Author: admin

Foreword

For decades, the UK has been recognised for its leadership in pharmacovigilance, underpinned by the MHRA’s Yellow Card scheme, which continues to play a vital role in detecting important safety signals early.

As medicines and medical technologies become more complex, used by increasingly diverse populations, and reach patients at greater speed, there are exciting opportunities to further strengthen our safety monitoring systems.

As outlined by Professor Aziz Sheikh in the latest of our strategy blog series, the COVID-19 pandemic demonstrated the potential of a modern, agile safety system. We rapidly digitised the Yellow Card reporting platform, introduced AI to manage large volumes of reports, and combined enhanced passive surveillance with active monitoring of vaccine safety using national usage data and anonymised electronic health records.

With the launch of the Health Data Research Service on the horizon, we now have the opportunity to build on these achievements and apply the same approach across all medicines and medical products – enhancing the UK’s already world-leading, real-time surveillance capabilities and further safeguarding patient health.

Professor Sir Aziz Sheikh is Pro-Vice-Chancellor and Head of the Nuffield Department of Primary Care Health Sciences at the University of Oxford. A leading global authority on primary care, public health and the use of real-world data, he has played a central role in advancing the UK’s capabilities in drug safety, digital health and evidence-based policy.

Guest Blog: Professor Sir Aziz Sheikh

Our current approach to pharmacovigilance has proven invaluable, but it remains largely passive and could be greatly enhanced.  Whilst we’ve moved on from relying on clinicians to tear out a Yellow Card from the back of the British National Formulary (BNF) to sophisticated reporting platforms, the voluntary nature of reporting of cases falls far short of what we should expect, meaning that detecting and assessing safety signals takes longer than we want.– We need a more proactive and systematic effort to identify medication (and related products) associated harm to inform approaches to reducing such risks at the earliest possible opportunity. With our digitised health infrastructure now covering virtually the entire UK population, we have a major opportunity to emerge as a world-leader in next-generation pharmacovigilance capabilities.

The process of digitising the NHS has been long and arduous, but is – thankfully – now nearing completion.  This means that the real-world data emerging out of the back-end of these digitised health record systems can now be linked across the entire care continuum using the unique NHS number (or equivalent in the UK’s devolved administrations) providing an unprecedented foundation from which to build next generation pharmacovigilance systems.  Such systems would allow, for example, the routine running of analyses to estimate the incidence of known adverse events identified during drug development or licensing processes, identification of sub-populations who may be at particularly high risk of drug adverse events, and running formal epidemiological analyses to investigate potential adverse events reported through the Yellow Card scheme or other routes.  An example of such an analysis involved assessing the risk of varenicline, a potent smoking cessation aid, after small-scale analyses suggested that this may increase the risk of cardiovascular and neuropsychiatric risks resulting in a black box warning being issued by the US Food and Drug Administration (FDA) .  Our national retrospective cohort study undertaken in the large, representative QRisk database however failed to confirm these heightened risks when compared with other pharmacological smoking cessation thereby supporting the continued use of varenicline.    

The FDA Sentinel System is now one the largest electronic health record-based database in the world undertaking federated drug safety analyses on up to 170 million patients from around 70 health systems across the US.  Whilst we would not be able to compete with the FDA Sentinel System in terms of numbers, with our UK population of 68 million people we would nonetheless be very well placed to run analyses on a scale that could detect most rare safety signals.  Unlike the US, we also have the distinct advantage of being able to run such safety analyses on the total population thus reducing the risk of bias and maximising generalisability.

Once data pipelines have been built, and data curation and analyses processes have been standardised, there is the potential to automate the most common analyses such that the system of searching for drug related adverse events is in effect “always on” working away in the background.  

Whilst such aspirations might seem something of a pipe-dream at the moment, there has in recent years been considerable progress on a number of the essential elements, including: systematic use of the NHS number, developments in cloud-based dataset hosting, progress in deterministic and probabilistic data linkage approaches, and proof-of principle established during the COVID-19 pandemic that the UK can deliver high quality vaccine and drug safety work – at pace – including on the entire UK population.

The imminent launch of the Health Data Research Service  (HDRS), with substantial political and financial support from the UK Government, offers an unprecedented opportunity to build on the UK’s outstanding strengths in pharmacovigilance to create near real-time whole population capability to support the safe and effective use of drugs to advance human health.

• EBRD lends up to €13 million to Speeex for the acquisition of three Swiss companies
• First merger and acquisition in Kosovo to support international expansion of a local company in the service and technology sector
• Project to promote a diverse and inclusive workforce through new strategy and action plan

The European Bank for Reconstruction and Development (EBRD) is providing a senior loan of up to €13 million to support the international expansion of Speeex, a leading Kosovo-based, tech-enabled business service provider with a strong focus on the Swiss market. This is the first merger and acquisition in Kosovo that supports the international expansion of a local company.

The financing will support Speeex’s acquisition of majority stakes in three Swiss companies – pdc Marketing + Information Technology, Profi Office and Profi Contact – through a newly established Swiss special purpose vehicle. This strategic move will enable Speeex to integrate artificial intelligence into its operations, diversify its already international client base and transfer Swiss best practices to its Kosovan operations, raising service standards above regional norms.

By supporting Speeex’s expansion, the EBRD aims to promote knowledge transfer and job creation in Kosovo, while reinforcing governance and financial discipline. In addition, the investment will strengthen cross-border trade and contribute to the country’s economic development.

Sergiy Maslichenko, EBRD Head of Kosovo, said: “Supporting the growth and internationalisation of dynamic companies like Speeex is at the heart of the EBRD’s mission in Kosovo. This investment will not only help Speeex expand its reach and capabilities, but also foster innovation, create jobs and promote gender equality in the local workforce. We are proud to back a project that strengthens cross-border ties and brings Swiss best practices to Kosovo’s service and technology sector.”

Holger Muent, EBRD Head of Telecoms, Media and Technology (TMT), commented: “We are very proud to expand our long-standing relationship with Speeex, one of the leaders of the tech-enabled services sector in Kosovo. The project will help to further develop Kosovo’s human capital base in the sector and strengthen its international competitiveness.”

Fikret Murati, founder and Chief Executive Officer of Speeex, said: “We are deeply grateful for our cooperation with the EBRD and for its support in enabling our international expansion into Switzerland. This marks the first-ever Kosovan-led acquisition in the service and technology sector, and we are proud to be setting this milestone. Beyond strategic growth, this partnership will drive innovation by strengthening cross-border knowledge exchange and advancing digital capabilities. Most importantly, it will create hundreds of new job opportunities for youngsters in both Kosovo and Switzerland, generating long-term social and economic impact. Hence, it will enhance Kosovo’s European competitiveness in the tech-enabled services sector.”

Founded in 2016, Speeex employs more than 1,600 staff across Kosovo and exports over 90 per cent of its services to Austria, Germany and Switzerland. The new investment will further strengthen Speeex’s position as a high-performing local enterprise scaling internationally.

The project aligns with the EBRD’s strategic priorities for Kosovo and the TMT sector, supporting the growth of information technology (IT) services companies and accelerating the digital transition. It also contains a dedicated focus on improving opportunities for women and promoting gender inclusion in the workforce.

The EBRD is a leading institutional investor in Kosovo, having invested €840 million through 138 projects to date.