Legal Status of Mutually Recognised Authorisation after Brexit

A Mutually Recognised Authorisation: What will be
its legal status when UK leaves the EU where the
UK is the Reference Member State
By
This project is submitted in part fulfillment of the QQI/NUI requirements for the award of
Master of Science in Medical Technology Regulatory Affairs.
29 July, 2019

Declaration
Title: A Mutually Recognised Authorisation: What will be its legal status when UK leaves
the EU where the UK is the Reference Member State
Name: ___________
ID Number: _____________
Academic supervisor: _____________
Declaration: “I hereby declare that this project is entirely my own work and that it has not
been submitted for any other academic award, or part thereof, at this or any other
education establishment”.

Table of Content
Contents
Literature Review....................................................................................................... 4
Principles and legal basis........................................................................................ 4
Article 50 process steps....................................................................................... 4
European Union regulatory system for medicines................................................8
The pharmaceutical sector...................................................................................... 9
Impact of No Deal.................................................................................................. 11
The meaning of WTO's PTEA................................................................................. 16
Methodology............................................................................................................. 18
Limitations............................................................................................................. 18
Pre-Brexit Figures.................................................................................................. 18
Drug pricing and reimbursement..........................................................................20
Biosimilar drugs..................................................................................................... 20
Clinical trials.......................................................................................................... 21
Effect of Brexit on the pharmaceutical industry – Post-Brexit...............................21
Diminished innovation........................................................................................... 22
Losing its status of global research leader............................................................23
Decreasing R&D spending.................................................................................. 23
Recommendations.................................................................................................... 25
Negotiating 'associated country' status in research funding programs of the EU. 25
Negotiating bilaterally favorable agreements for drugs and medical devices.......26
Assurance of free movement of skilled professionals............................................26
References............................................................................................................... 29

Literature Review
Principles and legal basis
In order to evaluate the regulatory aspects of Brexit, it is required that some of the basic facts
should recalled related with Art 50, Treaty on the EU process steps, the "Withdrawal Bill of the
EU" and the legal framework related with medicinal products.
Article 50 process steps:
The UK held a referendum on 23rd of June, 2016. The issue was if the United Kingdom should
remain a part of the European Union. It's a modest majority of 51.89% of the voting was in favor
of leaving the EU. On 29 March 2017, a notification was given by the United Kingdom to the
European Council. In this notification, it had revealed its intention of leaving the European
Union and thereby formally triggering Article 50, Treaty of the EU, which provides a chance to
the member states to voluntarily withdraw from the European Union. Article 50 provides the
process that needs to be followed by a member states for leaving the European Union according
to its own constitutional requirements (Surviving Brexit, 2016).
Once it has been triggered, Article 50 provides a period of two years for negotiating the two
agreements. The first agreement is the withdrawal agreement GT related with details of the exit.
The second agreement is a distinct framework agreement, which takes into account the
framework of future relationship of the member states with the European Union required to be
done in accordance with Article 218, Treaty On The Functioning of EU (TFEU). It provides the
details regarding how the negotiations need to be opened and concluded. It also regulates the

conclusion of international agreements by the European Union (Thompson, Williams,
Ellingworth and Bates , 2017).
The withdrawal agreement is going to cover the immediate issues like the rights of the residents
of the EU who are living in the UK and similarly the privileges of the UK residents who are
living in the European Union, the financial commitments undertaken by the UK as a Member
Nation, border issue's and the seat of EMA, as well as the other agencies and the international
commitments that have been undertaken by the United Kingdom as a member nation of the EU.
As mentioned by Article 50, the final withdrawal and is required to be ratified by the United
Kingdom and it should also be approved by the EU Parliament along with at least 20, out of 27
member states who are represented in the EU Council by qualified majority (Anekwe, 2015).
The agreement related with future framework has to describe the conditions concerning
collaboration on a vast range of subjects. For example, it includes the level of access of the UK
to the single market in terms of goods, people and services. Moreover, the requirements related
with financial contributions, influence over the rules and regulations of the EU and adherence to
the laws of the European Union are also some of the issues that are going to be a part of this
agreement. Consequently, keeping in view the pharmaceutical regulatory and pharmaceutical
industry, a major section is going to be the agreement providing the basis for trade in future and
the framework for cooperation concerning certain objects of regulation (Galsworthy and
Davidson, 2015). The agreement related with future framework is also going to need
unanimous support from the members of the council and simple majority in the European
Parliament. In the same way, it also needs the approval of all the member states. Then this
agreement should be ratified by all the rest of the 27 member states and also the government of
the United Kingdom (Bradshaw, 2016).

As a result of the wide range of legal, political and economic links that are present among the EU
and the UK, a deadline of two years for concluding the exit agreement appears to be nearly
impossible. This position is further corroborated by a glance at the real negotiation practice. For
example, the negotiations that took place between Canada and the European Union concerning
the CETA Treaty had lasted for eight years and they have not still being ratified by the national
parliaments. In the same way, Switzerland and the European Union required five years for the
first tranche having more than 120 individual agreements.
It is also worth mentioning at this point that in case no deal concerning Article 50(2) sentence 1
TEU can be arrived at within the period of two years, in such a case, two options are available.
The first option is that the period for negotiations can be extended through an unanimous
agreement among European Council and the retreating member nation. The other option is that
the UK leaves the EU without including any withdrawal agreement. The result will be that the
duties of the European Union will cease to apply in case of the United Kingdom and there will be
no arrangement for managing this transition. Therefore it is clear that the second option is going
to result in considerable uncertainty. For many people, for example, the citizens of the United
Kingdom who are living in the European Union or the businesses of the UK, who are trading
with the European Union states and also for the UK organizations that depend on funds from the
European Union. Therefore, for example, if the parties did not reach at a trade relations
agreement, the country will be required to transact with the European Union in accordance with
the rules of the WTO. A transitional agreement will be almost necessary for making sure that the
businesses contribute in the trade that takes place with the European Union. It will also allow the
negotiations to be held in a less pressurized environment, which will be beneficial for all the
parties concerned. Article 50(3) TEU provides in this regard that of formal renewal of the