Healthcare Hot Topics – March 2024

The Information Commissioner’s Office (ICO) has issued a reminder to all app developers regarding the paramount importance of safeguarding users’ privacy. This follows on from a recent review of period and fertility apps, in which the ICO carefully scrutinised these apps to assess their handling of personal data, and to determine whether there are any potential adverse effects on users. Last year, the ICO looked closely at period and fertility apps to understand how they process personal data and identify whether there is any negative impact on users as a result. As part of the review, the ICO contacted several app providers to find out more about their privacy practices. They also engaged with app users to understand their experiences.

While no serious compliance issues or evidence of harms were identified, the ICO wants to remind all app developers about the importance of protecting users’ personal information, especially where sensitive information such as health data is involved. The ICO shared four practical tips to help app developers comply with their data protection obligations and maintain the privacy of their users. These are: ensure the apps are being transparent with how they use people’s personal information; ensure that valid consent to use people’s personal information has been obtained; establish the correct lawful basis in order to process personal data, such as consent: and be accountable for any personal information being that is held. The ICO will be following this up with further advice for app users in the coming weeks, which will outline steps they can take to further protect their privacy.

Digital tools have brought new opportunities to enhance healthcare. However they have also created new health security risks, such as cyber attacks. To provide a clearer understanding of these risks,  the World Health Organisation (WHO) has recently published two reports. These are in collaboration with INTERPOL, the United Nations Office on Drugs and Crime (UNODC), the UN Office of Counter-terrorism, the UN International Computing Centre (UNICC), the UN Interregional Crime and Justice Research Institute, and the CyberPeace Institute. These reports identify ways to strengthen health security through operational solutions.

The first report, Examining the threat of cyber-attack on health care during the COVID-19 pandemic highlights the far-reaching real-life impacts of cyber-attacks on health care. During the pandemic, health information technology (IT) infrastructure was increasingly targeted by cyber attacks, at times hindering hospitals from delivering timely care when it was needed most. Health systems globally have turned to digital solutions to enhance the clinical quality and the cost-efficiency of their services. However, this has created digital dependence, which continues to develop, sometimes without careful consideration of new risks and appropriate investment in cyber-security. Sensitive information held by health services, coupled with inadequate security, therefore makes health care infrastructure a prime target for cyber-criminals.

The second report, Understanding disinformation in the context of public health emergencies: the case of COVID-19, reflects on different approaches to counter disinformation.  Disinformation, unlike misinformation, is created with malicious intent to sow discord, disharmony, and mistrust in targets such as government agencies, scientific experts, public health agencies, private sector, and law enforcement. Understanding infectious disease disinformation history and its intersection with public health over time is crucial to formulate effective solutions to counter disinformation. The report examines different types of pandemic disinformation over time, and how perpetrators exploit the audience’s cognitive mechanisms. As part of a broader and long-term ideological or political agenda, or for economic gain, some disinformation messages are professionally crafted and proliferated, requiring WHO and public health partners to be equipped with multi-faceted approaches to counter these threats. The reports justify the critical need to build multisectoral alliances that can harness the benefits of new technologies for improved health and well-being while facing constantly emerging threats.

The European Commission recently published a report, Competition enforcement in the pharmaceutical sector, The report sheds light on the enforcement of EU antitrust and merger rules by the Commission and the national competition authorities (NCAs) in the pharmaceutical sector between 2018 and 2022. The report was drafted in cooperation with the NCAs of the 27 EU Member States, with which the European Commission works in the European Competition Network (ECN). It provides an update to a previous report covering the years 2009-2017 published in 2019.  The report confirms that active enforcement of antitrust and merger rules continues to play an important role in delivering European patients' access to a wider choice of affordable and innovative medicines.

The main findings of the report include: antitrust enforcement has contributed to fairer prices for medicines; merger control has kept medicines' prices lower and markets competitive; and proactive monitoring helped guiding market operators. The report also describes the guidance and coordination initiatives undertaken by the ECN to respond to the coronavirus pandemic, in particular the joint Statement on the application of the EU antitrust rules in the context of the coronavirus outbreak, which was issued by the ECN and the EFTA Surveillance Authority.

For competition policy and its enforcement activities in the pharmaceutical sector to be effective, they need to take account of the particularities and the resulting competitive dynamics of this sector, such as the specific structure of demand and supply involving a variety of stakeholders and the comprehensive legislative and regulatory framework in the different Member States. On this last point, the European Commission adopted on 26 April 2023 a pharmaceutical package proposing to the Council and the European Parliament to revise the EU's pharmaceutical legislation, based on preparatory work in the period since the adoption of the Pharmaceutical Strategy for Europe in 2020. This proposed revision of the pharmaceutical legislation aims at making medicines more accessible in all Member States, available to address risks of shortages, and affordable to national health systems and patients, while supporting competitiveness of the EU pharmaceutical industry, combatting antimicrobial resistance, and ensuring higher environmental standards of medicines.

This comes against a backdrop of continued enforcement in the pharmaceutical sector across Europe but also more widely. Clients in the healthcare and life sciences sectors are therefore in the continued cross hairs of regulators and should ensure competition law compliance is a key consideration in their business dealings. Board directors are particularly exposed at an individual level in the UK and so should be concerned to ensure compliance within their organisation.

Indian pharmaceutical companies have shown interest in working with the Kingdom of Saudi Arabia (KSA), an USD 8.9 billion pharmaceutical market, amidst growing interest from Saudi authorities to procure high-quality drugs from India. A delegation from KSA recently visited India, confirming that the Kingdom is keen to strengthen ties with Indian pharmaceutical manufacturers. Sudarshan Jain, Secretary-General of the Indian Pharmaceutical Alliance (IPA), emphasised KSA's interest in sourcing drugs from USFDA-approved or similarly strict regulatory body-approved plants in India, as reported by the Business Standard.

This collaboration is potentially very lucrative for India and KSA. The pharmaceutical market in KSA was valued at USD 8.9 billion in 2022, with notable growth in the vaccine and biologics segment, estimated at around USD 2.3 billion. KSA is also a strategic location, as it offers India access to the wider Organisation of Islamic Cooperation market. While India boasts a high number of USFDA-approved manufacturing sites, pricing concerns have hindered seamless trade with KSA. However, recent developments have suggested a shift in mindset, with Saudi authorities now showing willingness to negotiate better terms. This could pave the way for enhanced collaboration between the two nations.

The UK Government recently unveiled new measures to drive innovation in science. £100 million has been awarded to biotech projects across the UK to help pioneer new technologies that will help prepare for pandemics, amongst other things. The funding will be given to six new ‘Engineering Biology Mission Hubs’ and 22 ‘Mission Award’ projects across the country, that will look to build on Engineering Biology’s potential to address global challenges, and drive economic growth. This is part of the Government's plan to remove research red tape, to enable scientists to spend more time working on developing new vaccines. The Government has also confirmed that it will be awarding £21 million for the UK Biobank. The Biobank has been given the cash injection for a new robotic freezer, which will be used to store 20 million samples of biological data. This will further support research that is being used to treat diseases like dementia and Parkinson’s.

The Government has announced plans to make access to dental services faster and more straightforward. It aims to: make it faster for patients by using a new patient premium to support dentists to take on new patients; streamline bureaucracy via a wider set of workforce reforms to maximise the skills across dental clinical teams; and by introducing new dental vans to bring dental care to isolated communities. The plan aims to fund more than 1.5 million additional NHS dentistry treatments or 2.5 million NHS dentistry appointments. The Government is also  launching an initiative called ‘Smile for Life’. This will focus on prevention and good oral health in young children, to be delivered via nurseries and other settings providing Start for Life services, and promoted by Family Hubs. As well as this. it will introduce dental outreach to primary schools in under-served areas, and take forward a consultation on expanding fluoridation of water to the north-east of England.

The European Medicines Agency (EMA) has confirmed that all ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025. This date marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU. To help streamline the process, Member States are to implement, where possible, an expedited procedure for transitioning trials to the CTR. Ongoing clinical trials do not need to be halted or ended during the transition from the previous legal regime, the Clinical Trials Directive (CTD).

The EMA believes that application of the CTR will strengthen Europe's appeal as a location for clinical research. The regulation streamlines the processes for the application and supervision of clinical trials, and their public registration: all clinical trial sponsors use the same system and follow the same procedures to apply for the authorisation of a clinical trial, regardless of where they are located and which national competent authority (NCA) or national ethics committee they are working with.

Following a successful trial last year involving over a million users, NHS England has confirmed that this new service will allow patients to see when their prescriptions have been issued and view their prescribed medication. Patients waiting for an elective hospital treatment will also be able to see the average waiting time for their procedure at their local trust, and users without a nominated pharmacy will be able to use a barcode in the app to collect their prescription from any pharmacy instead of needing a paper version. The new features are being added as the NHS runs a campaign to encourage more people to use the app in their everyday lives and help free up time on the frontline. Patients can already use the NHS App to request repeat prescriptions digitally. The number of repeat prescriptions ordered through the app has grown by 45% over the past year, with an average of 3.1 million now requested every month.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a new regulatory roadmap, which sets out the development of new and robust regulations for medical devices in the UK. The new regulations aim to put patient safety first and help to ensure that patients continue to have access without delay to the devices they need. The MHRA believes this roadmap will enhance the UK’s ability to benefit from rapidly advancing medical technology, such as new implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease.

The roadmap also sets out a route to deliver enabling regulation via a series of new Statutory Instruments (SIs). Priority measures to protect patient safety will be put in place this year, with core elements of the new framework intended to be in place by 2025. The MHRA hopes that the planned regulations will deliver greater international harmonisation, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances.