Ireland’s Health Products Regulatory Authority (HPRA) has published its strategic plan for 2021 to 2025. HPRA set out five goals intended to help it emerge from the “twin challenges of Brexit and COVID-19” and deliver better outcomes for people and animals.
The five goals are titled health system partnerships, progressive regulation, communication and engagement, enabling innovation and great people, great processes. By engaging in activities that further those goals, HPRA is aiming to “deliver better outcomes for people and animals through value-driven regulation and partnerships.”
HPRA fleshes out what that will mean in practice in the strategic plan. The first objective listed in the document is to “address current and emerging public health challenges and priorities.” HPRA plans to achieve that objective by collaborating to “manage the regulation and availability of health products post Brexit” and “on the regulation and surveillance of medicines, medical devices, diagnostics and vaccines for COVID-19.”
Through those activities, HPRA wants to minimize the impact of Brexit, strengthen integration with other European markets and ensure COVID-19 products “are robustly regulated and monitored, with up-to-date information provided to all stakeholders.”
Those activities fall under the overarching goal titled health system partnerships. Elsewhere in the plan, HPRA sets out how it wants to increase its “use of proportionate and adaptive approaches for better patient outcomes” as part of its progressive regulation goal. Specific actions covered by the progressive regulation agenda include promoting “greater use of mutual reliance among global regulators” and the “development of greater international convergence and harmonization on regulatory standards.”
HPRA, like its counterpart in the UK, is also planning to engage more with patients to strengthen public trust and confidence. Specifically, HPRA wants to establish a “proactive partnership model based on listening, understanding and communicating with the public” that enables it to “use the voices of patients” to inform its regulatory and safety monitoring programs.
The fourth goal, enabling innovation, features multiple actions intended to promote the appropriate regulation of new technologies and facilitate the work of Irish researchers. HPRA wants to “engage with Irish researchers and developers to identify mechanisms and support initiatives that facilitate the translation of research into clinical practice.”
UK prepares guidance on supplying OTC medicines to Northern Ireland
The UK is preparing guidance on supplying over-the-counter (OTC) medicines to Northern Ireland amid growing concern about the impact of Brexit on cross-border trade.
While the UK split from the European Union at the start of the year, the two sides agreed to give certain jurisdictions 12 months to adjust to the change. Northern Ireland, which
98% of its medicines and medical products from or via Great Britain, was among the beneficiaries of the grace period, which deferred the impact of Brexit on OTC drugs and other health products until 2022.
Lord Bethell, the parliamentary under-secretary for health and social care, set out how the UK government is preparing for the deadline in response to a series of questions in the House of Lords. Bethell said details of the requirements manufacturers of OTC medicines will need to comply with to ship products to Northern Ireland will be shared “in due course.”
The Lord said the government is also working with the European Commission “to resolve any outstanding issues relating to implementation of the Northern Ireland Protocol, including supply of OTC medicines” and engaging with industry to assess the impact of the regulatory changes on the availability of medicines.
Engagement with the Commission has ramped up ahead of the end of a grace period for the trade in chilled meat products in three weeks’ time. Trade in chilled meats between Northern Ireland and the rest of the UK will effectively be outlawed after the grace period. With the UK threatening to ignore the ban and talks
without agreement, the situation provides a preview of the potential tension over the trade in medicines that could arise later in the year.
EU think tank makes case against protectionist pharma trade policies
A European think tank has found supply chains were resilient when threatened by the pandemic and argued against the imposition of blanket policies to protect the minority of vulnerable products.
The pandemic-triggered realization of the perceived risks of relying on cross-border supply chains to get medicines and medical devices into markets has led people to call for steps to lessen dependency on third countries. However, a report by the European Centre for International Political Economy (ECIPE) has warned protectionist policies could do “irreparable harm.”
ECIPE reached that conclusion after calculating that 0.8%, in volume terms, and 6.1%, in value terms, of imports into the EU are classified as “vulnerable” because a significant portion of products come from outside the bloc or because there are a limited number of suppliers. In acting to strengthen supply of that minority of products, ECIPE fears the EU could harm trade in many more medicines. As an exporter, the EU risks being hit by “tit-for-tat reactions” if it enacts protectionist trade policies.
Trade group EFPIA published a statement about the report that highlighted the main findings. EFPIA said the recommendations to strengthen global supply chains and keep them open, and to reduce vulnerabilities by diversifying sources of supply, rather than by reducing imports, will increase the agility, competitiveness and pandemic preparedness of the EU.
EFPIA sees an opportunity for the EU to work toward those objectives through its revised industrial strategy and pharmaceutical strategy. The Commission is now deciding on the next steps of the EU pharmaceutical strategy in light of the recent consultation on its roadmap.
UK and Switzerland authorize Pfizer COVID-19 vaccine in 12- to 15-year-olds
The UK and Switzerland have separately cleared the Pfizer-BioNTech COVID-19 vaccine Comirnaty for use in 12- to 15-year-olds. Like other regulators, the authorities approved the indication extension on the strength of a study that found the vaccine performed similarly in the population and adults.
Officials at the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted the label extension after concluding the safety, quality and effectiveness data show the benefits of Comirnaty outweigh the risks in 12- to 15-year-olds. The Swiss Agency for Therapeutic Products (Swissmedic) took less than one month to reach a decision on Pfizer’s application.
The impact of the MHRA and Swissmedic decisions is unclear. The UK has just extended its COVID-19 vaccination campaign to 25- to 29-year-olds and the Joint Committee on Vaccination and Immunisation is yet to advise on whether to keep vaccinating down to 12-year-olds.
News of the extensions emerged days before the European Medicines Agency (EMA)
it is evaluating the use of Moderna’s COVID-19 vaccine in people aged 12 to 17 years. EMA approved the Pfizer vaccine in children as young as 12 years late last month.
The Medical Device Coordination Group (MDCG) has published guidance on the cards manufacturers of implantable medical devices need to provide under the new regulations. MDCG, which advises the Commission on the Medical Devices Regulation, used the guidance to state the implants that need to comply with the requirement and share details of the required information.
Swissmedic is investigating reports of myocarditis linked to COVID-19 mRNA vaccines.