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24 May 2024

Medical device companies warned that ignoring climate change could spell disaster

The medical device industry is being urged to prepare for the impact of a climate crisis as hotter summers and more adverse weather events threaten to impact the industry with a surge of patients affected by the rising heat. 

The industry’s impact on the global climate took centre stage at the Medtech Forum 2024 conference in Vienna as representatives from medtech giants including Siemens Healthineers and Philips joined with representatives from the World Health Organization (WHO) and the European Commission to discuss what manufacturers can do to prepare whilst cutting back on their own climate impact. 

The WHO’s Antonius Kolimenakis kicked off proceedings by reminding the audience of the European-wide heat waves of 2022 in which research published in the journal Nature Medicine detailed how there were approximately 60,000 to 70,000 preventable deaths across the continent that year directly linked to the sharp rise in temperature. 

At the same time, panellists were also reminded of the strain that the Covid-19 pandemic put on the European medical device scene in terms of sourcing and supplying goods in the midst of a health crisis, warning that as heat levels rise, supply chains could become stretched thin for manufacturers. 

Speaking to the audience, deputy director for small and medium enterprises at the European Commission, Hubert Gambs said: “It does not surprise me at all that many people think there will be another health crisis linked to climate change. But also, I think it is an opportunity for an innovative economic sector like MedTech. 

“The number of extreme situations is increasing, that cannot be denied by anybody. In Europe what we can do is look at ways to make ourselves more resilient in this challenge. That starts by developing products and devices that are safe and sustainable. Do you think about sustainability when you design a product?” 

The panel discussed the latest report from the European Environment Agency, titled the European Climate Risk Assessment which detailed how climate change over the last 30 years has significantly increased the risk of extreme and adverse weather events. 

Attendees at the event were also invited to take part in an interactive visual world cloud in which they were invited to propose wishes for policymakers they would like to see implemented to combat the climate issue. Vague suggestions such as ‘harmonisation’ and ‘vision’ took top place with most of the audience, whilst specific policy suggestions such as ‘stopping fossil fuel subsidies’ took a backseat. 

The discussion also hit upon a 2020 report from the healthcare journal, The Lancet, in which it was found that the healthcare industry overall contributes to approximately 5% of the total greenhouse gasses causing the sharp rise in temperature. At the same time, the panel highlighted the efforts set out at geo-political events such as COP28. 

Antonius Kolimenakis, called on guests to reduce their environmental impact, adding: “There is a lot of evidence that the climate crisis is indeed a health crisis, around 6.7 million deaths a year are indirectly linked with pollution. Now we can see the direct impact that pollution has on our health. We will also experience floods, droughts - all these things that will also put pressure on things like food supplies which will have an impact on health. 

“I don’t think we have time to discuss planning in the future, the impact of the climate crisis on health is one we are finding out about now.” 

23 May 2024

Medtech Europe CEO urges for industry engagement ahead of EU elections

The 2024 MedTech Forum has kicked off in Vienna, Austria, with MedTech Europe CEO Oliver Bisazza urging visitors to keep a keen eye on the upcoming European Union (EU) elections, as the European health scene looks to compete with its contemporaries in the US and Asia. 

Taking to the podium to launch the conference, Bisazza urged attendees that while EU elections are not the most socially and politically gripping, getting involved will be key to keeping the EU-based life sciences sector going as the continent begins to face stricter competition from the medical device companies in the US and Asia Pacific region. 

Speaking to the crowd at the opening keynote of the event, Bisazza said: “EU elections are not the trendiest or sexiest of elections when compared with national elections, but they are of critical importance. 

“So where is Europe going next? In terms of politics, it could be going in a very fresh new direction very soon. Both at a national level and at the European level. How can medtech companies work with governments to help us all get to where we need to be? To answer that question and inspire a new generation of policymakers who will take power in a few weeks or months, MedTech Europe has released a manifesto.” 

The MedTech manifesto calls on European politicians and policymakers to put medical device advances at the forefront of healthcare policy agendas, urging changes such as an overhaul of the current CE-making system with a focus on efficiency and predictability, as well as pursuing EU supremacy when it comes to supporting AI-enabled medical devices while many jurisdictions across the EU, US and UK grapple with the implications of the technology. 

At the same time, the manifesto calls on the Europe-wide health industry to develop better resilience to outside impacts in the wake of the Covid-19 pandemic, focusing on prevention, healthcare workforce retention, and timely access to care. It also calls for a greater increase in the pool of available healthcare professionals. 

Bisazza added: “Today and tomorrow much will be said about what the next five years could, should and must bring. Engage with that conversation because it is very soon that it will be solidified. 

“Europe went through much in the previous five years, it has had to manage a historic pandemic, as well as wars in Ukraine and Gaza, massive supply chain disruptions, energy inflation and the rise of protectionism and the rise in various austerity programmes. 

“But during those five years, Europe became more agile and resilient. It learned lessons from the Covid-19 pandemic and has put new structures in place to strengthen the continent's preparedness, while, at the same time, remaining engaged with its trade partners around the world. 

“Let me be clear, like many others we too have become concerned from time to time that Europe is trending towards over-regulation. We have expressed many concerns to the EU and policymakers that their very valid leaning indication to regulate, if taken too far, risks ruining Europe's historic leadership space as the global epicentre of MedTech innovation.  

"Despite this, we have reached the conclusion that the EU remains unequivocally attractive, thanks to its vibrant healthcare systems.” 

20 May 2024

Final report says UK infected blood scandal “should have been avoided”

The final report from the seven-year inquiry into the UK infected blood scandal has been published today, concluding that patients were knowingly exposed to risks and the medical catastrophe could have been largely, but not entirely, avoided.  

The British medical scandal resulted in nearly 30,000 people being infected with hepatitis C and HIV, as a result of receiving contaminated blood or contaminated clotting factor products between 1970 and 1991.  

Following years of increasing pressure from campaigners and MPs, former Prime Minister Theresa May announced a full UK-wide public inquiry into the scandal in July 2017. The final report, released on 20 May 2024, indicated that the disaster could have been prevented and that the UK government covered up the scandal “to save face and to save expense.”  

Two main groups of National Health Service (NHS) patients were affected by contaminated blood products. In the 1970s, patients with blood clotting disorder haemophilia – including children enrolled in clinical trials – contracted HIV and hepatitis C from treatments using donated blood plasma. In addition to those with haemophilia, some patients who received blood transfusions during the same time frame were also infected. In total, it is thought that nearly 3,000 people from both groups have died.  

The author of the report, Sir Brian Langstaff said while summarising the report’s findings, “I have to report that it could largely, though not entirely, have been avoided. And I have to report that it should have been.” The report has been presented to the UK House of Commons.   

The UK has long struggled with blood shortages, leading the NHS to issue its first-ever Amber Alert in October 2022. The alert postponed non-urgent surgeries to reserve stocks for critical needs. In 2021, the NHS had to temporarily halt some blood tests over vial shortages.   

In the 1970s, the availability of a new treatment for haemophilia, known as factor VIII/IX, necessitated the use of blood plasma, which was in short supply. This led to the UK opting for imports from the US. Plasma was extracted from donor blood, frozen, and treated to create a powder of pure factor VIII proteins.   

Much of the imported blood was bought from high-risk donors, including prisoners and drug users. One vial could contain clotting proteins from tens of thousands of people, meaning it would take only one person carrying the virus to contaminate the entire batch.  

Pharmaceutical companies Alpha, Armour, Baxter, and Bayer, which produced the infected blood products, have not compensated UK victims. However, in 1997, Bayer and the three other manufacturers agreed to pay $660m to settle cases on behalf of more than 6,000 haemophiliacs infected in the US in the early 1980s.  

UK blood donations were not routinely screened for hepatitis C until 1991. However, in the 20 May report, the government claimed that screening for hepatitis C began as soon as the technology was available. Hitting back in response to this, the chair of the inquiry Brian Langstaff said “it [the comment] ignored all the countries that introduced screening before the UK. This amounts to 23 countries in total - including Japan, Finland, and Spain.”  

The Hepatitis C Trust has said that there has been a surge in hepatitis C tests as media attention surrounding the scandal increased. The trust told the BBC that 12,800 people in England have requested NHS home-testing kits in just over a week, compared with 2,300 in the entire month of April.  

8 May 2024

Biotechs must prioritise ethics to deter GenAI “bad actors”

AI developers in the biotechnology field need to watch out for potential “bad actors”, who could use the technology for malicious purposes, says Thomas Balkizas, the senior director of life sciences at Microsoft. 

At the London Biotechnology Show, taking place from 8 to 9 May, Balkizas led a talk covering the advent of generative AI (GenAI) in the biotech sector. He reported Microsoft data that projected $150bn in savings for healthcare providers by 2026 if they chose to use AI to prevent errors in medication dosing. He said the technology could be used for different purposes such as increasing diversity in clinical trial recruitment, improving treatment options for neonatal care and more. 

At the same time, however, Balkizas highlighted the importance of considering ethical questions in ongoing discussions of AI applications. 

GenAI is AI that can produce text, images, videos, or other types of data using generative models. The technology can learn and adapt to patterns in the data to generate new data. Since the launch of large language models such as OpenAI’s ChatGPT in November 2022 and Google DeepMind’s Gemini in March 2023, GenAI has become a mainstream topic of discussion. 

Balkizas warned that in a biotechnology context, if in the wrong hands, GenAI technology could be used to develop things such as biological weapons. Before a wider framework for AI regulations and ethics is developed, Balkizas stated that individual companies would need to prioritise setting principles to maintain ethical practices. 

Microsoft‘s AI principles include a commitment to designing AI systems that perform safely, even in the worst-case scenario, and developing systems that protect data from misuse and enable privacy rights. Furthermore, the company has prioritised the design of AI systems that do not “reinforce undesirable stereotypes and biases,” says Balkizas. However, he adds that the next step lies in developing more public policies for the correct use of GenAI in biotech. 

In February, Microsoft announced a partnership with 1910 Genetics to use a multimodal AI platform for drug discovery. The tech giant also announced the expansion of its collaboration with NVIDIA in March, combining Microsoft’s Azure platform with NVIDIA DGX Cloud and NVIDIA Clara to build new AI medical imaging models and faster routes to drug discovery.