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15 December 2020Big PharmaSally Shorthose and Rumana Khanom

What 2020 means for the life sciences

2020 has been a tumultuous year in many respects and the conflation of a pandemic and the impact of the UK’s departure from the EU has profound implications for the life sciences and medical devices industries in the UK and the EU. In this article, we consider how and why these events will have such an effect and how affected businesses may need to prepare for these.

Brexit implications

At 11pm on December 31, 2020, the Brexit transition period will come to an end. At this point, the UK will no longer be required to comply with EU rules and regulations and will no longer be part of the single market and the customs union. In due course, divergence from EU regulations is anticipated, although the extent of such divergence has yet to be seen and continues to be a source of controversy.

Some would like the UK to continue to align itself to the EU standards to facilitate trade with the EU, while others see opportunities to differentiate the UK from the EU. One area where we are already witnessing the beginning of this divergence is in the field of medical devices and medicines.

In 2021, and the UK and the EU will be operating sperate product approval and regulation systems. In September earlier this year, the UK Medicine and Healthcare products Regulatory Agency (MHRA) published guidelines on what businesses operating in these fields can expect. To provide a flavour, here are some of the highlights which will take effect from January 1, 2021.

Medicines

The MHRA will, for the UK, take responsibility for all decisions and functions which were previously handled by the European Medicines Agency (EMA). There is one main exception to this—the EMA will continue to take responsibility for decisions over applications for marketing authorisations (MA) made via the EMA procedure for the purpose of marketing medicines in Northern Ireland.

All centrally authorised EMA MAs which exist at January 1, 2021, for the purposes of supply of medicines to Great Britain (excluding Northern Ireland), will automatically convert to UK MAs. Existing EU MAs which have been centrally authorised will remain valid for the marketing of medicinal products to Northern Ireland.

Medical devices

Once the transition period comes to an end, the UK Medical Devices Regulations 2002, as amended and in the form in which they exist on January 1, 2021 (UK MDR 2002), will remain the key legislation applicable to medical devices in Great Britain (Northern Ireland will have closer links to the regulations).

The UK MDR 2002 will not include the amendments that would have been introduced by the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), which will be fully implemented only in May 2021, post the end of the transition period. For the purposes of medical devices in Great Britain, the UK MDR 2002 will be supplemented by the Medicines and Medical Devices Bill which is currently being debated in the UK parliament.

Manufacturers wishing to place a medical device on the UK market will need to register with the MHRA. Manufacturers based outside the UK will need to designate a ‘responsible person’ based in the UK to register and act on its behalf; hitherto only one responsible person would have been required for the whole of the EU, including the UK.

“Manufacturers based outside the UK will need to designate a ‘responsible person’ based in the UK to register and act on its behalf.”

The effects of Brexit on the life sciences sector are likely to be substantial. This is because, as a third party to the EU, the UK will no longer have access to many of the benefits of the EU system, such as the centralised procedure for MAs, the EU portal for clinical trials, and the Pharmacovigilance database (EudraVigilance). At the same time, the EMA will lose the considerable expertise at the MHRA, the UK clinical trials data, and the pharmacovigilance data on a population of 65 million.

For further guidance on the implications of Brexit on the life sciences sector, please read here.

COVID-19 implications

National authorities issued guidance on “emergency registration” for certain medical devices (MDs) and in vitro diagnostics (IVDs) for COVID-19. The exemptions contained in regulations 12(5) of the MDR 2002 (for MDs) and 39(2) of IVDR (for IVDs) are the main regulatory source which the UK is able to rely upon in order to provide increased regulatory flexibility for the approval of MDs and IVDs during the pandemic. All COVID-19-related queries are being prioritised ahead of standard targets.

There have been announcements relating to the development of vaccines from three companies so far—AstraZeneca (developed in conjunction with Oxford University), Moderna, and Pfizer (developed in conjunction with the German company, BioNTech).

On December 2, the MHRA approved the Pfizer/BioNTech vaccine for use in the UK—the first regulator in the world to do this. While some comments were made about the MHRA reaching its conclusions so quickly, the UK would always have been able to reach this solution while still subject to EU law. The centralised procedure whereby MAs had to be applied for via the EMA does not apply to some products, including vaccines. The speed with which the decision was reached may, however, indicate that the UK will in future be able to approve medicinal products for use more quickly than the EMA, but this is speculation.

Vaccines: Oxford AstraZeneca

AstraZeneca’s clinical trials of AZD1222 in the UK and Brazil showed a COVID-19 vaccine as highly effective in preventing serious disease, with no hospitalisations or severe cases of the disease reported in participants receiving the vaccine. More information on the dosing regimen can be found here.

An independent United Kingdom Data Safety Monitoring Board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine.

AstraZeneca will now immediately prepare regulatory submission of the data to authorities around the world that have a framework in place for conditional or early approval. The company will seek an emergency use listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries. There has been some concern about the way that AstraZeneca merged two sets of results, one showing 62% efficacy, the other 90% efficacy, to extrapolate an overall 70% efficacy.

The vaccine will be available on a non-profit basis to low and middle-income countries in the developing world. Unlike the vaccine produced by Pfizer/BioNTech, which requires ultra-cold storage (-80⁰C) during transport and storage, the AstraZeneca vaccine can be kept in the type of conventional fridges used to store vaccines around the world, with a shelf life of up to six months.

Unlike the Pfizer vaccine, AstraZeneca’s experimental vaccine is already a part of Covax, the global initiative that is hoping to distribute about two billion doses to 92 low and-middle-income countries at a maximum cost of $3 a dose. This is so any vaccine would not be hoarded by the world’s wealthiest countries.

Vaccines: Pfizer/BioNTech

Pfizer and BioNTech have concluded the final efficacy analysis in their ongoing Phase 3 study and have announced their COVID-19 vaccine candidate, BNT162b2, which uses innovative messenger RNA (mRNA) technology, as meeting all of the study’s primary efficacy endpoints. The vaccine indicates an effectiveness of 95%, consistent across age, gender, race, and ethnicity demographics.

Pfizer confirmed on November 20, 2020 it would go within days to regulators around the world for emergency authorisation based on its final data and manufacturing quality data. Pfizer and BioNTech have undertaken to deliver 50 million doses of the vaccine this year, with up to 1.3 billion doses next year. The UK has pre-ordered 40 million doses and has already received its first doses, now that the MHRA has approved its use in the UK (as mentioned above). The EU has ordered 200 million doses while the US has ordered 100 million doses.

Although Pfizer’s chief executive officer assured consumers on 23 November 2020 that the vaccine will be free for all US citizens, it appears the wholesale price negotiated in the US government contract is $20 per dose. The ‘free’ vaccine referred to was probably the first 100 million doses pre-ordered by the US government. The vaccine requires two doses, given three weeks apart.

Vaccines: Moderna

On November 30, 2020, Moderna announced a primary efficacy analysis in its Phase 3 COVE Study for its COVID-19 vaccine candidate and filed with the US Food and Drug Administration for emergency use authorisation. Moderna’s vaccine can be kept in an ordinary fridge at 2 to 8⁰C for a month and it was pitching at $37 a dose for developed countries, which is higher than Pfizer’s, but there has been speculation that in due course Moderna may have a cheaper pricing strategy for other parts of the world.

Like Pfizer’s, Moderna’s vaccine relies on a novel technology that uses mRNA to code for a ‘spike’ protein that studs the surface of the coronavirus. The company hopes to provide the US government with 20 million doses by the end of the year. The vaccine requires two doses, four weeks apart.

Delay in vaccine due to Brexit

After the end of the transition period, there may well be disruption at the UK border when the UK leaves the single market and customs union, as (for example) the Pfizer vaccine is manufactured in Belgium and will need to be imported into the UK.

Although the UK government has stated it is launching a task force to avoid disruptions at borders, this area is likely to be continuously changing in the next couple of months, with initial confusion and delays as customs and hauliers alike come to terms with new paperwork and systems.

Summary

The future offers uncertainty and perhaps opportunities in the light of Brexit, and the success of pharma companies in coming up with successful anti-COVID-19 vaccines has, notwithstanding the remaining detractors, done a lot to overturn the largely negative perception a portion of the general public have had of “big pharma” over the last few years.

Sally Shorthose is a partner and head of life sciences regulatory at Bird & Bird. She can be contacted at:  sally.shorthose@twobirds.com

Rumana Khanom is a trainee solicitor at Bird & Bird. She can be contacted at:  rumana.khanom@twobirds.com


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More on this story

Asia
1 September 2020   As AI becomes a crucial weapon in the battle against the global pandemic, companies in the field need to ensure that their valuable IP is protected, as Mao Xiao Hong and Danny Yap of IPOS International explain.
Big Pharma
10 October 2017   If the UK government changes the rules for clinical trials after Brexit, the regimes in the UK and the EU will diverge and possibly make trials more complex and costly, as Rachel Bradley of Penningtons Manches reports.