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EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact .

Medicine shortages are a global health problem and are increasingly affecting European countries. Shortages can lead to medicine rationing and delay in critical treatments, with a significant impact on patient care. In addition, patients may need to use less effective alternatives and face an increased risk of medication errors. Ensuring the availability of authorised medicines in the European Union (EU) is a key priority for EMA and the European medicines regulatory network.

The guidance describes the various stakeholders involved in the medicine supply chain and their responsibilities and role in the prevention and management of medicine shortages. It provides ten recommendations for marketing authorisation holders, wholesalers, distributors and manufacturers to minimise the occurrence of medicine shortages and their impact. The recommendations include:

The recommendations are based on the analysis of causes of shortages and regulators first-hand experience in coordinating the management of shortages, and industry associations have been consulted.

The guidance has been developed by the HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use, a joint working group established by EMA and the Heads of Medicines Agencies (HMA) focusing on the availability of authorised medicines, and was presented at a multi-stakeholder workshop on shortages held on 1 and 2 March 2023.

It complements the guidance for patients and healthcare professionals organisations published last year to help prevent and manage shortages of human medicines.

More here:
Guidance for industry to prevent and mitigate medicine shortages ... - European Medicines Agency |

VATICAN CITY (CNS)World No Tobacco Day is observed every May 31 to highlight the harmful effects of tobacco on peoples health and the environment.

Because of the growing evidence of its dangers, St. John Paul II first banned smoking inside all Vatican buildings, including private offices, corridors and any rooms open to the public in 2002. And Pope Francis banned the sale of cigarettes in Vatican City State in 2018. Cigars, for now, are still available.

But centuries ago, when tobacco and its use by Indigenous communities were first discovered during Christopher Columbus expeditions to the Americas, the plant was warmly welcomed in Europe for its pleasurable and purported curative properties.

The Catholic Church played a major role in bringing tobacco to Italy, which is still the number one producer of raw tobacco in the European Union today.

It all started when Cardinal Prospero Santacroce, who was the papal nuncio to both Portugal and France, met Jean Nicot, Frances ambassador to Portugal, in Lisbon in 1561.

Tobacco from the Americas first reached Spain and Portugal through its explorers. And Nicot was such an avid enthusiast, he cultivated the plants in the royal gardens in Lisbon and convinced the French aristocracy, especially the Italian-born Queen Catherine de Medici of France, of its miraculous benefits. The formal botanical name for the tobacco plant, Nicotiana, comes from his name.

Also convinced of its benefits, Cardinal Santacroce brought tobacco to Rome in 1561, according to information provided to the public by a newly opened Museum of the Tobacco Shop in Rome. The tobacco powder or snuff became known as Santacroce powder or santa polvere, that is, holy powder.

Pope Pius IV tasked Cistercian monks with growing tobacco in the Lazio region in the 16th century, and other monastic communities started growing the crop in other regions in Italy.

It was Cistercian Father Benedetto Stella who published a 480-page magnum opus in 1669 titled simply, Tobacco, detailing its origin, history, cultivation, preparation, varieties, characteristics, virtues and versus or cons.

In fact, by that time, clear camps of opposition to tobacco use had formed, most notably against its use before or during Mass. Pope Urban VIII responded to fierce local complaints and banned its use in churches in the Diocese of Seville in 1642. His successor, Pope Innocent X, banned tobacco use inside St. Peters Basilica, but Pope Benedict XIII removed the penalty of possible excommunication in 1725.

On a moral level, the Catholic Church has never defined smoking as a sin, and the restrictions at the time seemed more concerned with problems of decorum and the dirty detritus tobacco use left behind.

On a fiscal level, however, one pope made a bold, innovative move, seeing the role tobacco could play in funding a states coffers.

Pope Alexander VII signed a decree soon after he was elected in 1655 establishing a monopoly over tobacco throughout the Papal States: it was the first nation-state to put tobacco under state control as a source of revenue, according to research by the Museum of Tobacco Shops.

That meant that in addition to the taxes levied on tobacco products, the Papal States reaped large profits from giving out commercial licenses to sellers and from fines to those operating without authorization.

The licensing contracts also included the sale of salt, whose price to the public was carefully controlled by the Papal States as it was considered a necessity.

Pope Benedict XIV had the first tobacco factory built in Rome in the mid-18th century in the citys more rural Trastevere neighborhood where it was powered by water from a fountain on the Janiculum hill.

By 1859, Blessed Pius IX decided to consolidate the three small and decrepit factories in Trastevere into one brand new processing plant that included housing nearby for workers and amenities like a nursery onsite for the women and mothers who worked there, Irene Ranaldi, an expert in urban sociology, told Catholic News Service May 18.

The new building, completed in 1863, included a vast square the pope named after his family, Mastai. And today it is the headquarters of Italys Agency for Customs Duties and State Monopolies.

The tobacco factory would be the last building built by a pope in the Papal States, she said, as just seven years later, the last of the Papal States and Rome fell to the independence movement and the unification of Italy was complete.

Still today, the buildings facade reminds passersby of its original purpose. A Latin inscription reads: Supreme Pontiff Pius IX constructed this workplace from the ground up in 1863 for the processing of nicotine leaves.

Read the original here:
Holy Smoke: A history of tobacco and the Catholic Church - America: The Jesuit Review

WASHINGTON

The U.S. and other Group of Seven nations rolled out a new wave of global sanctions against Russia over its invasion of Ukraine as they met Friday during a summit in Japan. The sanctions target hundreds of people and firms including those helping Russia to evade existing sanctions and export controls. Some of the sanctions focus on additional sectors of Russias economy, including architecture, construction and transportation.

After 15 months of war, the allied nations are still aiming at new targets for financial penalties that block, freeze and seize access to international funds.

Treasury Secretary Janet Yellen said the newest sanctions will tighten the grip on Russian President Vladimir Putins ability to wage his barbaric invasion and will advance our global efforts to cut off Russian attempts to evade sanctions.

But there are limits to how much impact they can have.

A look at the sanctions dynamics:

WHATS IN THE NEWEST ROUND?

The U.K imposed sanctions on 86 people and companies, including parties connected to the theft and resale of Ukrainian grain. It also banned the import of diamonds from Russia. The European Union, too, plans to restrict trade in Russian diamonds.

The U.S. hit individuals and organizations across 20 countries, focusing on people and firms helping the Kremlin evade existing sanctions to procure technology. The Commerce Department added 71 firms to its list, and the State Department put 200 people, firms and vessels on its blocked list.

Additionally, new U.S. reporting requirements were issued for people and firms that have any interest in Russian Central Bank assets. The purpose is to fully map holdings of Russias sovereign assets that will remain immobilized in G7 jurisdictions until Russia pays for the damage it has caused to Ukraine, the Treasury Department said.

HOW EFFECTIVE HAVE THE SANCTIONS BEEN SO FAR?

While the U.S. and other G7 nations have turned Russia into the most sanctioned country in the world, some foreign policy experts question the effectiveness of the financial penalties and point to Russias maneuvers to evade them and press its war effort.

Maria Snegovaya, a senior fellow at the Center for Strategic and International Studies, said Russia has demonstrated a remarkable degree of adaptability to Western sanctions.

She added that the war is relatively cheap for Russia to prosecute, amounting to up to an estimated 5% of GDP.

That is easily manageable for Russia in the next couple of years at least, and the cumulative effect of sanctions is just not strong enough to radically alter that, she said.

U.S. officials defend the effectiveness of the sanctions, and argue that they are not designed to work immediately.

Along with imposing individual sanctions, the U.S. and allies have frozen Russian Central Bank funds, restricted Russian banks access to SWIFT the dominant system for global financial transactions and imposed a $60-per-barrel price cap on Russian oil and diesel.

The Treasury Department on Friday in a new progress report said the price cap has been successful in suppressing Russian oil revenues. It cited Russian Ministry of Finance data showing that the Kremlins oil revenues from January to March of this year were more than 40% lower than in the same period last year.

Despite widespread initial market skepticism around the price cap, market participants and geopolitical analysts have now acknowledged that the price cap is accomplishing both of its goals, the Treasury Department report.

WHY ARE THE US AND ITS ALLIES STILL FINDING NEW TARGETS?

Treasury officials say that as sanctions are imposed, Russian intelligence keeps looking for ways to get around them, requiring constant adjustments.

Newer sanction efforts have been dedicated to the evaders and the facilitators of evasion, who help Russia acquire supplies and technology.

We know the Kremlin is actively seeking ways to circumvent these sanctions, Treasury Deputy Secretary Wally Adeyemo said earlier this year.

One of the ways we know our sanctions are working is the Kremlin has tasked its intelligence services, such as the FSB and GRU, to find ways to get around them.

Among other things, U.S. officials say, Moscow has turned to North Korea and Iran to resupply the Russian military with drones and surface-to-surface missiles.

WHAT MORE IS THERE TO SANCTION?

Treasury officials say future targets could include newly identified firms and people connected to supply chains that help Russia gain materials for the war, front companies that help Russia evade sanctions and rogue actors from North Korea and Iran.

For the past month, Treasury officials Brian Nelson and Liz Rosenberg have traveled across Europe and Central Asia to press countries that do business with the Kremlin to cut off financial ties because of the war on Ukraine.

They are also increasingly sharing intelligence between countries and firms to spot evasion.

There are also calls for the U.S. and allies to confiscate and transfer Russias central bank funds to Ukraine for the war effort.

The G7 countries must sustain and augment their efforts, including by confiscating frozen reserves of the Central Bank of Russia to help fund Ukraines reconstruction, said Jeffrey J. Schott, a senior fellow at the Peterson Institute for International Economics.

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Here come more sanctions: How effective are they are stopping ... - The San Diego Union-Tribune

Event to mark 50 years of European Union membership

Published: Fri 19 May 2023, 6:12 PM

Maynooth University was host to a watershed two-day event marking the fiftieth anniversary of the EU, bringing together politicians, academics, diplomats, policy makers and members of civil society to evaluate the highs and lows of Irelands membership.

On 1st January 2023, Ireland reached a historic milestone - the fiftieth anniversary of its accession to the European Communities. Co-organised by Maynooth University and the Institute of International and European Affairs (IIEA), this event examined the span of Irish membership of the EU from the perspective of policy, politics and transformation.

The conference focused on the most important themes that helped define 50 years of Ireland's participation in European integration, and share insights into events that continue to shape Irelands role within the EU.

Alex White, IIEA Director General said: Since 1973 a key feature of Irelands EU membership has been public debate about Irelands role in Europe, expressed most intensely during referendum campaigns. It has now been 14 years since the last EU referendum in Ireland which is more than a lifetime in politics. But the EU will have to change the way it works. From how decisions are made, to the areas EU members cooperate on, big questions will need to be answered. Covid 19 showed us that Europe working together to supply vaccines was of great benefit to Ireland. So, should health now become an EU competency? That would require treaty change. The IIEA is delighted to co-host this conference, assessing the past 50 years, and looking ahead to the next chapter of Irelands European engagement.

John OBrennan, Jean Monnet Professor of European Integration at the Centre for European and Eurasian Studies, Maynooth University, said: The fiftieth anniversary of Irish accession to the European Union is an appropriate moment to stop and reflect on what has been achieved over 50 years of increasing cooperation with partner states in Europe. Ireland is often viewed as one of the great success stories of the European project. There is lots of evidence to support this view. But we have also made mistakes which complicated relations with our partner states.

The conference will reflect on the lessons we might learn from our participation in the EU and how we can drive forward further transformation of the country, especially through cooperation on climate change, with our EU partner states.

A range of politicians from across the political spectrum gathered at Maynooth University, including Mairead McGuinness, EU Commissioner for Financial Stability, Financial Services, and the Capital Markets Union; former Taoisigh Bertie Ahern and John Bruton and Alan Dukes, former Minister for Finance.

Speakers also included Barry Andrews, MEP, and former Minister of State for Children; Alex White, a former Minister for Communications, Energy and Natural Resources, Marian Harkin, TD and former MEP, and Proinsias de Rossa, a former Government minister and former MEP.

Academics from universities across the island include Professor John OBrennan, Maynooth University, Dr Mary C Murphy, UCC, and Dr Lisa Claire Whitten, Queens University Belfast.

President of Maynooth University, Professor Eeva Leinonen, said: Maynooth University is very closely involved with partners across the EU in addressing many of these key societal challenges, collectively and collaboratively. We now have more than 2,000 students taking modules on Europe in any given academic year. Our University has forged excellent collaborations in research and teaching with universities across Europe, most recently through the Arqus European University Alliance, and we continue to expand that cooperation. The EU is justifiably considered an important vehicle that facilitates and supports such endeavours.

Published: Fri 19 May 2023, 6:12 PM

Original post:
EU will have to change the way it works, Maynooth University ... - Meath Chronicle

19 May 2023

Herbert Smith Freehills

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As we reported last week (27 April 2023), theEuropean Commission has issued proposals for a new SPC regimeacross the EU. Under the new proposal, i) a new centralisedprocedure for the grant of SPCs is introduced for medicinalproducts that have been centrally authorised, and ii) a new unitarySPC to complement the Unitary Patent is introduced. The key pointsto note in this regard are as follows:

This route will only be available to medicinal products thathave been authorised centrally SPC applications on thebasis of decentralised and national authorisations cannot takeadvantage of this route:

Once the Unitary Patent comes into effect from 1 June 2023, itwill also be possible to seek a Unitary SPC on the basis of aUnitary Patent via the same centralised application procedurementioned above:

The changes to the SPC regime attempt to resolve problemsencountered owing to the variation in approach of national patentoffices in their assessment of SPC applications, and are aimed atsimplifying and streamlining the process for applicants. In theCommission's own words:

The cost of seeking additional protection will be greatlyreduced: estimated savings of 137 000 per applicant forreceiving EU27 wide, five-year-long SPC protection, bringing the EUcloser to its main trading partners. The increased transparencyresulting from this centralised procedure will also make it easierfor generics manufacturers to be informed of the protection statusof a given product across the EU, and to make business plansaccordingly.

The proposal requires the repeal and recast of the twoRegulations that currently deal with SPCs for medicinal productsand plant protection products, as well as the introduction of twonew Regulations creating a new unitary SPC, one each of medicinaland plant products. The proposed Regulations will still need to bediscussed and agreed by the European Parliament and the Council ofthe European Union in view of their adoption and entry intoforce.

What is an SPC? An SPC provides an extensionterm for a patent of up to five years, for a human or veterinarymedicinal product, or a plant protection product, that has beenauthorised by regulatory authorities. It provides a compensatoryextension of the monopoly to allow for the time it takes to getproducts to market via the regulatory system. SPCs are currentlyawarded at a national level individually for eachterritory. This has led to some variation in application of thecriteria for awarding SPCs, creating legal uncertainty, proceduralinefficiencies, and many referrals to the CJEU. It had also been asource of concern for stakeholders that in respect of the newEuropean patent with unitary effect (the unitary patent (UP) whichwill become available as an option at grant for European patentsfrom 1 June 2023 when the UPC comes into effect) as no SPC righthad been proposed to accompany the new unitary patent right.

The content of this article is intended to provide a generalguide to the subject matter. Specialist advice should be soughtabout your specific circumstances.

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