IDA Ireland's Vice President of Life Sciences, Mike Storan's article published recently by the BIO conference, held in San Diego on 20-22 June 2017.
Biotechs Need to Maintain Swift Trial Approval processes as EMA Prepares to Move out of the UK
The European Medicines Agency (EMA) is a decentralized agency of the European Union that evaluates the safety of medical products for consumers in the 500 million-strong European Single Market. It has become invaluable in increasing the efficiency of drug regulation across the EU, giving Europeans access to new treatments and new medications quickly. For US biotech companies, the EMA is the first port of call in their efforts to access the EU which accounts for a quarter of all global pharmaceutical sales.
Clustered around the
EMA headquarters in London
are American and other
international biotech companies
who selected that
city in order to be close to
the EMA. This adds ease to
almost all aspects of selling
medicines and drugs to
the European market. But
for those companies who
chose London as a base,
it’s all about to change as
the Agency considers moving
to a new home, outside
of the UK.
Brexit poses uncertainty
During the current Brexit process, under which the UK plans to leave the European Union, the EMA – including its 900-strong staff and many global biopharma commercial operations which have followed it to London’s Canary Wharf – will also be on the move. To where is not yet clear. What is clear however, is that US and other global companies worry a move will mean delays on drug approvals. As a result, the most critical question for biopharma companies now is: how will this affect my pipeline in Europe?
American biopharma companies bidding for access to the EU market also worry about a negative impact on efficiency. The EMA has a good reputation for bringing drugs to market. Since it set up in London in the 1990s, it has increased the efficiency of drug regulation across the EU. For US biopharma companies, instead of seeking approvals from each member states, the EMA gives them one approval process for all member countries in one go. It’s a win-win for all, including EU citizens who have been able to access new treatments and medications swiftly and seamlessly.
The industry faces an uncertain future
The question on everyone’s mind is: How can US biopharma companies continue to get drugs into the market quickly and achieve swift approvals? There aren’t many opportunities for improvement in the short term, but on the flip side, US biopharma companies need to make sure that they keep a swift trial approval processes running because it might be 2019 before the agency is up and running in a new location.
What country makes the most sense?
At least seven countries including Italy, Hungary, Austria, Portugal, Spain and Sweden are all jockeying for the hosting honor, as is Ireland, which happens to be the only English speaking country left in the EU – a considerable plus, particularly for the US market.
Following the Brexit vote, IDA Ireland, the country’s inward investment promotion agency, invited members to discuss what the UK’s decision to leave the EU would mean for business. Even before the decree absolute was signed, the Irish Department of Health under Minister Simon Harris had put together a team to prepare Ireland’s bid.
The Minister contends that Ireland, Dublin in particular, makes the most sense. He cites the city’s growing multi-cultural hub where nine of the top 10 global pharmaceutical companies have a presence; it is the largest net exporter of pharmaceuticals in the EU, and the 7th largest exporter of medicines and pharmaceutical products in the world. Ireland has 33 FDA-approved pharma, and biopharma plants and a $100 million research and trading center: the National Institute for Bioprocessing Research and training (NIBRT); and, it’s an English speaking population.
The bottom line for US biotech
The need for a smooth EMA
transition is critical, especially for
US biotechs, from both a financial
and staffing point of view.
The sooner a new hub is confirmed,
the sooner US firms – most of whom have enjoyed successful
collaborations over the last few decades – can co-locate and
continue to grow their presence and their market across Europe.
The original article was posted in the BIO conference day 2 updates. This can be found here - http://convention.bio.org/showdaily/Back to news