British Pharma Industry Faces Challenges Post-Brexit

Posted by Tom Penrice on Mon,Dec 12, 2016 @ 09:00 AM
The British pharmaceutical industry is facing new challenges following the UK’s decision to leave the European Union, a white paper has revealed. Published by Global Data, it warned of wide-reaching impacts.

The British pharmaceutical industry faces important challenges since the Brexit, with implications for drug development, grant funding, workforce movement.51% of Britain’s medicinal and pharmaceutical products are exported to the European Union (EU). But in June, a referendum indicated the UK should leave the EU – the so-called “Brexit”.

While Big Pharma companies emerged from the vote largely unscathed – some even enjoyed a small but immediate increase in their share prices – the result is likely to create challenges industry-wide, as a new white paper published by Global Data has forecast.

Question mark over drug regulation

Drug manufacturers will face an “immediate impact in the area of drug and medical device regulation,” explained Global Data in its paper.

The European Medicines Agency (EMA), which is responsible for the evaluation and monitoring of all drugs marketed in the EU, is currently headquartered in the UK. If it relocates to the EU when Brexit commences, companies may need to file for approval separately between the UK and the EU.

Then there is the EU Clinical Trials Directive. Although it is fully implemented into UK law, a new directive is expected to take effect in October 2018. Participation is necessary in order to gain drug approval within the EU.

Global Data warned that if the UK does not adopt the upcoming legislation, then the number of multi-center clinical trials in both the UK and EU is likely to be reduced, since “it will be very difficult and costly to integrate national trial authorization procedures with the new EU centralized trial authorizations”.

The issue of grant funding

Another big post-Brexit issue is funding and investment, as Britain’s The Telegraph reported. It explained that UK institutions and researchers receive a significant amount of European funding through grants, including Horizon 2020 and the European Investment Fund.

Up to £8.5 billion of funding and investment in UK science could be lost over the next four years, potentially isolating UK research and development and reducing its influence within the global scientific community.

In order to keep the money from these grants flowing, Britain needs to show why it is an attractive place to invest in life sciences, including pharmaceuticals and medical devices – a sector that accounts for more than 180,000 jobs and generates revenue of over $80 billion in the UK, according to UK Trade and Investment.

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, told The Telegraph: “We have a fantastic asset, which is the NHS, and a fantastic science base. We need to connect those two together so the industry can see that as well as investing in our science base at the early stage of research, we have the potential for those medications to flow through the system [into commercialisation].”

Restrictions limit pharma workforce

Meanwhile, there is uncertainty surrounding the pharmaceutical workforce. If restrictions are placed on freedom of movement within EU countries, this could limit the UK’s reach across Europe’s skilled workers.

A PWC blog explained that around 7% of the pharmaceutical and life sciences industries’ employees are non-British EU citizens, warning that many academics and senior pharmaceutical staff who frequently move around Europe could be affected.

Swiss pharma industry sets example

It is not yet known whether Britain will opt for a “hard Brexit” or “soft Brexit”, with the latter being less of a threat to biotech and science, according to Forbes. It is however expected that the EU will make the terms of Brexit as harsh as possible, the site reported, “with little protection for biotech or science”.

Luckily, it is not all doom and gloom. Global Data cited Switzerland as the leading example of successful pharma and medical devices industries outside of the EU.

The country boasts low effective corporate tax rates and flexible labor laws, allowing for more liberal contracts, longer working hours, and reduced union involvement. Perhaps following in Switzerland’s footsteps, British Prime Minister, Theresa May, recently pledged to deliver the lowest corporation tax rate in the G20.

Global Data concluded: “The solution might lie in creating a uniquely British solution. The European Economic Area (EEA) has already been cited by commentators as an alternative approach for the UK to maintain access to the Single Market, albeit at the cost of accepting freedom of movement between the EEA and EU.”

Pennside Partners has also expanded its European presence with a new UK office located south of Manchester. Find out more here.

Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Drug Development, Big Pharma, British Pharma Industry, Pharma UK, Pharma Europe, British Pharma

Is Maine Right About Importing Prescription Drugs?

Posted by Judi Space on Sat,Nov 23, 2013 @ 06:00 PM

Should Maine allow imported prescription drugs from Canada? FDA and other considerations.With the rising cost of health care, many US citizens are crossing into Canada to buy less expensive prescription drugs.   In fact, a group from Maine, consisting of state employees, Portland employees, and one large company, claims to have saved approximately $10 million over several years by purchasing their drugs through a Canadian mail-order pharmacy.  However, the legality of importing drugs into the US continues to be a gray area. 

Illegal for Individuals to Import Prescription Drugs?

According to the FDA

“In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States.”  However, the FDA typically allows for exceptions under the following circumstances: 

  • The pharmaceutical drug is for use for a serious condition for which effective treatment is not available in the United States;
  • There is no commercialization or promotion of the drug to U.S. residents;
  • The drug is considered not to represent an unreasonable risk;
  • The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and
  • Generally, not more than a 3-month supply of the drug is imported.


Act to Facilitate the Personal Importation of Prescription Drugs from International Mail-Order Pharmacies

In 2012, a former state attorney general in Maine decided to ban companies that were importing drugs from conducting licensed business in Maine.  This move was in response to a complaint from the Maine Board of Pharmacy that foreign pharmacies were not licensed under law. This ban stopped the savings some individuals in the business community and the state and local governments were receiving. 

In response to the ban, state senator, Troy Jackson introduced the “Act to Facilitate the Personal Importation of Prescription Drugs from International Mail-Order Pharmacies”   - an act that allows its residents to purchase prescription drugs from mail-order pharmacies in Canada, the UK, New Zealand, and Australia.  Maine’s state legislature overwhelmingly passed the act and the law went into effect on October 9, 2013. 

The Lawsuit - Big Pharma & Others Weigh In

The Pharmaceutical Research and Manufacturers of America, the Maine Pharmacy Association, Maine Society of Health-System Pharmacists, and others filed a lawsuit against the state of Maine, stating that the law circumvents “the carefully constructed closed federal regulatory structure governing prescription drugs and thus posing serious health risks to consumers.”  The lawsuit further argues, “Prescription drugs shipped to Maine by foreign pharmacies pursuant to the (law) are not subject to any of the quality and safety controls put in place by the federal government in order to protect persons who rely on prescription medications.”

This discussion is not over.  Currently, Maine is seeking dismissal of the lawsuit and the plaintiffs are requesting an Oral Argument. 

For the Act

Sharon Anglin Treat, National Legislative Association on Prescription Drug Prices, said, “This legislation will save money for Maine consumers, businesses, and local and state governments and provide access to high quality medications.  Prescription drug prices in the US are the highest in the developed world… Until such time that we join other countries in making drugs affordable, importation in the manner enacted by Maine Legislature makes eminent sense.”

Against the Act

Marv Shepherd,  Partnership for Safe Medicines, stated, “However well-intentioned Maine’s importation legislation may be, the health risks of counterfeit medicines far outweigh any cost savings.  The bottom line is that the FDA cannot guarantee the safety or efficacy of any prescription medication from outside the US supply chain, and when medicines are not FDA approved patients are put in danger.”

Implications are Clear

The consumer implications for prescription drugs in Maine and elsewhere are clearShould the lawsuit by PhRMA, et al, be unsuccessful, it will open the doors for easy access to lower priced brand name prescription drugs enjoyed by residents of other countries, at least in the state of Maine. Other groups seeking to save money on prescription drug costs may use this as an example and press for similar legislation in other states.

In states where the Pharma industry has less influence, and there is generally less support for industry protection in general, these bills are more likely to succeed.

Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Health Care Costs, Prescription Drug Costs, Prescription Drug Importing, Big Pharma

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