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
Slovenia launches EU COVID pass built on Better Platform
Slovenia has launched its EU Digital COVID Certificate, also known as the Digital Green Certificate, which was developed in only three weeks and built on top of a national clinical data repository (CDR) powered by the Better Platform.
The service generates a certificate based on the data available in Slovenia’s national CDR. The COVID certificate uses integrated care record data such as demographic data, vaccination and test result data that is already available. The data is made available through previously established services by the national COVID-19 screening data management solution and the national eVaccination registry – so there is no need for additional data to be generated solely for certificate purposes.
This rapid development of EU Digital Covid Certificate was made possible by an open-platform approach. It has also been created so that it can used by different systems, providing a vendor-neutral exchange of documents, and is available on-demand in digital or PDF form, with QR codes.
The COVID-19 pandemic pushed national health systems to quickly develop new digital solutions for including to manage epidemiological data, and organise COVID-19 tests and vaccinations. The EU Digital COVID Certificate is the latest example of a solution that was developed at this new fast pace to allow citizens to travel safely this summer.
The Slovenian healthcare system already had a national eHealth infrastructure, enabling data to be shared via an integrated care record that makes data available for any digital service instantly, at scale and volume.
Currently, Slovenia's healthcare system includes:
* more than 150 million health records for 2.1 million unique individuals (98% of the population)
* more than 86% (135 million) of records in the form of structured data that uses openEHR models
* more than 4 million records of COVID-19 test results
* unstructured data that includes discharge summaries, clinical notes, opt-in statements, consent documents and other clinical data
* data which is sent to the national system by more than 1,250 registered healthcare providers in Slovenia
Initially, the digital health platform enabled the Slovenian Ministry of Health to respond rapidly and deploy a COVID-19 screening data management solution on a county-wide level in just 14 days. With vaccination data available through the national eVaccination registry, there was no need for additional data to be generated solely to create the COVID certificate.
“We are happy that we already had the suitable IT infrastructure in place in Slovenia" said Minister of Health Janez Poklukar. "It allowed us to respond quickly and provide the necessary digital solutions that support the efforts of medical and epidemiological teams to manage the pandemic, as well as to allow our citizens to travel freely.”