SPCs Can Be Granted In UK After Brexit Transition Period, Says Withdrawal Agreement
Executive Summary
If requests for supplementary protection certificates are filed in the UK during a Brexit transition period, and the grant procedure is still under way at the end of that period, the SPC can still be awarded under the provisions of the EU regulation, according to the draft withdrawal agreement.
The life science sector may not have much to cheer about on the Brexit front, but companies planning to apply for UK supplementary protection certificates for new medicines in the coming years will draw some comfort from a newly agreed section of the draft withdrawal agreement on the granting of SPCs in the UK after it leaves the EU.
In a June 19 joint statementon the progress of negotiations on the draft agreement since the last round of negotiations in March, EU and UK negotiators said they had reached agreement on a number of points, including Article 56, which deals with what happens to SPC applications that are filed in the UK during any transition period and are still being processed when that period expires (currently scheduled for the end of 2020).
The matter was brought up by the European Commission in an April notice&to stakeholders that said that “subject to any transitional arrangement that may be contained in a possible withdrawal agreement,” Regulation No 469/2009 on SPCs for medicines (and the corresponding regulation for plant protection products) will no longer apply to the UK after it withdraws from the EU on March 29, 2019. This raised the question of what would happen to pending SPC applications in the UK.
Article 56 of the draft agreement confirms that the provisions of the two regulations will apply to applications for SPCs (or for extensions thereof) that are submitted in the UK before the end of the transition period and where the administrative procedures for the granting of the SPCs are still ongoing at the end of that period. This means that such SPCs can still be awarded after the expiry of the transition period, and that they will offer the same level of protection as an SPC awarded in any EU country.
Warwick Smith, director general of the British Generic Manufacturers Association (BGMA) and the British Biosimilars Association, told the Pink Sheet: “We very much welcome the assurance that SPCs granted or filed in the UK during the transition period will be maintained beyond it. In order to maintain stability of supply, it is paramount manufacturers are given assurances over the next three years wherever possible. Nothing should be put in place which disrupts getting medicines to the right patient at the right time."
“More widely, following the end of the transition period or in the event of a no deal situation, we think that the UK government should maintain continuity around SPC start dates – to peg the UK start date against the date of the first marketing authorisation among EU member states and the UK – and to continue parity around the duration period," Smith commented. "This move will best support UK patients having early access to new medicines, the NHS [National Health Service] getting savings from the onset of generic and biosimilar competition after the SPC expiry as quickly as possible, and ensuring as much certainty for manufacturers as we can.”
Steve Bates, CEO of the UK BioIndustry Association, said it was "good to see progress in this area. Clarity that SPCs applied for before and during the transition period will continue to be treated as they are now provides useful continuity for industry." However, he added, "the fact that an SPC waiver proposal is currently under consideration and IP incentives more broadly remain under review in Brussels is an important context to note.” (Also see "EU SPC Waiver Move Puts Originator And Generic/Biosimilar Firms At Odds" - Pink Sheet, 29 May, 2018.)
The Association of the British Pharmaceutical Industry said the confirmation came "as companies continue to plan for the UK's exit from the EU." It noted that the government had made it clear that "cooperation on medicines is a priority and we urge both sides to come to an early agreement in the interest of patients and public health."
A marketing approval granted by the UK after the withdrawal date “will not be considered a first authorisation to place the product on the market” – European Commission
The commission’s April notice also stated that a marketing approval granted by the UK after the withdrawal date “will not be considered a first authorisation to place the product on the market” in the EU.
The "first authorization" concept is important for calculating the term of SPCs: they take effect at the time of patent expiry for a period equal to the time that elapsed between the date the patent application was lodged and the date of first marketing authorization in the EU, reduced by a period of five years.
While the clarification on SPC applications filed during the transition period will be welcomed by the life sciences sector, it has to be remembered that, as the commission has repeatedly pointed out, “nothing is agreed until everything is agreed.” There is still a long way to go in the withdrawal agreement negotiations, and it is far from clear whether a transition period will finally be agreed.
Timetable Slipping
The withdrawal greement will be discussed at the June 26 meeting of the EU’s General Affairs Council (Article 50), which will also examine the state of play regarding talks on the border between Ireland and Northern Ireland and the framework for the future UK-EU relationship, in preparation for the key European Council summit on June 28-29.
Presenting the joint statement on June 19, Michel Barnier, the commission's chief negotiator, said that the talks had “advanced on some separation issues for which European businesses need certainty, such as customs, VAT, Euratom and certificates for goods,” and that “engagement by the UK on remaining issues such as the protection of personal data and geographical indications is also to be welcomed.”
However, he cautioned that “serious divergences” remained on the Ireland/Northern Ireland issue, and said he would present the state of play of the negotiations to heads of state/government at the summit, as well as to the European Parliament.
“Today marks a step forward in these negotiations but a lot more work needs to be done before October," Barnier declared. October is when the final version of the withdrawal agreement and a political declaration on the framework for the future relationship are supposed to be agreed, although this timetable is looking increasingly in doubt.
The commission’s gloomy assessment was echoed in the draft Council conclusions for the summit, which said that the political declaration would also need “further clarity” from the UK. And in a statement that suggested a “no-deal” or "cliff-edge" Brexit could not be ruled out, the council said it “renews its call upon Member States and all stakeholders to step up their work on preparedness at all levels and for all outcomes.”
This article has been updated to include a comment from the BIA.
From the editors of Scrip Regulatory Affairs.