Brexit demands us all to work together for patients

Posted on January, 18 - 2019

There’s a saying in Brussels called going ‘into the tunnel’. It’s when negotiators get together to try to plot a path to resolving Brexit. As the political turmoil continues, one certainty is that pharmaceutical innovators have been meticulously planning for Brexit. For two years or more, they have been reorganising supply chains and revising regulatory approvals. This work is critical in minimising the risk of disruption to the supply of medicines to patients after March 29th.

The preparations have been costly, time-consuming and resource-intensive. They have happened in close cooperation with the Government, especially with the medicines regulator, the Health Products Regulatory Authority (HPRA), the HSE, the Department of Health, Customs and other State agencies. Brexit is one of those rare political events whose response requires extreme industry-Government collaboration. While risks to the continued supply of medicines post-Brexit can never be fully discounted, they can be managed. And that is what pharmaceutical innovators, in partnership with others, have been spending time and money doing.

Much has been made of the need for patients to stock up on medicines. The Government has advised that that there is no need for hospitals, pharmacists or patients to order extra quantities of medicines. That could disrupt existing stock levels and hamper the supply of medicines for other patients. The HPRA’s Medicines Shortages Framework is in place to help avert potential supply deficits. The framework is used to manage an average of 45 shortage notifications a month. The regulator’s list of resolved shortages, for the past six months, has 24 medicines. This mechanism should help avoid the need for stocking up on medicines. 

While the industry as a whole is not planning to hold significant stocks of medicines, companies are examining their own product portfolios so that, if bridging stocks are required in certain cases, they can easily be made available. In the event of a ‘no-deal’ Brexit, complex arrangements have been made by companies, working closely with the HPRA, to secure continuity of supply. These include highly evolved logistical and supply chain arrangements, including re-routing transport away from the UK and activating the dispatch of bridging stocks of certain medicines identified at the individual company level.

The Government side has advised that the distribution system already holds enough stocks to help absorb any short-term delays that may arise. As an extra safeguard, consideration is being given to categories of medicines considered most essential in the clinical setting.

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. It is up to all of us, both industry and the Government, to work together on the Brexit response. Our overriding priority is the patient. Now is the time for cool heads, for planning, for taking responsibility, for teamwork and collaboration, and for putting patients first.

Bernard Mallee, Director of Communications and Advocacy, Irish Pharmaceutical Healthcare Association