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With drug shortages still a global issue, medications to treat cancer are in particularly short supply. Europe is running out of some key chemotherapy agents that are off-patent and available as generics.

The European Medicines Agency (EMA) reports 20 products in ongoing shortage, of which several are used in oncological care. These include the chemotherapy agent nab-paclitaxel, both the original Abraxane, manufactured by Bristol Myers Squibb, and generic versions, key supportive care drugSanofis Elitek (rasburicase), and Roches Actemra/RoActemra (tocilizumab), a biological agent used to treat some severe side effects like cytokine release syndrome of cell-based oncological treatments. The Elitek shortage has been due to a delay in transferring the manufacturing process, whereas the increased demand for nab-paclitaxel and Actemra has outweighed current production capacities.

Dr. Dario Trapani is a breast oncologist and chair of the Cancer Medicines Committee at the European Society for Medical Oncology (ESMO). He says the increased use of nab-paclitaxel, especially as part of more innovative treatment regimens, has been one key driver of the shortage.

I see a broader clinical use and an increased demand has not been counterbalanced by more production. Also, in the post-pandemic era, we may still experience consequences of the use of some of these agents for COVID-related complications, that may be the case for tocilizumab, amidst greatest increase of demand.

Professor Jean-Yves Blay, ESMO director of public policy, cites a key survey on medicine shortages conducted by the Pharmaceutical Group of the European Union (PGEU) in 2022. Among groups representing pharmacies in 29 European countries, including European Union (EU) member states as well as Turkey, Kosovo, Norway and North Macedonia, almost 70% of the countries experienced a shortage of antineoplastic and immunomodulating agents. The oncology drugs bleomycin, vinblastine and vinorelbine are also reportedly in short supply in the EU.

Trapani says drug shortages in Europe are currently lasting around two to four months, but these are periods of unacceptable austerity as often these medicines have few or no proven effective alternatives. This is having a detrimental impact on the health of patients and the sustainability of healthcare systems.

Recognising that drug shortages cannot be addressed by any single country in isolation, ESMO launched a Call for Action in 2019 with key recommendations. Some of the issues have been addressed in the European Commissions proposal, published in April 2022 which states that the EMAs Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) will be tasked to adopt a list of critical medicines that require coordinated EU-level action.

Blay explains that one proposed legislative measure is the repurposing of medicinal products which, combined with the use of off-label medicines, offers an opportunity to combat medicine shortages for cancer treatments.

It is a positive step that the proposed legislation allows entities not engaged in an economic activity to submit substantive non-clinical or clinical evidence for a new therapeutic indication, Blay says. Repurposing of medicines is also crucial for rare cancers taking into consideration the limited availability of rare cancers medicines. [These] should be considered as a priority, included into shortages prevention plans and also into the European list of critical medicines.

Another possibility that could mitigate medicine shortages is a joint procurement of cancer medicines conducted by the European Commission which could allow the EU to negotiate prices for all EU member states. These negotiations will also be able to set a delivery date for medicines, especially for oncological drugs.

The European Commissions proposal has now been sent to the European Parliament (EP) and the EU Council for consideration and adoption of their positions ahead of entering a trilogue negotiation.

Three co-legislators will agree on the final legislative text which is expected to be adopted late 2026 or mid-2027, says Blay. However it is still subject to change. ESMO is committed to working with the EU institutions to ensure that this revision is completed.

In the last 30 years, there has been a steady offshoring of active pharmaceutical ingredients (API) production away from Europe. The current share of global generic API production value is 66% in Asia Pacific (India and China), 24% in the EU, 3% in North America, and 7% in the rest of the world, confirms Blay.

The limitations that come from reliance on imports were evidenced by the pandemic which initiated a discussion on strategic autonomy, industrial policy, and EU investment in right-shoring API production in Europe.

Blay adds that in 2021, the European Commission included APIs as one of the areas that can be considered strategic for Europes interests in the context of the EU Industrial Strategy.

More recently, in May, 19 EU member states published a non-binding joint proposal to improve the security of medicines supply in Europe, including drugs to treat cancer. It includes the following approaches:

Trapani adds: While I cannot state for sure that right-shoring is the ultimate and unique solution in the post-pandemic era [] I hope to see more of this for manufacturers of generic drugs, to enhance capacity and presence in the market.

Accountability and monitoring are the key to better prevention and management of shortages in the European Union (EU). Demand-supply gaps require continuous monitoring through digitalised infrastructures that are centrally reported and controlled.

For many physicians, shortages just happen one day with no notice and you cant prescribe essential cancer treatments! says Trapani. This is not acceptable anymore. I envision a mapping tool, embedded in an EU-based legislation helping implement a strategic plan, including validated response patterns to address the several challenges that EU countries will face across the value chain of generic drugs.

Independent decision-making tools such as this may help support sustainability in oncology. Developing locally-adapted, value-based models of medicine reimbursement, and targeting health inequalities in high and low income settings will also help make optimal care more widely accessible across Europe.

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Cancer treatment uncertainty: European nations struggle with drug ... - Pharmaceutical Technology

The 650-metre-long access road to Beleu Lake has been inaugurated in Slobozia Mare village, Cahul district. The rehabilitation of the road was made possible thanks to the financial support of the European Union, provided through the EU4Moldova: Focal Regions programme, implemented by UNDP and UNICEF.

The 283,000 infrastructure project involved the rehabilitation of the access road, including asphalt surfacing and the construction of 487 square metres of pavement for pedestrians. In addition, the Slobozia Mare town hall has covered, from the public budget, the installation of a car park of 1300 square metres, a public toilet, four streetlamp poles and the installation of guide signs.

The renovated section of the road contributes to boosting the economic development and touristic appeal of the region, as Beleu Lake is part of the Prutul de Jos Biosphere Reserve, included in the UNESCO World Network in 2018. The event took place within the BELEU BIO FEST festival, held on August 13, 2023, which promotes the natural, cultural and gastronomic heritage of the Slobozia Mare region and Lunca de Prutului de Jos. Visitors of the event enjoyed a number of activities such as bird watching, boat and ATV rides, nature hikes, music and dances, and folk crafts exhibitions.

We thank the European Union and UNDP Moldova for the opportunity to access projects that contribute to local infrastructure development. The renovation of the access road to Beleu Lake was included in the development strategy of the locality since 2016, and thanks to the EU4Moldova: Focal Regions programme, this important project for our locality was completed and with it, the area of Lunca Prutului de Jos gained added value, becoming a tourist attraction, noted Valentina Carastan, Mayor of Slobozia Mare village, Cahul district.

Road rehabilitation supports efforts to create economic opportunities for small local producers, tourism service providers and the population at large. This will create better living conditions for local people and generate more income and new jobs.

This road is one of the many infrastructure investments supported by the European Union. As a result, I hope that more local citizens and international tourists will be encouraged to enjoy the natural wonders of this place. In the framework of the EU4Moldova: Focal Regions Programme, the European Union provides almost 23 million grant funding for a more prosperous future for the citizens of Moldova. This will be achieved through investments in quality local public services, improved infrastructure, support to employment opportunities and business development, and setting foundation for participatory & sustainable regional development, said Adam Grodzicki, Deputy Head of the Cooperation Section of the Delegation of the European Union to the Republic of Moldova.

Promoting the cultural and tourist heritage of this special area such as Lunca Prutului de Jos is of particular importance and brings multiple benefits for both the local community and its visitors. It contributes to increasing the attractiveness and visibility of the region, has a positive impact on the local economy, preserves and renews cultural traditions and contributes to the sustainable development of the community, said Valeria Ieeanu, Planning and Partnership Development Specialist, UNDP Moldova.

The construction work took place between June 2022 and August 2023.

EU4Moldova: Focal Regions programme (2019-2024) supports smart, inclusive, and sustainable socio-economic development in Cahul and Ungheni regions, to bring a better quality of life to citizens. The programme has a total budget of 23 million, is financed by the European Union and implemented by the United Nations Development Programme (UNDP) and the United Nations Childrens Fund (UNICEF).

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Access road to Beleu Lake rehabilitated with support from the ... - EEAS

The European Union has passed an initiative that mandates all digital environments be accessible by 2025; this includes both government and private sector platforms. To that end, Denmark is leading the way within the European Union.

The Denmark Minister for Digital Government, Marie Bjerre, welcomed our Cal State Fullerton students to Denmark in a collaborative project with University College of Northern Denmark students and the Aalborg Municipality to create accessible components (User Interface (UI) Atoms and Molecules) for communication platforms within a digital environment. The Danish government wants to make the transition to accessible platforms as smooth as possible for their citizens by providing resources (UI building blocks in the form of Atoms, Molecules, Organisms, and Templates) within these ecosystems to meet this new initiative.

The students from both universities were divided into international teams and asked to do a deep dive into one UI atom or molecule of their choice and incorporate best practices of Accessible Design. To understand the complexity of this assignment, the teams needed to research different types of disabilities and how best to design for them. For example, the I Am Not a Robot page (Completely Automated Public Turing test to tell Computers and Humans Apart (CAPTCHA)) is often inaccessible and is designed for people with no disabilities or just one. Unfortunately, these current designs create barriers to information and inclusiveness in daily life.

After an intense two-week experience, the students were asked to present twice, once to the staff for the Minister for Digital Government and another to the Director of Digitalization for the Aalborg Municipality and her staff. Each team presented solutions that examined designs that incorporated numerous disabilities and the research behind their decision-making. Also, the students research included user testing.

CSUF students were asked to write a self-reflection paper on their experience as part of the assignment. As one student put it so aptly, I truly lived in my own little bubble. I navigated through the world by expecting other people to understand me and that I shouldnt need to change in order to accommodate or care for others. However, through the Insights Profile, working in cross-cultural settings, and even working with people with opposite personalities to mine, I realized there is a great need for mutual empathy and understanding of different viewpoints. From a social understanding, it helped me see the strength in human differences.

From a User Values perspective, students discovered that designing for others with needs unlike their own can be challenging and rewarding at the same time. For example, a mother holding a child will hinder how she can interact with an interface immensely, and if this mother also has dyslexia, there becomes another barrier for her to have a smooth and successful experience. By including audio functions and keyboard functions, we could meet the needs of multiple users who may have multiple disabilities, which is something we couldnt have predicted if we did not research thoroughly.

We also researched the design guide provided by Aalborg Kommune, as it contains the design elements already set in place. By researching, we could gather the clients values and design so they could see it implemented in their existing interface when it was time to present. This was especially important after the sketching process. As we began building the system in Figma, we constantly referred to their guide to keep everything consistent and showed our clients that we valued the practices they already set in place.

The Denmark Accessible UI Design program consisted of 40 students, 18 from CSUF, and six professors (Ren Bennyson, Birgitte Kjoelner Hansen, Claus Andr Stig Christensen and Daniel Bloch from UCN, Sarah A. Meyer from Cal Poly Pomona, and John T. Drew from CSUF). These professors help to run the program and give lectures on the topic.

In addition, Lead Designer Jakob Skovgaard Pedersen from Elsevier gave a lecture on UI design systems, and Executive Director Kate Sonka and Director of Education Rolando Mendez from Teach Access gave a talk on Teach Accesss mission and programs in terms of accessibility and inclusiveness. Teach Access is a nonprofit working to bridge the accessibility skills gap.

We have been running the Denmark program, both inbound and outbound, for ten years, and by far, this was the most meaningful and successful of all of them, says Professor John T. Drew.

To learn more about this and other CSUF faculty-led study abroad programs, visit extension.fullerton.edu/studyabroad.

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Denmark Study Abroad Program Teaches Design and Art Students ... - CSUF News

A potential strike by workers at a liquified natural gas (LNG) plant in Western Australia has triggered a spike in European gas prices.

Benchmark wholesale gas prices for the European Union and UK rose about 10 per cent on Monday, Bloomberg reports.

The Offshore Alliance union, representing workers from the Australian Workers' Union and the Maritime Union of Australia, at the North West Shelf operations in WA, could down tools by September 2 if no pay deal is achieved.

There are concerns that industrial action at Woodside Energy Group's North West Shelf facility would disrupt LNG exports from Australia.

Workers at two other offshore LNG plants, Gorgon and Wheatstone, run by Chevron, are also voting on strikes, with results due on Thursday.

Collectively, the three facilities represent about 10 per cent of the global LNG supply.

Australia, Qatar and the US are the leading producers of LNG.

World gas prices jumped after Russia invaded Ukraine in February 2022 and the Kremlin cut supplies to Europe.

It triggered a race by European nations to find new sources of the commodity, ramping up imports of pipeline gas from Norway and of LNG, mostly from the United States and Qatar.

Europe's success in filling the gap left by Moscow has helped pull natural gas prices down from a record high of about $US331 ($515) per megawatt hour hit last August.

Some analysts believe strikes at the WA facilities would lead to a surge in global demand and higher prices.

Any reduction in Australian exports to Asia could force customers from that region to look for alternative supplies in Qatar, where they would compete with European buyers.

A Chevron spokesperson said earlier this month it was continuing to engage with employees.

Woodside told Reuters it had engaged constructively in the bargaining process with unions.

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Fears of gas strikes in Australia trigger price surge in Europe - 9News

Background

A European Works Council (EWC) is a body that facilitates information and consultation with European employees on transnational issues. EWCs are composed of employees representatives from each country that is a member of either or both of the European Union and the European Economic Area, in which a business has employees. They operate separately from national information and consultation bodies.

The concept of an EWC dates from the early 1990s, when the first EU legislation on EWCs was enacted (Directive 94/45/EC). That legislation was revised in 2009 to strengthen the rights of EWCs and their members (with Directive 94/45/EC being recast as Directive 2009/38/EC). To the frustration of the European trade union movement, however, those revisions did not alter managers fundamental prerogative to manage their businesses.

On 2 February 2023, the European Parliament adopted a resolution approving a report drawn up by the German MEP and former trade union official, Denis Radtke (the Radtke Report). The Radtke Report calls for fundamental and profound amendments to the current legal framework on EWCs. Its most significant suggestions include:

On 11 April 2023, the European Commission launched a first-stage consultation of European social partners on a revision of the Directive. It did so in line with President von der Leyens commitment that the European Commission would follow up on any resolution by the European Parliament calling for legislative reform.

However, and despite the first-stage consultation purportedly examining whether there is a case for EU action, the European Commissioner for Jobs and Social Rights had already indicated that unless the European social partners (BusinessEurope on the employer side and the European Trade Union Confederation on the employee side) indicate that they will negotiate changes to the Directive between them, he will bring forward new legislation by the end of 2023.

The first-stage consultation highlighted six main areas for potential reform, all of which are contextualised by reference to the relevant parts of the Radtke Report:

The consultation further drew out a range of other areas for potential reform, again based on the Radtke report:

Together, such a broad package of reforms would have profound implications for businesses. The Financial Times has recently called the proposed fines for failing adequately to inform and consult staggering and preposterous. It also noted that a company such as Amazon could face a fine of EUR 7.3 billion for what a court accepted was an unintentional breach of a process that, if done correctly, could have resulted in Amazon lawfully deciding to reject the EWCs opinion in any event.

On 26 July 2023, the European Commission launched a second-stage consultation of European social partners on a revision of the Directive. This reflected that it concluded after its first-stage consultation that there is scope for further EU action to improve the Directive, meaning that it is appropriate for it to consult European social partners on the potential areas for reform already identified.

The second-stage consultation will be open until 4 October 2023. Following this, European social partners may enter into negotiations to conclude an agreement between themselves for legislative approval or, alternatively, and noting that the prospects of agreement between the European social partners is low given their responses to the first-stage consultation, the European Commission may itself propose draft legislation.

The European Commission must consult with the European social partners before bringing forward any legislative proposals in the field of social policy. However, and as noted above, it might reasonably be considered to be unlikely that the European social partners will be able to agree reforms between them, especially given the immediate union-side reaction to the consultation. As such, it appears likely that the European Commission will proceed with proposing new legislation in due course.

If and when any new legislation is proposed, we will publish a further client update. In the meantime, businesses with concerns about these proposals may wish to consider seeking to engage with BusinessEurope before the second-stage consultation closes.

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Second-stage consultation launched on significant reforms to ... - Lewis Silkin