National Pharmacy Association – Written evidence (MNI0006)
I am writing to you on behalf of the National Pharmacy Association (NPA) members in Northern Ireland in response to the follow up questions sent earlier this month.
Firstly, may I begin by thanking the committee for taking the views of the NPA into consideration as part of their deliberation on the impact of the Northern Ireland Protocol on community pharmacy within Norther Ireland, and welcome the opportunity to respond to the follow up questions as set out below.
It is also worth noting that associated with these responses is the caveat that we are still within the grace period, and it will be some time before the full implications of the Northern Ireland protocol can be fully realised.
Since, the recent NPA submission last July, our members have found that the procurement of medicines has become more difficult and costly. This, in combination with the application of Falsified Medicines Directive (FMD) that is still operable in Northern Ireland, and workforce pressures have added to the challenges. A just in time medicines supply function has now had a reduced choice of product leading to significant price increases.
The NPA recognises that following the pandemic, the cost of medicines has gone up nationally and thus it would be useful if the committee were to investigate further if this has led to further adverse impact on the medicine supply chain within Northern Ireland.
The questions:
As highlighted earlier, over the past year, we have seen several wholesalers and manufacturers exit the UK and Northern Ireland market. This has particularly impacted on our members in Northern Ireland leading to a reduction in the range of products available and choice of manufacturers for a particular medicine. Consequently, the prices of medicines may not be as competitive leading to increase in the overall drug bill.
Community pharmacy teams in Northern Ireland now spend an increased amount of time sourcing medicines, exacerbated by the number of wholesalers and manufacturers who have withdrawn from the market. In October 2022 at a meeting with a cross party selection of MLAs, representatives from the community pharmacy sector revealed that 74% of pharmacists were spending between 1-3 hours per day sourcing medicines, with shortages on approximately 1000 medicine packs per pharmacy per month. Many of our members feel that this situation is continuing to deteriorate.
We acknowledge that the current derogations have protected the supply of medicines. This can be set against the situation where, if such an agreement, with the associated mitigations were not in place or come to an end without necessary safeguards in place, there is the potential for widespread disruption to the supply chain.
It is difficult to ascertain the full impact of the EU’s legislation on medicines, as technically
we are still within the grace period.
The NPA’s members in Northern Ireland inform us of the additional workload in complying with the requirements of the FMD. The associated workload is made more complex by the number of false negatives in the system and the difficulties in working with manufacturers to resolve these.
The NPA suggests that consideration be given to ceasing the application of this directive within Northern Ireland, until further evidence is provided that ascertains that the directive leads to patient safety. but is still concerned around residual issues pertaining to the Falsified Medicines Directive (FMD), and the application of EU law for centrally authorised products (CAP).
The NPA welcomes the newly established NI MHRA Approved Route (NIMAR) that has been set up to mitigate against the unavailability of prescription medicines and notes the increasing number of medicines that are now being supplied through this route. The NPA continues to seek assurance that this process will continue to be responsive to match the current “just in time” mechanism that is currently employed for medicines supply across the UK.
The NPA is concerned that, if not properly aligned, a dual regulatory regime could lead to disruption to the medicines supply chain. Regulatory divergence between Great Britain and the EU could significantly impact the availability of medicines in Northern Ireland and subsequent impact om treatment plans and patient care.
The NPA is assured in part that work is ongoing to reach a mutually satisfactory conclusion to the discussions between the UK and EU pertaining to the NI Protocol and continues to emphasise that one of the best solutions would be to remove medicines from the scope of the protocol. The impact of disruptions to medicine supply on the health of citizens in Northern Ireland must remain of paramount importance within these discussions.
Since the application of the Northern Ireland protocol, the NPA’s members in Northern Ireland have also seen a marked reduction in the availability of parallel imports. The alternative versions tend to be more expensive, and as the NI drug tariff is matched to the
English counterpart, there does not appear to be any provision to mitigate against this increase in costs.
NPA’s members also inform us of shortages pertaining to Over the Counter and Pharmacy Only medicines. This is not only limiting patient choice, but also removing the option of self- care, leading to longer waiting times for GP appointments.
Whilst thanking the House of Lords Committee for its endeavours, the NPA welcomes the opportunity to discuss the points raised in this letter, and to do this please contact NPA Policy Manager
Helga Mangion MRPharmS
On behalf of NPA NI members
30 January 2023