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This article explores major aspects for United States biotech companies to consider when creating a compliant post-Brexit strategy.
March 29, 2019 is a critical date for United States biotech companies because business as usual disappears in Europe as a result of Brexit. Long favored a location for manufacturing and selling pharmaceuticals and devices across Europe, the United Kingdom will no longer be part of the European Union, and free trade across Europe will change. American firms with UK operations should have already devised a post-Brexit strategy and begun implementing it given the fact that the changeover is just a few months away.
Pharmaceutical companies should be examining their supply chains, their manufacturing processes, and most pointedly, their regulatory situation in order to prevent disruption in serving the 600-million-strong European market. To safeguard the continuous supply of human and veterinary medicines after March 29, US companies need to transfer their marketing authorization to a legal entity in the EU along with the ‘qualified person’ for pharmacovigilance (QPPV) or pharmacovigilance system master files (PSMF). This means establishing a batch release site outside the UK while changing existing logistics, contracts, and other key elements in drug distribution. Similar changes need to be planned for raw materials used in pharmaceuticals if they come from or are flow through the UK.
The European Medicines Agency (EMA), which was previous headquartered in London for more than two decades, will move to Amsterdam, and while US pharmaceutical companies can still manufacture products in the UK after March 29, any testing will need to relocate elsewhere in Europe. These products will require batch release outside the UK to be sold in the EU market.
According to British pharmaceutical executives, 37 million packs of medicine now arrive in the UK from the EU monthly while 45 million packs travel the other way. The EMA's network of regulators keeps the process simple and efficient, but there's no reason why US biotech firms impacted by Brexit cannot achieve a future system that works for them if they examine several key issues and make intelligent choices. Here are some major aspects to consider.
The first step is a close examination of the current functions located in the UK in light of how Brexit might require or suggest a new site. Most pharma companies have strong existing teams in the UK with leading experts and proven talent. However, many American firms are taking stock of where they already have facilities outside the UK, perhaps in countries with large markets such as Germany, France, Ireland, or Italy. Such companies have already come to realize that choosing a new location for their marketing authorizations is the best way to ensure that consumers still get their medications as quickly and easily as possible. Initially, it may be a satellite team that is set up rather than replicating an entire team, which will over time become more important to the company’s strategy. Perhaps relocating manufacturing makes sense as well.
However, any relocation task is complex, particularly for pharmaceutical firms with their knotty regulatory requirements as well as considerations for advanced manufacturing expertise, availability of trained personnel, and other factors. When looking at a potential new site, choose a location that has solid expertise and a background in manufacturing thus giving companies access to many of the skills required for monitoring, measuring, and launching products into the EU framework.
Moving marketing authorizations and regulatory functions from one country to another can be a complex process that varies widely depending on the corporate and regulatory structures in the company. Meanwhile, each of the 26 EU countries has its own regulatory body with its own approach in engaging with companies that are changing their regulatory structures in response to Brexit. According to Rita Purcell, deputy chief executive of the Health Products Regulatory Authority (HPRA) in Ireland and someone who is savvy about how such organizations operate in Europe, "It's important to be aware of how advanced a regulator's planning is about Brexit and their approach to facilitating the easy, successful move of marketing authorizations, batch release sites, and other regulatory functions.
"HPRA consider that they have a reputation for being strong but fair in working with drug firms. We work closely with companies to help them resolve issues while also being committed to maintaining suitable standards and quality," she said. While the regulatory and compliance rules are the same across the EU, stakeholder engagement may be different, and she encourages an approach of early engagement, which is in the best interests of both companies and regulators.
A significant issue for American pharma companies are the regulations in the home country for any drugs manufactured in a firm's European facility. For example, HPRA has been recognized by FDA via an EU mutual-recognition agreement, and therefore, any Irish manufacturing sites only need, in most cases, a HPRA inspection before products can be sold in the US. Companies should check to see if the country they are considering also has FDA recognition.
Given the high number of American pharma companies that have Irish sites, Ireland has long had a rich hiring environment for biotech. However, other European countries also have skilled workers, and Purcell from HPRA suggests assessing if a site under consideration will have an adequate available workforce.
In addition to the process engineers, validation engineers, quality control professionals, and laboratory technicians that work in biotech, far-sighted companies should also examine the supply of professionals with digital and IT skills to staff the industry's increasingly automated manufacturing plants. Purcell suggests that companies also look at the supply of skilled workers in areas like medical affairs, medical writing, regulatory affairs, and clinical trial management in their chosen location.
Not all segments of the biotech industry will be disrupted by Brexit. Fortunately, companies making medical devices sold in Europe will have fewer issues because EMA regulators aren't responsible for devices but rather for medications. Once a European Conformity mark has been obtained, the device can be marketed anywhere in Europe without engaging individual national authorities.
However, US pharma companies that want the smoothest post-Brexit transition need to have a well-thought-out strategy in place now and not wait until it is too late for implementation.