WELCOME TO OUR MONTHLY HEALTHCARE UPDATE WITH ALL THE LATEST DEVELOPMENTS YOU NEED TO KNOW ABOUT
Highlights this month include: a rise in the number of healthcare data breaches, what's next for the life sciences sector, and the latest from the Nuffield Trust on the state of UK healthcare system since the UK existed the EU.
HEALTHCARE DATA BREACHES DOUBLED IN 3 YEARS
Since 2009, there have been more than 5,000 major healthcare data breaches in the U.S., affecting the personal information of 370 million people. in just the last three years, the volume and frequency of breaches have nearly doubled, from 368 in 2018 to 715 in 2021. The volume and frequency of breaches have nearly doubled since 2018, from 368 to 715 in 2021. Hacking incidents are the most common type of healthcare data breach to be reported to regulators in the last few years. Phishing scams, ransomware attacks and data extortion attempts affect tens of millions of individuals every year. These incidents do not only compromise the privacy and security of an individuals' health data. There is also the potential for severe IT system disruptions that interfere with patient care, potentially posing serious safety concerns.
EMA ANNOUNCES SECOND PHASE OF EU INNOVATION NETWORK
The European Medicines Agency (EMA) has announced that the Heads of Medicines Agencies have endorsed a second pilot phase on the approach to the Simultaneous National Scientific Advice (SNSA). The second pilot phase will run for a two-year period. This follows on from a positive evaluation of the first phase pilot that ran from 2020 to early 2022, where over 33 pilot requests were received covering a range of medicinal products. The second pilot phase will incorporate an optimised process, on which the EMA published a guidance document. The second phase of the pilot will continue to explore the opportunities and interest in the concept for especially developers of innovative medicines. For the regulators the focus will be on identifying the different needs of the applicants to enhance innovation, support clinical research and applications under the new clinical trial regulation, facilitate and speed up regulatory approval across the entire product development cycle whereas avoiding gaps in early regulatory support.
LIFE SCIENCES - WHAT'S NEXT FOR THE SECTOR
The Department for International Trade (DIT) has published a Board of Trade report on the UK life sciences industry, setting out how the UK can deliver the trade benefits of the national Life Sciences Vision. This report puts forward the Board’s thoughts on: global trends and the importance of the life sciences industry to trade; UK strengths and opportunities within the life sciences sector; and how trade and investment solutions can address challenges in the global life sciences sector. The views represented in this report focus on the measures that the UK may take in the trade and investment environment to improve its exporting position and inward investment portfolio. It suggests that the DIT should continue to utilise and potentially enhance its international commercial healthcare diplomacy, as this will facilitate more dynamic, forward-looking and patient-centric synergies between global health systems, investors, exporters, and the wider international life sciences ecosystem. The Board of Trade believes that the UK can regain its exporting form and continue to attract exciting and innovative investors, by working closely with the NHS and healthcare organisations, academia and research, and government. Free and fair trade can be a force for good and the Board keenly supports the adoption of the approaches outlined above to help improve healthcare opportunities and outcomes for generations to come, here in the UK and across the world.
COMMISSION AND WHO STRENGTHEN CO-OPERATION
Following the EU-WHO Strategic Dialogue on Health, the European Commission and the World Health Organisation have agreed to enhance strategic cooperation in global health security and architecture. They will also cooperate on the implementation of major initiatives, such as the European Health Union and WHO priorities for the 2022-2026 period. The objective is to mutually reinforce the work by both sides across areas of common interest, as called for by the EU Global Health Strategy. This bolsters a strong multilateral system with the WHO at its core, powered by a strong European Union. Many significant elements of global health security will be under discussion in the coming two years. These include the negotiations of a pandemic agreement and of amended International Health Regulations, shaping a permanent pandemics platform, top leadership engagement in global health issues, and financing global health. The Commission and the WHO will equally join forces in digital health, developing a broader roadmap of digital collaboration in the beginning of 2023.
MEDTECH EUROPE PUBLISHES PAPER ON PROPOSED DATA ACT
MedTech Europe has published a position paper on the proposed Data Act, in which it discusses the need to preserve incentives for industry to invest in methods of generating value through data in a balanced and proportionate way. The paper states that the Data Act needs to be clearer in terms of its scope and definitions, clearly aligned with sectoral and horizontal legislation, and must protect trade secrets and other intellectual property rights. MedTech Europe further suggests that the Data Act should recognise the complexity of the healthcare sector, ensure consistency with existing rules on data protection, seek alignment with future legislation, and carefully consider the strict obligations regarding data portability for data processing services.
EU-CHINA BIOPHARMACEUTICAL INNOVATION ROUNDTABLE
The EU-China Biopharmaceutical Innovation Roundtable took place in November 2022. The roundtable was organised by the European Chamber Pharmaceutical working group, the China Society for Drug Regulation (CSDR) and the European Federation of Pharmaceutical Industry and Associations (EFPIA). The intention was to enable an open dialogue on pro-innovation regulatory policies between representatives from the European Pharmaceutical Industry and government officials from the National Medical Products Administration (NMPA), led by Mr. Zhao Junning, Deputy Commissioner of the NMPA. In his keynote speech, the Deputy Commissioner highlighted that Europe and China are committed to strengthening cooperation and dialogue on health and innovation. The NMPA stated it will continue to deepen its participation in international regulatory cooperation, and to further enhance key regulatory policies, notably in relation to drug review and approval, global drug development, and drug risk management.
SELF-PAY ADMISSIONS DIP BUT REMAIN WELL AHEAD OF PRE-PANDEMIC LEVELS
Self-pay admissions dipped in 2022, according to recent figures published by the Private Healthcare Information Network (PHIN). However, they remain significantly ahead of pre-pandemic levels. The highest rate of increase was in hip replacement admissions, which grew by 184% on pre-pandemic levels to 4,940. Growth in admissions for knee replacement operations were up 153% on Q2 2019 to 2,465. Trauma and orthopaedics and ophthalmology are the specialties with some of the highest NHS waiting lists. In October 2022, more than 641,000 people were waiting for routine NHS eye treatment with an average wait time of 12.6 weeks. Almost 795,000 people were waiting for trauma and orthopaedics with an average wait time of 15.2 weeks. Independent healthcare providers reported similar levels of private patient admissions in Q2 to the previous two quarters at 200,000. This is slightly lower then Q1 but remains higher than pre-pandemic levels.
HEALTH AND BREXIT: SIX YEARS ON
The Nuffield Trust has been monitoring the effects of the UK's exit from the EU on the UK health care system since 2016. The Trust's latest research suggests that Brexit and its changing relationships with neighbouring countries are exacerbating the severe challenges facing health in the UK today. Several key points are made in the Trust's latest update. The first relates to the decline in EU recruitment and registration. The number of nurses joining the UK register from the rest of the world has risen from 800 in 2012/13 to 18,000 in 2021/22. However, this is not sufficient to make up for ongoing shortages in nursing and cannot be a replacement for adequate workforce planning to recruit and retain staff domestically. Also, some essential specialties of medicine facing chronic shortages have seen EU and EFTA recruitment drop off without increases from other countries compensating for this. For example, cardiothoracic surgery's previous reliance on European staff has slowed to almost nothing, with no increase in rest-of-world recruitment. Finally, there have been unusual increases in medicines shortages. The number of price concessions granted by the government when medicines cannot be found at the usual price has jumped significantly since 2016 and has recently soared to record highs. The latest shifts illustrate how drops in the pound due to Brexit and the September 2022 Fiscal Statement appear to make it difficult for the NHS to obtain medicines under the cost controls it has relied on. For other G7 states, medicine imports have risen steadily in total value since 2016. For the UK, they have reversed and fallen back to where they were a decade ago.
WHAT CAN THE NHS LEARN FROM OTHER COUNTRIES ON WORKFORCE PLANNING?
In his Autumn Statement, Jeremy Hunt, the chancellor, reiterated the government’s commitment to delivering long term healthcare workforce projections over the next 15 years. This is seen as a step towards establishing a sustainable workforce plan for England. Several countries such as Belgium, France, and Australia, have made workforce projections a more consistent and embedded part of their overall workforce planning, which can offer important insights for England. However, even in countries with more robust approaches to workforce planning, staffing shortages have been a consistent challenge. Workforce modelling and planning will never be an exact science because they require assumptions about how the supply and demand for services will evolve. One common issue is that most health workforce planning models are developed separately to policies affecting staff pay and conditions, education, migration, and retirement. While it is important that the UK government has committed to establishing a more transparent and comprehensive approach to estimating staffing needs within the NHS, the experience of other countries makes clear that this will not solve all its problems. The value of projections depends not only on how well the model can predict and accommodate for different staffing scenarios in the short term, but also on its ability to influence and meaningfully inform policy direction in the long term.
A NEW ERA FOR THE ELECTRONIC PATIENT RECORD?
Integrated Care Systems (ICSs) have been allocated £2bn to spend on delivering digital health records and interoperability across all NHS Trusts. To maintain momentum, the ICS’s will need to quickly organise the £2bn across hardware, software, electronic prescribing systems, electronic referral systems and interoperability. 86% of UK NHS Trusts now use Electronic Health Records (EHRs). However, results published in 2022 show only 23% of NHS trusts are using EHRs that meet the required standard. The Healthcare Information and Management Systems Society (HIMSS) Electronic Medical Record Adoption Model (EMRAM) score is an international quality standard which measures the adoption and maturity of a health facility’s inpatient EHR capabilities from stage 0 (least digitally mature) to 7 (most digitally mature). While the plan’s target is for all NHS hospitals to reach at least EMRAM stage 5 by 2025, currently a third of NHS Trusts are rated stage 0-4, with only eight NHS Trusts rated as either HIMSS EMRAM stage 6 or 7.