The European Medicines Agency (EMA) has released its Brexit plan
The European Medicines Agency has recently stated that it aims to relocate to another EU country as part of its continuity plan, set in response to the Brexit vote in the United Kingdom and preserve the Agency’s ability to protect both public and animal health.
Since the vote, staffing levels within the UK healthcare sector have reached an all-time low, with many EU nationals now seeking to leave the country due to current tensions. In 2016, there were 209,000 EU nationals working in the sector, according to the Office for National Statistics (ONS), but now numbers have decreased by 27,000 between January and March this year.
The UK is heavily reliant on a strong EU labour workforce, but the number of EU nurses registering to work in the UK reached an all-time low at 96%, according to The Guardian. Consequently, three priority levels have been outlined by the EMA to ensure a consistent level of skilled workers continue to see the UK as an attract place to live and work.
“Preparing for the move, managing the necessary changes, and addressing challenges such as possible losses in skilled and experienced staff, in a proactive and efficient way, requires considerable internal resources,” said EMA’s Deputy Executive Director and head of EMA’s Brexit task force, Noel Wathion.
"With the business continuity plan we aim to ensure that the assessment of medicines is not disrupted and that patients in Europe continue to have access to high quality, safe, and effective medicines.”
In May, EMA started to scale back activities in the outer layer, so-called category 3 activities, to free up 43 staff by the end of 2017 who are focusing on the preparations for the UK’s withdrawal from the EU and EMA’s relocation. To achieve this, the Agency decided to temporarily suspend a number of activities including:
- The development of the European Medicines Web Portal, a new publicly-available online information source on all medicines marketed in the EU;
- EMA’s contribution to the e-submission project that will allow applicants to electronically submit documents linked to authorisation requests for human and veterinary medicines;
- The development of a transparency roadmap for EMA that lays out future transparency measures of the Agency; and
- Participation in the benchmarking of medicines regulatory authorities in the EU as of 2018.
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The second highest priority (Category 2), consists of activities, such as the proactive publication of clinical data, and various initiatives aimed at promoting availability of medicines as well as some political priorities of the EU, for example, EMA’s contribution to the fight against antimicrobial resistance or the Agency’s interactions with Health Technology Assessment (HTA) bodies.
Category 1 includes the highest priority activities that are either directly related to the assessment and safety monitoring of medicines or vital to maintaining the infrastructure of the European regulatory system for medicines, including for example the coordination of actions to protect the safety of patients in all EU Member States, inspections across the EU or maintenance of the functionality and security of critical IT applications used by all Member States. It is absolutely crucial to uphold these activities as any disruption would almost immediately have a detrimental effect on the health and well-being of citizens in Europe and would also jeopardise production and distribution of medicines in the EUPR
However, with current uncertainty surrounding the Brexit votes, there is an increased concern that patients could be put at risk throughout the negotiations, and severely impact not only staffing, but also create severe delays in treatment and access to essential medicines. The Brexit Health Alliance, which formed upon the announcement of the Brexit vote, is therefore demanding that patients are protected throughout the discussions, and incorporates medical and research professionals, patients and public health organisations.
Niall Dickson, co-chair of the alliance and chief executive of the NHS Confederation, has said: “Patients stand to lose out if we cannot go on collaborating in major medical research studies; if we cannot access new treatments and medical devices as we do now; and if UK nationals in the EU are no longer able to benefit from access to healthcare abroad, and vice versa.”
“It is also vital that there is a firm commitment on all sides to joint co-ordination in response to public health threats.”
The alliance has set five priorities for the negotiators:
1. Secure maximum levels of research and innovation collaboration
2. Align regulations for the benefit of patients and population health
3. Preserve reciprocal healthcare arrangements
4. Maintain robust coordination mechanisms on public health and wellbeing
5. Strengthen funding commitments to the health and public health sectors
NHSX releases new data plans, experts call for transparency
Patients in England will get "greater control" over their health and care data according to new proposals set out by the government.
In a new draft strategy called "Data saves lives: reshaping health and social care with data", Health and Social Care Secretary Matt Hancock says that more effective use of data will deliver better patient-focused care. "This strategy seeks to put people in control of their own data, while supporting the NHS in creating a modernised system fit for the 21st century which puts patients and staff in pole position."
Under the new plans people will be able to access their medical records from different parts of the health system through different applications, to access test results, medication lists, procedures and care plans.
The strategy, published by NHSX, the government department that sets policies for the use of technology within the NHS, follows delays to the creation of a central database of patient records amid concerns over data sharing and a lack of transparency, with critics saying that only a small proportion of the public were made aware of the plans and the choice to opt out.
Kevin Curran, senior member of The Institute of Electrical and Electronics Engineers (IEEE) and Professor of Cybersecurity at the University of Ulster, says that moving health records online raises concerns. "The move to an online app does seem like a natural progression, however there is a difference between having computerised records within our healthcare IT infrastructure and having those records reside on a public facing server.
"Having records inhouse limits the range and type of access – it's far more difficult for remote hackers" Curran said. "There are techniques that healthcare organisations can use to reduce the risk of future data breaches. One way is to make it ‘opt in’, so patients have the choice to decide whether their medical information is moved to a public facing service so that they can access it.
"However, those who do not opt in or download the app instead should have their records hosted in a non-public-facing cloud service. This way, if a data breach does occur, those who never used the app, or not wanted to, will not have had their details released."
The new strategy has been welcomed by some, with an emphasis on the need for transparency. Adam Steventon, Director of Data Analytics at the Health Foundation, said: "Health data has played a critical role in the last year – from tracking COVID-19 outbreaks and developing treatments, to getting people booked in for their vaccines. It is critical that the use of data is accelerated if the NHS is to tackle the backlog of care and address the massive health challenges facing the country.
"It is particularly positive that the government has committed to building analytical and data science capability in the NHS and to improving data on social care. To ensure the full potential of data can be realised, the government must ensure transparency on how it will be used and the rights and options people have, as well as engaging with the public and health care professionals to build trust and show people how their data can improve the NHS and save lives."