 epidemic of the closely-related viral respiratory disease, SARS.
WHO will be complementing scaled-up national and provincial responses to minimize the spread and impact of COVID-19.
“Our collective efforts are necessary to identify cases, isolate and provide care, follow up contacts and fully implement physical distancing and other key public health measure”, said the WHO official.
WHO will fund the international surge team and South Africa will provide administrative resources. The team will be jointly led by WHO Regional Director for Africa, Matshidiso Moeti, and Executive Director of the agency’s Health Emergencies Programme, Michael Ryan, who will work virtually from Brazzaville, Congo, and Geneva respectively, to support the experts on the ground.
“Dr. Moeti and Dr. Ryan have become familiar and trusted figures in the fight against COVID-19”, said South African Minister of Health, Zweli Mkhize. “They have been supporting and complementing our national efforts and we have had very fruitful and honest discussions with them”.
Before their deployments in the provinces of Eastern Cape, Free State, Gauteng, Kwazulu Natal and Mpumalanga, the delegation completed an initial period of quarantine and testing.
“These provinces have been identified as the ones needing the most urgent support where the first team can make the most impact”, according to General Health Director Sandile Buthelezi.
Tasks ahead
The surge team aims to contribute to national efforts, including in surveillance and streamlining of epidemiological systems.
It intends to improve case management by promoting WHO’s global COVID-19 response guidelines and reduce the burden on hospitals by increasing community buy-in to assure greater compliance with public health measures.
‘Key priority’
WHO’s Regional Office for Africa has made supporting South Africa “a key priority”, according said Dr Moeti, who affirmed that working together “will help flatten the curve and save lives”.
“Our solidarity which spans the globe is a model partnership for an effective response”, she concluded. “United we will defeat COVID-19.”
