As of the date of the withdrawal of the UK from the EU, active substances manufactured in the UK will be considered “imported” active substances and other headaches

The European Medicines Agency issued a Q&A to address some Brexit issues that will directly impact US sponsors/manufacturers.

The EMA offers no specific guidance on the transfer and/or handling of clinical trials that are ongoing on the date that the UK leaves the EU, but the guidance does give us an idea of how complicated this is all going to be. Nota bene the issue caused by having one’s Qualified Person in the UK (which is 98% of US manufacturers, followed only by QPs in Ireland). We will continue to follow the EU’s guidance and will craft our EU contracts in such as way as to make the transfer as painless as possible.

OIG Issues 2016 Final Rule Expanding Anti-Kickback Statute Safe Harbors; Excludes Pharmaceutical Manufacturers From Most Of Them

Our read of 81 Fed. Reg. 88368 (December 7, 2016), issued by U.S. Department of Health and Human Services’ Office of Inspector General (OIG), does not appear to affect pharmaceutical manufacturers in any substantive way; our obligations are unchanged and no additional “safe harbors” are afforded.

The OIG did make a technical correction to the safe harbor for referral services, which we believe requires an update to the “anti-kickback and fair market value” clauses in our clients’ templates. We’ll be using the italicized text below, from this point on:

Vendor represents and warrants that neither Vendor nor any individual or entity acting on Vendor’s behalf, nor any payee under this Agreement, will, directly or indirectly, offer, pay or accept, or authorize the offering, payment, or acceptance of, any money or anything of value to or from any third party, with the knowledge or intent that the payment, promise or gift, in whole or in part, will be made in order to improperly influence an act or decision that will assist Vendor, the Sponsor or the third party in securing an improper advantage or in improperly obtaining or retaining business or in improperly directing business to any person or entity.

Further, the parties acknowledge and agree that the amounts payable by Sponsor or Sponsor’s designee under this Agreement represent the fair market value of the covered costs associated with the Services and no part of any consideration paid hereunder is a prohibited payment for the recommending or arranging for the referral of business otherwise generated by either party for the other party or the ordering of items or services; nor are the payments intended to induce illegal referrals of business.