On 20 October 2020, “The Human Medicines (Amendment etc) (EU Exit) Regulations 2020” Bill was laid before the UK Parliament (the 2020 Bill). The Bill proposes amendments to various Statutory Instruments that were drafted in 2019 (the 2019 SIs) in anticipation of a “no-deal” Brexit. The 2019 SIs sought to enable the pharmaceutical regime in the UK to function independently of the EU, and for the MHRA to act as a stand-alone regulator of medicinal products placed on the UK market. The 2019 SIs have now been revived so that they are effective beyond the end of the transition period, which expires on 31 December 2020, subject to any agreement that may be reached with the EU about the ongoing relationship between the UK and EU.

The 2020 Bill includes a number of changes to the 2019 SIs, which themselves changed the current Human Medicines Regulations of 2012. However, one area that is of particular interest to the industry is the regulatory data protection (RDP), marketing protection and orphan exclusivity periods that apply to medicinal products authorised in the UK after the transition period. The 2020 Bill changes the position that had previously been set out in the 2019 SIs.

RDP period in the EU

Under EU legislation, originator products benefit from an eight-year period during which the clinical and non-clinical data provided in support of the marketing authorisation (MA) application may not be relied on by a generic applicant (RDP period), plus normally two years during which a generic product that may be authorised, may not be placed on the market (marketing protection period). The date from which any RDP period is calculated is the date of grant of the first MA for that active substance granted anywhere in the EU. This seeks to ensure a uniform period of protection throughout the EU.

RDP period under the 2019 SIs

The 2019 SIs provided that RDP for a UK MA would be calculated from the earlier of the UK MA or an MA granted in the EU. The effect of this was that if a company was granted an MA in the EU prior to the UK, the innovator MA holder would not benefit from the full period of protection for the UK MA. Calculating the date of first authorisation from the date of authorisation of an MA granted in the EU, rather than the date of authorisation in the UK, would also impact the term of Supplementary Protection Certificates and any paediatric extension for products placed on the market in the UK.

In addition, the 2019 SIs introduced the possibility of national authorisation of orphan medicinal products in the UK, which under the EU regime may only be authorised centrally by the European Commission. Under the 2019 SIs, the period of market exclusivity (i.e. ten years during which similar medicines for the same indication cannot be placed on the market) was calculated from the date of the EU authorisation, if that was earlier than in the UK.  Again, the result was a potentially reduced period of market exclusivity in the UK where the product was granted an earlier MA in the EU.

RDP under the 2020 Bill

While the UK has left the EU, under the requirements of the Northern Ireland Protocol, products placed on the market in Northern Ireland will continue to comply with the EU regime (so as to avoid a customs border with the Republic of Ireland).  As such, the MHRA needs to operate outside the EU regulatory framework in respect of Great Britain, but continue to regulate medicines in Northern Ireland largely on the basis of EU law.  The Bill tackles this by introducing three types of MA that may be granted by the MHRA, and that may be used as a reference medicinal product by generic applicants:

  • a UKMA(NI), valid in Northern Ireland
  • a UKMA(UK), valid in the United Kingdom of Great Britain and Northern Ireland
  • a UKMA(GB), valid in Great Britain (i.e. England, Scotland and Wales)

As regards UKMA(NI)s, RDP and orphan market exclusivity will be determined by the EU MA date in line with the current EU legislative regime. However, the 2020 Bill removes the general approach of “back dating” the start of the RDP period for a UKMA(GB) to the relevant date applicable in the EU. Instead, products authorised in Great Britain, under a UKMA(GB), will benefit from the full period of protection in Great Britain.  Under this regime, and as the Draft Explanatory Memorandum to the Bill recognises, there may be a “discrepancy in the period in which the medicine has [regulatory data] protection in different parts of the UK” if there is any delay between when a company receives an EU MA (which will be valid for the purposes of Northern Ireland), and when it receives a UKMA(GB).

Generic UKMA(UK)s will need to comply with the rules for both Great Britain and Northern Ireland MAs.  If the reference medicinal product used is a UKMA(GB) and a UKMA(NI), RDP must have expired in both Northern Ireland (i.e., in the EU) and in Great Britain. If the reference medicinal product to be used in the generic application is the subject of a UKMA(UK), the rule for Northern Ireland is followed and thus RDP must have expired in the EU.

As regards UKMA(GB)s, there are two instances in which the EU date will continue to apply for calculation of the expiry date in Great Britain. These are where the reference medicinal product chosen by the generic applicant is:

  • an EU authorised medicinal product for which the MA was valid at the end of the transition period, but was not converted to a GB MA because the holder of the EU MA opted out of the automatic conversion process; or
  • an EU authorised medicinal product for which the MA was no longer valid at the end of the transition period for reasons unrelated to safety, quality or efficacy.

However, such situations are likely to be limited.

Orphan exclusivity under the 2020 Bill

In relation to orphan products, applications for a UKMA(UK) for an orphan medicinal product will not be possible if there is an existing centralised orphan MA. As EU law will continue to apply in Northern Ireland, the centralised authorisation will be automatically applicable in Northern Ireland and EU orphan designation and protection will apply in Northern Ireland. In these circumstances, an applicant will be able to apply for a UKMA(GB) and would then be eligible for the full 10-year period of market exclusivity in Great Britain. In contrast to the position under the 2019 SIs, the 2020 Bill does not provide for any reduction of the 10-year period of market exclusivity for orphan products authorised in Great Britain, if a corresponding EU MA had been granted earlier. Again, this could mean that different market exclusivity periods would exist in parallel for the same orphan medicinal product placed on the market in Northern Ireland (linked to the EU date) and on the market in Great Britain.

The Bill is expected to become law by the end of the year, subject to amendments made during the debate process.