70% of our medicines come from, or through, the UK, but after it departs the EU, it will no longer be part of our regulatory jurisdiction. We must protect patients, writes Bernard Mallee.
For the past two years, pharmaceutical companies, which discover and make branded, prescription medicines, have been working on Brexit planning, investing huge time and money on potential changes in how medical products will get to patients after the UK leaves the European Union.
The journey a medicine makes, from early research through development and adoption by patients, has several touch points.
The process can take up to 13 years, with the rest of the 20-year patent life used as time on the market before others are allowed to make copies of the drug.
The research-and-development phase, which can cost up to €2bn, involves intensive testing and four stages of clinical trials, before more practical elements, like labelling, packaging and distribution, are considered.
All of these steps can cross multiple geographies, with the European Medicines Agency acting as the regulatory body for the single market for medicines.
Until now, because of regulatory alignment and free trade, medicines can get to patients across the European Union and the UK without barriers.
Brexit changes that, because the UK will no longer be in a single, harmonised regulatory jurisdiction.
Brexit is one of those rare political events whose response requires extreme industry-State collaboration. It is up to all of us, the relevant industry and State players, to work together on a collective Brexit response.
Pharmaceutical innovators identify with these traits and, since June 2016, when the UK voted to leave European Union, they have lived all of them.
The scale of the challenge we collectively face is huge. Ireland has a critical reliance on the UK as a source of medicines. About 4,000 medicines are marketed in Ireland.
Of these, between 60% and 70% come from, or transit through, the UK.
We know that the supply of a small number of these products may be vulnerable for reasons such as their short shelf life, special storage and transport needs, and single-supplier reliance.
The HSE and the medicines regulator, the HPRA, are implementing contingency plans. Revenue is helping to smooth transport channels and prevent delays.
The research-based pharmaceutical industry accounts for just over half the volume of medicines on the Irish market.
We have a responsibility, both to patients and the State, to invest in scenario-planning for Brexit, whether deal or no deal.
Preparations for Brexit have been intense. While risks to the continued supply of medicines post-Brexit can never be fully discounted, they can be managed.
That’s what pharmaceutical innovators have been spending time and money doing.
For more than two years, they have been reorganising supply chains and revising regulatory approvals.
Companies have made complex logistical and supply chain arrangements, including, in some cases, rerouting transport away from the UK.
This work is critical in minimising the risk of disruption to the supply of medicines to patients after March 29.
The importance of medicines to human health means detailed Brexit preparations were essential.
Our industry has engaged closely with all the relevant State actors: the HPRA, the HSE, the Department of Health, Customs, and others.
Lots of healthcare players have a stake in the delivery of medicines and medical innovation to patients. It’s vital that all of them are engaged in a collective Brexit response, coordinated centrally by the State.
Much has been made of the need for patients to stock up on medicines. We do not think that is necessary. Continuity of supply of medicines is part of the standard day-to-day responsibility of pharmaceutical companies.
It’s part of the deal we have with the State on the supply of medicines. Since we are an island nation, there are always two to three months’ supply of medicines in the system anyway.
There is no need for hospitals, pharmacists, or patients to order extra quantities of medicines, or for doctors to issue extra prescriptions.
That would risk disrupting existing stock levels and hinder the supply of medicines for other patients.
Occasionally, disruptions in medicines supply occur due to manufacturing problems or changes in demand.
To deal with that, the HPRA has, for several years, been working on a Medicine Shortages Framework.
It’s aimed at averting stock deficits and reducing the impact of shortages by coordinating how they are managed. The framework is already used to manage an average of 45 shortage notifications each month.
The HPRA’s list of resolved shortages, for the past six months, has a list of 24 medicines.
As an extra safeguard, the regulator is giving consideration to categories of medicines considered most pressing for public health. That work will continue.
Pharmaceutical companies are examining their product portfolios so that, if bridging stocks are required in certain cases, they can easily be made available. This is done through the shortages framework.
As Brexit approaches, this is a time for policymakers across the EU and the UK to set aside politics and work together to protect patients.
Every month, around 45m packs of medicines leave the UK destined for patients in Europe.
Some 37m packs go the opposite way. That’s one billion packs of medicine crossing the border between the UK and the EU every year.
Transport delays at the border are possible, too.
These risks must be anticipated and managed.
As Westminster weighs the next political moves, following the defeat of the vote on the withdrawal agreement, Ireland must continue to plan a coordinated response to a ‘no-deal’ outcome.
For pharmaceutical innovators, patients remain our core focus.
They must be everyone else’s, too.
Bernard Mallee is director of communications and advocacy at the Irish Pharmaceutical Healthcare Association.