Taking any medical product across national borders nearly always presents an interesting dilemma or two, but while it’s sometimes horrible, it’s not always bad. Following is yet another example of the classic good news/bad news conversation, but the implications of each depend on where a device maker is selling its wares … or where it intends to go next.
MHRA Breezy on the Brexit
Device makers want to know how British regulators will manage things after the Brexit is an accomplished fact, but the “when” of the Brexit is still up for grabs. Recent reports suggest that Prime Minister Theresa May has agreed to a Brexit bill of €40 billion, but that figure might not be especially popular in some quarters in London.
By some accounts, the initial offer was roughly half that sum, but the €40 billion figure has nonetheless been making the rounds for several months. Antonio Tajani, President of the European Council, is quoted as having described the €20 billion offer as “peanuts,” but May has her hands full at home with members of Parliament (MPs) who would prefer to just walk away from the European Union and pay nothing for the privilege.
As if all this were not enough, there are new reports that May was “begging for help” with the Brexit in a dinner with the President of the European Commission. The story is all over the European press and does nothing to help May’s hand in dealing with intransigent MPs.
Meanwhile, the Medicines and Health Care Products Regulatory Agency has been busy, issuing a guidance on human factors engineering for devices as the third week of September drew to a close. MHRA followed that in short order with a document dealing with medical device stand-alone software, which includes apps. The MHRA stated in the latter document that its approach is based on the EU standard, Meddev 2.1/6, qualifying the British version as “the U.K.’s interpretation” of the EU guidance.
The details of the guidance are not unimportant, but what the MHRA leadership is clearly conveying is that it intends to run as close to parallel as it can with the EU approach to device regulation, at least so far as circumstances permit.
This might come as nothing new to MHRA watchers who probably noticed the paper the agency published toward the end of August for device regulations generally. That document did little more than spell out the requirements of the European Union’s MDRs, hence the software document reaffirms what was already suspected regarding MHRA’s intentions.
As for the human factors guidance, the document stated that its terms apply only to changes to existing approvals and to new applications, but MHRA advised that post-market surveillance will also be very much on its mind going forward. Among the entities said to have collaborated with the agency on this document is Eucomed, so clearly the agency consulted extensively with industry, particularly given that Smith & Nephew is also listed as a collaborator.
New Delhi’s device dilemma
Speaking of tense international relations, the Advanced Medical Technology Association has petitioned the Office of the U.S. Trade Representative to pull India off the list of nations that enjoy the benefits of the U.S. Generalized System of Preferences (GSP). AdvaMed filed the petition because of a recent string of mandatory price cuts for cardiology and orthopedic devices, but trade talks in Washington this week may include a discussion of that problem.
India’s drug pricing authority had applied a hard cap to prices for drug-eluting stents in February, and since then has moved to cap prices for some orthopedic implants as well. AdvaMed said the hit for coronary artery stents is as much as 85 percent in some instances, while some orthopedic devices would face cuts of 70 percent.
Abbott Vascular had attempted to pull its Xience Alpine stent from India, and initially, the government agreed. Despite that typically such withdrawals entail only a six-month transition, India’s National Pharmaceutical Pricing Authority required that the company keep the device on the market for a year.
As luck would have it, however, NPPA reversed that decision and has advised Abbott that it would have to keep supplies of the Alpine available indefinitely. There has been some indication of flexibility on the part of NPPA, which is said to have informally floated a less strangulating cap on trade margins recently, but AdvaMed seems likely to continue pressing its case. Those who tracked the string of Asian compulsory licensing episodes of the previous decade may see a similarly unfriendly shadow over these markets, particularly given hints that other nations in Asia may follow suit.
The governments of the U.S. and India will meet this week at the Trade Policy Forum in Washington, but it’s not just any meeting of the forum. This is a ministerial-level meeting, so the USTR will have all the brass it needs to make a high-level case that the NPPA’s moves are out of bounds. Device makers would do well to stay tuned to this story.