HDA UK Media and Political Bulletin – 22 July 2021
Northern Ireland protocol – next steps
Cabinet Office and Northern Ireland Office, 21 July 2021
This policy paper sets out the details of the UK’s proposed approach on the Northern Ireland Protocol.
The impact of the Protocol has been profound economically, politically, socially, and commercially. Within Northern Ireland it has placed strain on institutions which have already been challenged by COVID-19. Such issues have arisen even before the full effects of the Protocol have taken shape and with mitigations in place to reduce its full impact. The policy paper highlights that it is increasingly clear that the problems cannot be solved by the application of the Protocol in its current form.
The introduction of the policy paper by Lord David Frost (Minister of State) and Brandon Lewis (Secretary of State for Northern Ireland) points to the UK Government’s desire for a new approach based on negotiation and eagerness to find a new and enduring consensus. The UK Government believes working together with the EU is the best means of providing stronger longer-term solutions, which requires significant change to the current Protocol.
The policy paper discusses the circulation of goods within Northern Ireland. Under the current Protocol, supply chains have been disrupted and costs increased. The current arrangements are creating considerable challenges to medicine supply with patients in Northern Ireland being put at risk for a number of products from the end of 2021.
In accordance with the Protocol, Northern Ireland aligns with all relevant EU rules relating to the placing on the market of manufactured goods. The current system underlines the principle that there can be parallel arrangements for different goods in Northern Ireland, underpinned by risk-assessed regulatory checks performed by market surveillance authorities to limit the sale of goods beyond Northern Ireland.
The UK Government proposes that this principle is extended to provide a full dual regulatory regime in Northern Ireland. All goods should be able to circulate within Northern Ireland if they meet either UK or EU rules, as determined by UK or EU regulators, and should be labelled accordingly.
The UK suggests that specific provisions for medicines may be necessary. Arrangements for medicines, for example, are so closely linked to the delivery of national health services, and the associated regulation and control arrangements are so substantial, that the risk of diversion into the Single Market is extremely minimal.
The solution proposed by the EU in June is potentially complex to operate because of its need to work within the broader EU framework for regulating medicines; and furthermore it would not satisfactorily deal with certain medicines (such as new cancer drugs) which must be licensed by the European Medicines Agency. The UK Government recommends that the simplest way forward may be to remove all medicines from the scope of the Protocol entirely.
From Factory to Pharmacy
As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.See the Infographic
Apply to become a Member
Membership of the HDA guarantees your organisation:
- Access to leading policy and industry forums of debate and discussion
- Invitations to a range of networking industry events organised through the year, including an Annual Conference and a Business Day
- Representation on HDA working parties, including the Members’ Liaison Group
- A daily Political and Media Bulletin and HDA Newsletters
- Access to HDA policy documents and all sections of the HDA website
- Branding and marketing opportunities