Melbourne, Australia: Neuren Pharmaceuticals (ASX: NEU) has received notice from the European Medicines Agency (EMA) of positive opinions for all three Orphan designation applications that were submitted for NNZ-2591 in Phelan-McDermid syndrome, Angelman syndrome and Pitt Hopkins syndrome.

Under the Orphan procedure timetable, the European Commission is scheduled to issue the decisions in January. Orphan designation in the EU enables sponsors to benefit from incentives including free protocol assistance, fee reductions and 10 years of market exclusivity plus two additional years if approved for paediatric use. During that exclusivity period, the EMA and the EU Member States shall not accept another marketing authorisation application for a similar medicinal product in the same therapeutic indication.

Neuren plans to commence Phase 2 trials in patients with each of Phelan-McDermid syndrome, Angelman syndrome and Pitt Hopkins syndrome in 2021 to confirm the potential of NNZ-2591 to address the urgent unmet need in these three serious childhood disorders. Neuren CEO Jon Pilcher commented:

“We are pleased to have received no questions following the EMA review of our compelling pre-clinical results and the rationale for treatment with NNZ2591. We move forward to Phase 2 trials with increased confidence now that we have Orphan designation for all three indications in the two largest markets. We look forward to engaging with both the FDA and the EMA as we strive to develop an effective treatment for patients and families living with these debilitating conditions.”

The Government has denied reports it rejected an offer of visa-free tours by musicians in the European Union, saying it pushed for a ‘more ambitious agreement’ during negotiations.

The UK’s post-Brexit travel rules, which came into force on January 1, do not guarantee visa-free travel for artists and other creatives throughout the EU’s 27 member states.

Industry bodies, including trade group UK Music, have warned that performers who have to secure individual visas for each country they visit may face extra costs.

Citing an EU source close to negotiations, the Independent reported that a ‘standard’ proposal to exempt performers for 90 days was turned down by the UK, prompting anger from some musicians.

The unnamed EU source close to negotiations told the Independent: ‘It is usually in our agreements with third countries, that [work] visas are not required for musicians. We tried to include it, but the UK said no.

The source went on to say that the UK refused to agree because ‘they said they were ending free moment’, adding that it was ‘untrue’ to say they asked for something more ambitious.

Without a bloc-wide agreement for visa-free travel, it will be up to each member state to decide the entry requirements for musicians travelling in their country, an arrangement which campaigners say will lead to added costs and bureaucracy. 

A Government spokesperson described the reports as ‘misleading speculation’.

They said: ‘The UK pushed for a more ambitious agreement with the EU on the temporary movement of business travellers, which would have covered musicians and others, but our proposals were rejected by the EU.’

Radiohead frontman Thom Yorke, composer Nitin Sawhney and Charlatans singer Tim Burgess were among those who voiced criticism.

Burgess described the reports as ‘the great rock n roll swindle’ in a tweet, adding: ‘We need to get answers to this and not let them sweep it under the carpet – they shouldn’t be let off the hook for treating artists with such contempt.’

A petition calling on the Government to negotiate a ‘free cultural work permit’ to ensure ease of travel throughout the EU has received more than 235,000 signatures.

Stars including One Direction’s Louis Tomlinson, former Boyzone member Ronan Keating and singer-songwriter Laura Marling have encouraged their fans to support the campaign.

The Liberal Democrats called on the Government to disclose what was offered by the EU during negotiations.

A spokesperson said: ‘These new restrictions are a blow to the music industry, which has already suffered so much during the pandemic, and will disadvantage young aspiring musicians the most and may make touring financially impossible for some.’

Horace Trubridge, general secretary of the Musicians’ Union (MU), said: ‘With the British music business having been devastated by Covid-19 and with no end in sight to the black hole of cancelled concerts, tours, festivals and regular gigs that is the very bedrock of our world-class industry, the news, if true, that our own elected representatives chose to turn down such an offer is nigh-on unbelievable.

‘Ever since the result of the referendum in 2016, the MU has campaigned and lobbied for a Musicians’ Passport that would allow our members and their support crew to make a successful living across Europe.’

Earlier this week, Cabinet Office minister Lord True said talks with Brussels over visa-free travel for artists were ‘unlikely’ to restart in the near future.

It comes as Cabinet Minister Michael Gove has been warned that confusing post-Brexit rules threatened to cause export chaos.

According to the Guardian, British manufacturing and trade organisations met with Gove in an emergency meeting on Thursday to discuss problems with the deal struck by Prime Minister Boris Johnson in December.  

A source told the newspaper that one leading figure involved in the meeting described the new rules as ‘a complete s***show’ while another said Gove seemed ‘very concerned’.

The source added: ‘He [Gove] seemed to realise the full gravity of the situation that is unfolding and about to get worse.’

On Friday, Gove admitted there would be ‘significant additional disruption’ at the UK border as a result of Brexit customs changes in the coming weeks.

He said efforts to assist would be ‘redoubled’ as traders were urged to ensure their paperwork was in order, with cargo traffic at Dover expected to reach pre-Christmas levels again next week.

It comes as major parcel courier DPD paused some delivery services into Europe – including Ireland – because of pressure caused by new post-Brexit red tape.

Marks & Spencer also revealed that its popular Percy Pigs sweets were struggling to find their way across the Irish Sea to supermarket shelves in Ireland.

The retailer said the new rules and regulations are set to ‘significantly impact’ its overseas ventures in Ireland, the Czech Republic and France.

Mr Gove told broadcasters on Friday: ‘So far disruption at the border hasn’t been too profound but it is the case that in the weeks ahead we expect that there will be significant additional disruption, particularly on the Dover-Calais route.

‘It is our responsibility in Government to make sure that business is as ready as possible, and hauliers and traders have already done a lot but we have to redouble our efforts to communicate the precise paperwork that is required in order to make sure that trade can flow freely.

‘So over the course of the next few days, Government will be stepping up that communications effort to make sure that business knows what is required.’

The latest Government figures show that around 700 lorries have been turned away from the border since new rules came in to force after the end of the transition period with the European Union on January 1.

About 150 fines have been handed out for non-compliance with new rules designed to reduce truck queues in Kent.

But officials said those numbers could increase as the flow of lorries heading through Kent increases, with traffic drastically reduced at present.

Over the past week, there has been an average of 1,584 lorries per day attempting border crossings, which is only around 40% of historical norms, according to the Cabinet Office.

As well as requiring the correct paperwork, including export declarations and the extra certificates needed for products such as plant and animal products, hauliers must secure a negative Covid-19 test and a Kent Access Permit before embarking on their travels onwards to Europe.

The increased push by Government to ready businesses comes as a host of sectors complained about the added complexity that they were having to wade through to trade with Europe. 

A Government spokesman said: ‘Although many businesses have moved goods successfully since January 1, we are aware of some issues, and are providing guidance and support.’

ANKARA/BRUSSELS

<a title="Turkey" href="/search/Turkey">Turkey</a>’s President Recep Tayyip <a title="Erdoğan" href="/search/Erdoğan" rel="nofollow">Erdoğan</a> and European Commission head Ursula von der Leyen on Jan. 9 discussed the steps aimed at enhancing the relations between Turkey and the European Union, the Turkish authorities have said.

In a video conference, Erdoğan and the EU official discussed the ways to develop relations between Turkey and the EU and addressed regional developments, Turkey’s Communications Directorate said in a statement.

The EU is on the priority of Turkey’s agenda, Erdoğan told von der Leyen, reiterating that Turkey sees its future in Europe.

He also pointed out the importance of resuming regular Turkey-EU summits and high-level dialogue meetings.

Turkey wants to open a new page in relations with the EU in the new year, Erdoğan said, adding that the year 2020 could not be made enough use of due to the whims and artificial problems that some EU members produced, according to the statement.

He added that this situation was not sustainable not only in terms of maintaining future relations but also in terms of the broad common geography. Erdoğan also said that updating the 2016 refugee deal would be the first step for a positive agenda on Turkey-EU relations.

Turkey and the EU signed a refugee deal in 2016, which aimed to discourage irregular migration through the Aegean Sea by taking stricter measures against human traffickers and improving the conditions of nearly four million Syrian refugees in Turkey. Erdoğan pointed out that the year 2021 offers a productive environment for new cooperation to be initiated in the field of migration.

The Customs Union agreement between Turkey and EU should be updated, Erdoğan stated, adding that Turkish nationals should be allowed visa-free travel within the Schengen area and steps should be taken in talks on Turkey’s EU accession.

He also mentioned reestablishing mutual trust and rerunning the consultation mechanism. Erdoğan underlined the need for an end to “exclusionary and discriminatory rhetoric” against Turkey.

Von der Leyen, for her part, said on Twitter: “Good exchange with Turkish President @RTErdoğan. We exchanged on the #COVID19 situation, the economic recovery, and the implementation of tasking of the European Council of December 2020.”

Turkey is working to turn new chapters in its relations with the EU, Turkish Foreign Minister Mevlüt Çavuşoğlu said on Jan. 7, noting that European Council President Charles Michel and European Commission President Ursula von der Leyen were expected to pay a visit to Turkey.

The top Turkish diplomat is expected to visit Brussels to hold talks with the EU’s foreign policy chief, Josep Borrell, on Jan. 21.

Following months of strain due to Turkey’s search for hydrocarbon resources in the eastern Mediterranean, Ankara and Brussels stepped up for better dialogue last month.

Last month, at the EU leaders’ meeting in Brussels, it was decided to draw up a list of Turkish targets for sanctions over Ankara’s “unilateral actions and provocations” in the eastern Mediterranean, believed to be rich in energy resources. But they postponed their further decisions such as on trade tariffs or an arms embargo until they have consulted with the upcoming U.S. administration.

Turkey, which has the longest continental coastline in the eastern Mediterranean, has rejected maritime boundary claims of Greece and the Greek Cypriot administration and stressed that these excessive claims violate the sovereign rights of both Turkey and the Turkish Cypriots.

As India’s ties with France have deepened to becoming one of the most consequential bilateral relationships, both countries overcame the limitations of the Covid pandemic to hold the strategic dialogue between NSA Ajit Doval and Emmanuel Bonne, President Macron’s diplomatic adviser. Sitting down for a conversation with TOI, Bonne said, “we work together as sovereign partners, with a strong willingness to address international challenges in a post-Covid world which will make it necessary for like-minded countries to join forces.”
1. What were your discussions with NSA and the Indian leadership?
My discussions are part of the Indo-French Strategic dialogue, where we talk in full confidence on a wide range of security and defenceissues. We have solid, reliable and consistent cooperation on strategic affairs with India. We are committed partners, we have very solid platforms that we work on and we have ambitions. We have a clear vision — in terms of regional security and Indo-Pacific. We’re addressing global issues of terrorism and new threats like cyber. We approach this with one conviction — that we work together as sovereign partners, with a strong willingness to address international challenges in a post-Covid world which will make it necessary for like-minded countries to join forces, based on clear rules and a common understanding of what needs to be done.
2. How would you describe our present cooperation in the Indo-Pacific?
The basis for our cooperation are the speeches by President Macron in Australia and prime minister Modi at the Shangri La Dialogue. They provide a comprehensive framework of cooperation between France and India in the Indo-Pacific. It is based on realities, on shared security needs and shared values. India is a major player in this region but France is also a country of the Indo-Pacific, through French territories, military presence and maritime economic zone in the region. This gives us the leverage for very operational cooperation with India. Primarily in the area of maritime security, but also through increasingly ambitious cooperation on issues such as preserving the environment, the blue economy, and investments that are consistent with international standards and sustainable development.
3. How is the India-France-Australia trilateral working?
The basis of our cooperation is bilateral. But this can be enlarged, with partners like Australia. This trilateral dialogue has begun in September 2020 and has already proven very fruitful. We believe like-minded countries with shared democratic values, can shape the global agenda.
4. As India steps into the UNSC, do France and India have areas of common interest?
France campaigns very actively for India to become a permanent member of the UN Security Council. We believe India has the legitimacy to hold a permanent seat and would make a decisive contribution to international peace and security. In 2021-2022, we want to work together in the UNSC on an ambitious agenda — in- including priorities for France like the Middle East and Africa — and to help bridge gaps in the international community on the most pressing issues. Like the Iran nuclear is- sue. We need India to work with us on finding the right method and the right way to ensure Iran get back into full compliance with the JCPOA and on engaging with other partners for Middle East peace and security and global stability.
5. Terrorism is a priority for both France and India and you have worked closely in FATF. What are the next steps?
Terrorism is a long term threat. When our country was the victim of terrorist attacks last October, India’s public and clear support was invaluable. Now, we should continue to develop our operational cooperation and mobilise the international community to be more consistent and efficient against all terror threats. Terrorism financing is a key issue in this respect, and we are glad India will host this year the third edition of the “No Money For Terror” initiative, that France launched in 2018. Countering hate speech and terrorism inciting on the internet is another field in which we can cooperate. Finally, in the UNSC, India will chair important committees related to the fight against terrorism: we will work together on issues like adopting sanctions against terrorist groups and individuals and their implementation.
6. India’s greatest security challenge is China. How do you see that?
When it comes to the regional environment of India, we trust the Indian authorities to find the right solution with neighbours through peaceful dialogue and negotiation, in order to settle long-standing issues. France, as a permanent member of the UNSC, has a particular role to play in international peace and security. We’re committed to international law, and the peaceful resolution of disputes.
8. India sees China as an aggressor, not only against India but in the region. Do you agree?
When it comes to China, France and its European partners have a very clear strategy, which was set out by the European Union in 2019 which defines China in three words — a partner, a competitor and a systemic rival. What we’re doing with China is to work on conditions which take into account the importance of the role China has to play in international life, but within a very clear framework of international rules. We want to be able to operate with Chinese authorities on the basis of international law, international standards, respect of security of all our partners. It’s both a demanding and engaging approach, aiming to both promote our interests and obtain positive commitments from China— this is true in everything we’re doing.
8. What’s the next step in Rafale acquisitions. Is it co-development?
Defence cooperation is part of our strategic partnership. We are a reliable defence partner of India in the long run. We are proud that all the Rafale jets have been de- livered on time despite the pandemic. As for new opportunities: we are ready to meet Indian needs and requests, to help India enhance its strategic autonomy.
9. Where are we on the Jaitapur nuclear power project? Do you think we can conclude negotiations any time soon?
We are confident we can find a way forward to conclude the negotiations. In a context where our countries are engaged in a green transition, we need an energy mix which includes renewable energies. – We have many Indo-French initiatives in this sector, such as the International Solar Alliance. – but nuclear energy is also a key component of the energy mix.

In March of 2019, the European Parliament and Council enacted Regulation (EU) 2019/452, which established a framework for the screening of foreign direct investments into the European Union. The regulation, which entered into force in April of the same year, applies to transactions taking place post-October 2020 onwards.

The FDI Regulation repre­sents a crucial shift for the EU, as for the very first time, screening of foreign direct investments is being regulated at EU level. In fact, this development has the potential to significantly impact those investors from third countries that consider investing in the EU. More importantly, it can also be of relevance to the interests of EU investors.

As the FDI regulation does not impose a strict regime for EU-wide FDI screening, the final decision on FDI screening rests with the EU member states, which remain sovereign in this crucial area. The focus of the regulation is more on the principles of coordination and cooperation between member states.

“This is a great step in the right direction which will certainly contribute towards an increasingly harmonised and robust screening of FDI in the EU” said Mario Galea, chair of the newly-established offices for National Foreign Direct Investment Screening (NFDIS) in Malta.

Locally, the office has been set up in order to implement this regulation, with the ultimate aim being the protection of EU intelligence, knowledge and technology, as well as its security interests.

The sectors which will be subject to screening are varied and include infrastructure, energy, transport, water, health and communications, among others. A full list can be accessed on the NFDIS website (https://www.nfdismalta.com/).

All interested practitioners, including audit, legal firms, business consultants and all practitioners who are in any way involved in the promotion of foreign direct investment are, therefore, encouraged to get in touch with the NFDIS Office and get updated on the new procedures governing the registration of new investment in Malta.

Practitioners will be informed how they will be required to submit all relevant applications for such purpose with the Office, prior to relevant submission with the MBR. The applications will require determinate information, relating to the investment and ownership structure, including information on the ultimate investor and beneficial.

In case of doubt, the service provider may seek an initial opinion from the Office which will give the necessary guidance as may be required in the case in question.

The Office wishes to reassure practitioners that it is not its intention to create any unnecessary bureaucracy. In fact, in those cases where it is clear that the activities do not require screening, the Office will seek to provide its green light within 24 hours.

In the cases where screening will be required, this will be undertaken with full due diligence on the activity and on the ultimate beneficial owner. This process will take some time to conclude, although the Office will endeavour to conclude the process in the shortest time possible while not compromising, in any way, the extent and quality of the screening to be conducted.