News & Press
Edition 2 / December 2018
Article > Brexit: Support for Pharma in Uncertain Times
Edition 2 / December 2018
Author
Dr. John Cameron
Associate Director, Sales & Key Account Management
CordenPharma International
EU & UK Flags working together for Brexit.
Uncertainty Remains
With less than 4 months remaining before the UK is scheduled to leave the EU in what is commonly referred to as “Brexit”, concerns are increasing within the pharmaceutical industry about the consequences of the UK and EU failing to agree on terms of departure. This so-called hard exit or no-deal scenario, which would come into effect on March 29, 2019, would place patients and the pharmaceutical industry in the UK and across Europe in an unenviable state of uncertainty.
CordenPharma, with an integrated network of 7 GMP sites in mainland Europe and 2 in the US organized around 5 Technology Platforms, is geographically well placed to deal with this uncertainty and to help customers throughout Europe with continuity of supply.
Potential Pitfalls
EMA – In November 2017 the European Medicines Agency (EMA), which regulates the access of medicines to EU member states, made the decision to move its London Headquarters to Amsterdam (NL), with the potential loss of ~900 UK jobs. Despite this set back, the UK government’s preferred option is to remain part of the EMA, with Prime Minister Theresa May wishing that products only undergo one set of approvals. If this doesn’t happen, getting new medicines to patients will become more costly and slow. This has resulted in several of our UK customers asking for increased production and stockpiling medicines to negate this eventuality.
Labour Market – The UK pharmaceutical industry directly employs 73,000 people, with about 10% of them coming from the mainland EU. If the UK changes its immigration policy, it would become a less attractive place to secure top talent in this highly competitive sector. Reciprocal changes in EU policy could cause similar problems for British nationals working in the EU. This would obviously have unwanted ramifications throughout the Pharmaceutical and CDMO industry.
Free Trade – According to the UK Government’s analysis in 2016, £24.9 billion of pharmaceutical products were exported from the UK, almost half of which went to EU, benefitting 446 million potential patients. In the same period the UK imported £24.8 billion of pharmaceutical products, of which almost 75% came from the EU. Maintenance of frictionless borders and tariff free barriers are high on the wish list for most European businesses. The import and export of pharmaceutical products need to be tested and certified by qualified staff working for licensed companies that are recognised by the relevant national health authorities. Currently, a test in the UK is valid in the EU and vice versa due to a Mutual Recognition Agreement (MRA). The concern, at least up until September 2018, was a reversal of this process, with widespread consequences in the industry. The UK government recently, however, issued guidelines which will give UK Pharmaceutical companies at least some breathing space. They have agreed to accept batch testing of marketed products and Investigational Medicinal Products (IMPs) that are manufactured in EU and EEA (Norway, Lichtenstein & Iceland) states, essentially prolonging the MRA until “further change is necessary.” CordenPharma welcomes this development and hopes that the MRA, in some shape or form, remains in place come April, 2019.
CordenPharma has 9 GMP sites across Europe and the US, and although none of these are in the UK, it does have customers who must import and export to and from the UK. CordenPharma remains willing and able to help UK and other European countries during this challenging period. This could include supporting increased inventory of APIs, finished Drug Products, Pharma Packaging & Logistic services, and enhanced Analytical /QP Release, as well as aid in navigating the complexities of ever-changing regulatory authorities, if this need should arise.
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#CordenPharmaBergamo
Celebrations included a garden party with German-themed breakfast, lunch or dinner buffets, 15 Year custom cakes and gifts distributed to all employees, along with a speech from Managing Director Luca Porcu and VP of Platform Management & Marketing Stephen Houldsworth.
#CordenPharmaSwitzerland
Celebrations included an introduction of our core values, followed by playful games to implement them, distribution of 15 year bags, food and a live band in a garden party. Employees heard from Managing Director Dr. Juerg Burger and VP of Human Resources Stefanie Gerber.
#CordenPharmaPlankstadt
Celebrations were split into 3 groups to cover all shifts and included a festive room with a 3 course buffet meal, 15 Year custom gift bags with locally-brewed beer, and a welcome speech by Site Business Development Christina Simons and CEO Dr. Michael Quirmbach.
#CordenPharmaFrankfurt
Celebrations included a garden party with food trucks, table games, a pub quiz with team prizes, instant cameras for a photo collage, and 15 Year gifts. Guests included the CPI Global Compliance Team, Allessa GmbH, Weylchem Innotec GmbH, and Walter Krebs GmbH, with speeches by Head of Operations Dr. Karsten Meyenberg and CFO Heiko Serwe.
#CordenPharmaChenôve
Celebrations included a garden party with a “Burgundy” aperitif dinner, food trucks for lunch, a fun photo booth for taking 15 Year souvenirs, and speeches by Managing Director Yves Michon and CordenPharma Chief Quality & Compliance Officer Will Cashin.
#CordenPharmaCaponago
Celebrations continued 4 times throughout the day & night to cover all shifts, and included a multi-course German lunch or dinner with brezel, speeches by Managing Director Fabrizio Fiordigiglio and VP of Sales Dr. Mimoun Ayoub, followed by a festive garden gazebo for the 15 Year gift distribution of Prosecco and backpacks.
#CordenPharmaBrussels
Celebrations included a boat ride to Brussels City Center, followed by 3 groups taking guided bike or walking tours of secret places along the canal or the Tour & Taxis building. The party finished with a BBQ dinner and speeches from Managing Director Dr. Jean-Luc Dewez and VP General Counsel Nicolas Reischer.
#CordenPharmaBoulder #CordenPharmaColorado
Celebrations included a garden party with a festive banquet of foods from Italy, Germany, France, & US, games, marshmallow roasting, custom beer steins and other 15 Year gifts, and balloons stuffed with prizes. All employees then heard a speech from Managing Director Brian McCudden and COO Dr. Lee Newton.
Brittany Hayes joined CordenPharma as Director, Global Highly Potent & Oncology Platform in October 2021, bringing over 20 years of extensive experience in the areas of contract manufacturing (Drug Substance & Drug Product), pharmaceutical and API development, business development, contract management, and organic chemistry.
Prior to joining CordenPharma, Brittany held leadership positions at various Contract Development & Manufacturing Organizations (CDMOs) including Recro, Regis Technologies, DSM/Patheon/Thermo Fisher, Formex, Ricerca, and Azopharma. Most recently, Brittany was Applied Technology Director at Recro, where she was responsible for managing the proposal evaluations and development team, providing technical support to the BD team, creating training for new service offerings, and enhancing new client onboarding & knowledge transfer by liaising with business development executives, technical operations personnel, and project managers. Brittany excels at driving technical decision-making for successful pharmaceutical product development.
Brittany earned her Ph.D. in organic chemistry from Wake Forest University (Winston-Salem, NC) and her B.S. degree in Chemistry from Emory University (Atlanta, GA). She also was an American Heart Association postdoctoral fellow at the University of Illinois at Chicago, Department of Medicinal Chemistry & Pharmacognosy. Brittany has been an active member of the American Chemical Society since 1995.