Ireland needs to protect its vital pharmaceutical industry by taking the lead in the massive opportunity presented by Brexit, according to a leading industry expert.
Some 30,000 people are directly employed in the pharmaceutical industry here and all of the World’s top 10 companies have substantial operations in Ireland, with over 700 jobs announced in the sector in the past month.
The legalities of pharmaceutical regulation mean separate regimes may apply in the EU and UK post-Brexit, and the supply of medicines could be disrupted without proper planning. However, Ireland can become the regulatory gateway to the EU, but must safeguard its ¤3.22bn annual pharmaceutical exports to the UK, according to regulatory expert Ann McGee, Managing Director (Ireland) of Pharmalex.
“Brexit is a huge opportunity for Ireland to accommodate companies who previously saw the UK as their gateway to Europe,” said Ms McGee, a 30-year veteran in advising and supporting pharmaceutical companies. “These companies are now going to need a European regulatory base because every batch of product released has to be signed off by a qualified person based in the EU – a role defined by EU legislation.
“If a product is manufactured in the UK, their QP will have no legal standing in the EU. “By the same token, firms looking to sell into the UK market will now need to separately register their products in the UK and will need strategic support from companies such as Pharmalex whose regulatory expertise spans both jurisdictions.
“Ireland’s Health Products Regulatory Authority (HPRA) and the UK’s Medical and Healthcare Products Regulatory Agency (MHRA) are currently seen as the two most stringent in Europe.
“By assuring high standards, this places Ireland in the driving seat to become the regulatory gateway to the UK post-Brexit, in the absence of a mutual recognition deal between the MHRA and the European Medicines Agency (EMA).
“We cannot afford to rely on the hope that there will be a deal, and we must presume that the UK and the EU will now be two separate jurisdictions, which will present huge problems to the pharmaceutical industry. “As the seventh largest exporter of pharmaceutical products in the world, it makes absolute sense for Ireland to capitalise on this and become the gateway both into and out of the UK. “At the moment, dual labelling on medicines is allowed between Ireland and the UK. However, this may not be the case post-Brexit.
“A Transition Agreement on dual labelling is under negotiation and its 18-month term may be enough time for a mutual recognition agreement to be negotiated. However, none of this is certain, so it is prudent to plan for the worst case scenario in the short-term.
“Both EU and UK-based companies have a legal responsibility to patients to ensure continuity of supply, and that obligation cannot suffer as a result of the company’s failure to prepare for Brexit. “Even if the UK agrees not to set up its own processes, a company wishing to market its products in the EU and in the UK will need to register those products separately in each jurisdiction. “It is vital that companies on both sides of the upcoming divide act now to ensure continuity of product supply for patients by dealing with the obvious challenges in a planned manner as is their legal obligation.
“Companies in the UK have recognised this, and already warehousing space around Dover has tripled in price because the industry knows that it is going to have difficulties exporting into the EU.” Pharmalex is one of the largest providers for development consulting, regulatory affairs, quality management and compliance and pharmacovigilance worldwide Pharmalex recently merged with McGee Pharma International, an Irish life sciences consultancy working with global pharmaceutical, biopharma, and medical device companies of all sizes.
Managing Director (Ireland) Ann McGee has spent the last 30 years working in the pharmaceutical industry and the Pharmalex team advise and support pharma companies develop, manufacture and distribute medicines safely. With a team comprising a number of former EU and US FDA Regulatory Inspectors, Pharmalex works at a strategic and tactical level with clients, providing holistic advice, guidance and solutions across the entire product life cycle. Pharmalex’s Irish operation is based in Portmarnock.
A global pharma outsourcing company that plans to create up to 130 new jobs in Louth and Meath says Brexit prompted the business to invest in Ireland.
Bill Mitchell, president and chief executive of PCI Pharma Services, said the firm became “attracted” to the Republic because of the UK’s imminent EU departure. The company, a pharmaceutical outsourcing services provider, is headquartered in Philadelphia and bought Millmount Healthcare in Stamullen, Co Meath last year.
Mr Mitchell said that after the UK’s Brexit vote, the company’s international pharma customers “started to tell us that if we want to continue to grow we really need to take care of the Brexit issue.”