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Northern Ireland will see changes in the regulatory landscape following the issuance of the Windsor Framework on 27th Feb 2023 and the corresponding EU Commission proposal. An agreement, in principle, has been reached by the UK and EU. The new path forward of the Windsor Framework marks a turning point in how both the UK and the EU will work together collaboratively and constructively to ensure that the same medicines are available in Northern Ireland at the same time as they are in the rest of the United Kingdom. Whilst this is a successful result for Northern Ireland patients, this is major change for companies that have made specific provisions in their supply chains for Northern Ireland. The supply chains of companies where provisions and changes were made such as introduction of GB specific pack may be impacted as a result. However, the burden on the UK Pharma supply chain will be eased. Prime Minister Rishi Sunak walks with European Commission chief Ursula von der Leyen in Windsor on February 27, 2023 Pharma companies will need to carefully consider making changes within their processes and supply chains pending the issuance of clear guidance from the MHRA on the regulation changes resulting from the Windsor Agreement and the corresponding EU Commission proposed regulatory changes associated with medicinal products within the Northern Ireland market. Smooth access to the EU market for Northern Ireland pharmaceutical and medical technology firms has been safeguarded within the constraints of the agreement. The pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom.

The European Commission said on Wednesday it would allocate 1.23 billion euros ($1.3 billion) to mental health initiatives across the 27-member European Union and make mental health a pillar of health policy. "Today marks a new beginning for a comprehensive, prevention-oriented and multi-stakeholder approach to mental health at EU level," Stella Kyriakides, EU Commissioner for health and food safety, said in a statement. "We need to break down stigma and discrimination so that those in need can reach out and receive the support they need. It is OK not to be OK, and it is our duty to ensure that everyone asking for help has access to it." The Commission said mental health problems already impacted around 84 million people before the COVID-19 pandemic with an economic cost of about 600 billion euro a year, or 4% of the bloc's GDP. The situation has deteriorated since the pandemic with the war in Ukraine, climate change anxiety and the rising cost of living due to soaring inflation. At a press conference, Commission vice-president Margaritis Schinas called it a "silent epidemic" and said the topic was the last piece in the European Health Union "puzzle".

The UK must act swiftly to fend off competition if it wants to build the world's leading life sciences sciences hub, a new report suggests. A year on from the launch of the government's life science vision, the report commissioned by the the Association of the British Pharmaceutical Industry said although achieving the ambition remained feasible, the UK would need an attractive business environment because its competitor countries were becoming more adept at attracting investment. To achieve the ambition of the vision, the PwC-produced report suggested raising pharmaceutical R&D investment in the UK to build a 'stronger manufacturing and research infrastructure', alongside better investment in, access to and uptake of innovative medicines. It said the UK would also need to adopt a renewed approach to the priority healthcare challenges identified in the government's 'Life Science Vision', which would mean cutting the overall burden on health of dementia, cancer, cardiovascular and respiratory disease and mental health. The report quantified the size of the prize if the vision was implemented in full and the UK could emulate the successes of leading EU countries, which included: £68 billion in additional GDP over 30 years, owing to increased R&D investment £16.3 billion additional annual GDP from increased pharmaceutical exports Supporting 85,000 additional jobs Up to 40 per cent decrease in disease burden across the whole UK - for areas like cardiovascular disease, mental health conditions and Cancer. Reduced variation in speed of access to new medicines within three months of licensing for all NHS patients.

The European Commission is prepared to rewrite European Union law on medicines to ensure stable supply of generic and life-saving medicines in Northern Ireland. In a press statement issued on Friday (Dec 17), the commission said it put forward a package of measures to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland. In the context of the Northern Ireland Protocol, this means that the same medicines will continue to be available at the same time across the United Kingdom. Commenting on the news, policy manager at the National Pharmacy Association (NPA) Helga Mangion said: "We are encouraged by the EU's statement on medicines availability in Northern Ireland, though of course we await the final outcome of the negotiations. We have been talking to the government, the MHRA and other stakeholders about these issues for months, highlighting the concerns of our members in Northern Ireland."

The European Parliament on Thursday adopted a proposal from Brussels to ensure the continued supply of medicines from Britain to Northern Ireland - an issue that had dogged the bloc since London left it. "Great news from the @Europarl_EN today with the overwhelmingly positive vote to ensure the continued supply of medicines to Northern Ireland," tweeted Maros Sefcovic, European Commission vice president who had been leading discussions with London. "The EU is delivering on this lasting solution for Northern Ireland in record time," he added, though the EU Council must give final approval. Britain itself has yet to give formal approval on a move that would avoid potential disruption of supplies as London wants an overall accord for matters pertaining to the Northern Ireland protocol governing post-Brexit trade.

Aspen has committed not to charge more for its six generic cancer drugs for the next 10 years in the UK, according to the Competition and Markets Authority (CMA). The CMA also clarified that "although these commitments were offered while the UK was a part of the European Union" they remain "legally binding". It added: "The CMA has now assisted the NHS to secure binding undertakings from Aspen, under the law of England and Wales, which enshrine the UK elements of the commitments and are enforceable by UK courts, including in relation to the supply of these drugs in Northern Ireland and Scotland." This allows NHS to monitor and ensure compliance by Aspen following the UK's exit from the EU. In 2017, the European Commission began an investigation into Aspen over concerns that the company had engaged in excessive pricing for 6 off-patent cancer medicines.