8+2+1 plus what? How UK data and market exclusivity rights will be affected from 1 January 2021

The highly regulated nature of the pharmaceutical sector makes compliance a significant cost, particularly when generating the clinical and non-clinical data needed to support a marketing authorisation. 

How can the investment in collecting this data be protected, and pharma encouraged to get their drugs on the market? The regulator's answer is to offer data exclusivity and market exclusivity rights against generic rivals. 

As the UK approaches a turning point in the Brexit process on 31 December 2020, let's look at how these important rights will be affected in the UK.

The current status of Brexit

Has Brexit actually happened already? Well, the Prime Minister's office insists it has (and some say No 10 has even banned the word!).

This is because the UK actually left the EU at 11pm on 31 January 2020. On this date the European Union (Withdrawal) Act 2018 (2018 Act) repealed the European Communities Act 1972, by which EU law ultimately takes effect in the UK. 

But, at the same time, the similarly titled European Union (Withdrawal Agreement) Act 2020 (2020 Act) implemented in UK law the Withdrawal Agreement – that is, Boris Johnson's "oven-ready deal" – agreed between the UK and EU, which includes the "Northern Ireland Protocol" amongst other matters. 

This "saved" much of EU law (including that relevant to patents and the regulation of life sciences products) so that it continues to apply in the UK until the end of an "Implementation Period". 

The Implementation Period ends at 11pm on 31 December 2020 and the application of the great majority of EU law in the UK ends with it, except to the extent that EU law is written into and is a part of UK law. For the immediate future, most UK law will look almost identical to EU law, except to the extent that references must be changed to reflect the UK's new status as a sovereign state.

As an example, references to regulatory agencies and to geographies will be limited to UK agencies and to the UK as a nation state. The UK legislation also has to deal with the complication of Northern Ireland remaining under EU rules rather than UK ones as a result of the Northern Ireland Protocol.

A quick refresher on EU Marketing Authorisations (MAs)

The rules on MAs and related data and market exclusivity will continue to apply under UK law after 31 December 2020, when they are transposed into UK law by the domestic Human Medicines Regulation 2012 (2012/1916) (as amended to allow them to function in a UK only context).

Assuming no mutual recognition agreement between the UK and the EU – which seems the most likely outcome at this late hour – the UK won't participate in the European system for granting MAs, of which there are three above and beyond a national-only authorisation:

• mutual recognition
• de-centralised, and
• centralised. 

The first two of these result in national-issued MAs.

Centralised MAs

Because centralised MAs are issued by the European Medicines Agency (EMA) and intended to be respected in every member state, these will have no effect in the UK after 1 January 2021. The Medicines and Healthcare Products Regulatory Agency (MHRA) has provided for current centralised authorisations to automatically convert into Great Britain (ie excluding Northern Ireland) and the MA holders will be issued with a new UK MA number on 1 January 2021. 

It is possible to opt-out of this conversion process by notifying the MHRA by 21 January 2021. The sunset provisions (requiring use within three years or the authorisation will lapse) will apply from 1 January 2021. These MA holders then have a year to provide the MHRA with any additional information required. MA holders without an established UK entity that is the UK MA holder have 24 months to establish an entity in the UK to which the MA will be transferred.

Centralised MA Applications in Process at 1 January 2021

After 31 December 2020, applications already made to the EMA but not yet authorised will be transferred to the MHRA. How much review the MHRA will undertake is dependent upon the stage at which the MA application has reached.

So, from 1 January 2021 all valid MAs in Great Britain will be solely national authorisations. The UK national system for authorisations is anticipated for the time being to mirror closely the EU application and authorisation process, as currently.

The effect of the Northern Ireland Protocol on MAs

The Protocol will take effect after 31 December 2020 and place Northern Ireland (NI) in the UK customs territory and, for the most part, under UK law. 

However, it also commits NI to align with certain EU regulatory laws on goods, including medicinal products. In particular, centralised MAs will continue to apply in NI, although they will be regulated by the MHRA. The Protocol does not apply to Great Britain (GB), however, which is free to diverge in these areas. 

What this means in practice is that it will be possible to obtain separate MAs within the UK: (UK)NI (compliant with EU law) and (UK)GB, as well as MAs for the UK as a whole. 

What will happen to the right to exclusivity for UK MAs?

Retaining the 8+2+1 system

Data and market exclusivity rights are based on and run from the authorisation of a new medicinal product (reference medicinal product).

Since 2005, applications made for the MA of generic medicinal products under the "abridged procedure" in EU law have been unable to refer to the reference medicinal product's data until eight years from the date the reference product was authorised (Article 10(1), first paragraph). This is the data exclusivity period. 

However, there is then another wait for a further two years before the market can actually be accessed by the generic medicinal product. This further two-year period means that there is actually a 10-year market exclusivity period after authorisation (8+2) (Article 10(1), second paragraph). 

An additional one-year period of marketing protection may also be available where a new therapeutic indication has been authorised. This completes the regime known as "8+2+1".

These periods will be retained under the Human Medicines Regulation 2012 (2012/1916), but to which MA should they refer and when do they start now more than one form of UK marketing authorisation is possible?

When does the exclusivity period start?

Converted authorisations will preserve their periods of data and market exclusivity (See Part 3, Human Medicines (Amendments etc) (EU Exit) Regulations 2019 (SI 2019/775). With new MA applications though, both for NI (or the EU) and for Great Britain, applicants will need to strategize to maximise their potential periods of exclusivity.

For Northern Ireland, the application of the Protocol means that regulatory data exclusivity will be determined by the date of:

• any centralised EU MA
• authorisations anywhere in the EEA, and
• (in time and as authorisations diverge) UK authorised products. 

Where the dates under points two and three are not aligned, we presume that the authorisation that is the earliest in time will be the relevant date for the reference medicinal product.

Outside of Northern Ireland, the key date for data and market exclusivity for the majority of medicinal products authorised in Great Britain will be linked to the UK MA.

When obtaining a UK-wide MA, the Northern Ireland requirements will apply rather than any purely national UK requirements, should there be a difference in reference product as between Great Britain and the EU.

Once we start to see applications for MAs in Great Britain that don't refer to EU reference medicinal products – and perhaps see products not being authorised in Great Britain but which are authorised in the EU – applicants for MAs in the UK will want to review the reference periods and determine whether for Great Britain they might obtain a longer period of exclusivity via a separate GB MA, or one that includes the whole of the UK and which would follow EU rules. 

8+2+1 plus a big question

Originally, the draft regulations transposing the data and market exclusivity rules into UK law provided that protection should run from the date of the EU reference medicinal product authorisation. This caused concern that companies placing drugs on the British market would potentially lose out if the British authorisation is later. After lobbying by the Association of British Pharmaceutical Industry and others, this was changed.

The big question is, now Great Britain (but not Northern Ireland) is free to diverge on data exclusivity periods, will they, and how? Will they be extended, or shortened, or changed more radically? There is a debate to come on this when the Brexit dust has settled, and no doubt litigation will ensue.

Find out more

To discuss any of the issues raised in this article in more detail, please contact a member of our Life Sciences & Healthcare team.