Manufacturing & Supply Chain

By John Whelan 

International policy leaders attending the recent Bio Pharma Ambition conference in Dublin Castle were addressed by Dr Lorraine Nolan, the chief executive of Ireland’s Health Products Regulatory Authority and a member of the European Medical Agency (EMA). She stressed that continued  good working relationships with the UK regulatory MRHA, would be essential for the ‘transition period’ after the UK leaves the EU in March next year , so that the pharma and biotech companies here can transit smoothly to a new framework.

It was abundantly clear from all business leaders as well as academics and researchers at the conference that there was an enormous amount of cross collaboration between the medical, pharmaceutical and medical devices companies here and in the UK. Disrupting these links will clearly be painful and costly to all both sides of the Irish Sea.

There was also concern that the EMA‘s move to Amsterdam – now breaking down into a shambles due to delays in availability of the new offices to move into – that many will not move from the UK. Dr Nolan highlighted the major contribution of the MRHA to the work of the EMA along with the loss of capacity and expertise within the EMA – both from a review of medicines and pharma vigilance – should the UK withdraw from the European regulatory network.

Amongst the many senior industry leaders at the conference, there was strong concern that the UK was heading for a ‘disorderly withdrawal’ from the EU and its single regulatory arrangements.

Recent statements from the UK health secretary Jeremy Hunt would indicate that this concern is not misplaced. In January  he said that leaving the EU meant there would be “separate regulatory arrangements” and that he did not expect the UK to be part of  the EMA because it would entail being “subject to the European Court of Justice.”

The significance of the ‘separate regulatory arrangements’ is that this brings double testing and double the applications for approvals before medicines produced here for sale across the EU, would be saleable in the UK .

Some companies who primarily export to the UK may decide it is more efficient and less costly to move operations across the Irish Sea. When you look at the €4.8 billion of pharmaceuticals we export each year to the UK, there are undoubtedly some manufacturers who will find it imperative to shift plants over. It may be the only way they can be sure of retaining the major supply contracts they have with the British National Health Service (NHS).

One of the big concerns for the Irish Pharmaceutical Healthcare Association (IPHA) is that the supply of many commonly used medicines such as aspirins, paracetamols, strepsils; lemsips etc imported daily from the UK will be disrupted. But also a wide range of innovative rare condition drugs also come to us from the UK. The reality is that we rely on the UK for €2.9 billion of pharmaceuticals for our hospitals, chemists shop supplies and for basic ingredients for Irish life sciences industry. If these issues were not sufficient worry for the pharmacists around the country, there is also the cosmetic side of their business which imports lipsticks, face creams and body lotions from the UK. These are also under regulatory control the same as medicines and will be impacted if the UK opts for a hard Brexit  and its own regulatory regime.

Martin Shanahan, IDA chief executive put the best spin on the impending impact of a hard Brexit by pointing to the Pharma group MSD announcement of plans for a new biotech facility in Dublin, in a move that is expected to create 350 jobs. The MSD managing director Ger Brennan, in a veiled reference to potential Brexit issues, stated at the announcement: “We need to have confidence in supply.” And yes there is also the opportunity for Ireland to attract some manufacturers from the UK to set up parallel plants in Ireland to services the rest of the EU.

However, for  those in  need of medical care and especially the most vulnerable among us such as those suffering from rare conditions,  it is imperative that uncertainty is minimised throughout the Brexit negotiations and as much continuity as possible in the regulatory process between EU-27 and the UK is ensured.