Emma Beausang, PhD

	By a narrow majority, the U.K. voted in June 2016 to leave the European Union. Under Prime Minister Theresa May, the U.K. government indicated that by the end of March 2017 it would  trigger Article 50 - the legal instrument by which a member state begins the process of withdrawing from the Union.
	
	In the aftermath of the referendum, the likelihood of Brexit taking a “hard” or “soft” profile was debated at length. A “hard” Brexit, synonymous with the U.K. leaving the EU single market in order to restrict the free movement of people, was finally confirmed in a speech made by the prime minister on Jan. 17. A government white paper followed in early February, laying out priority areas and goals for the two-year period of negotiation that will follow once Article 50 is triggered. Brexit’s  wide-ranging potential effects on the pharmaceutical industry, discussed in an earlier 

, will be examined again in this article in light of information presented in the white paper.

Legal Basis for Drug Regulation/Licensing


	
	With the Great Repeal Bill, all existing EU-level legislation will be converted into domestic U.K. law in order that the same rules and laws will apply immediately following a U.K. exit from the EU. In theory, this provides reassurance that regulation will not change overnight; however, the status of the European Medicines Agency as regulator and U.K.’s role with respect to the EMA remains unclear. The pharma industry has warned government that withdrawing from membership in the EMA may precipitate delays in new drugs being approved with U.K. waiting in line with Canada and Australia while the industry focuses initially on the larger U.S. and EU markets.
	
	


	
	Notwithstanding the above, the government makes clear its intention to remove jurisdiction of the European Union Court of Justice from U.K. law. As EMA is subject to EUCJ, the departure of the EMA from the U.K. seems inevitable. As many as 20 member states are in apparent competition to host a post-Brexit EMA at last count. The uncertainty surrounding the agency’s future has already manifested in an exodus of senior talent, difficulties in recruitment and low morale, according to Guido Rasi, executive director of the EMA, in an interview given in January 2017.


	
	With the government committing to control immigration from EU member states, the pharmaceutical industry will no longer have unlimited access to a mobile workforce following U.K.’s departure. Securing the rights of EU nationals currently residing in the U.K., as well as U.K. nationals resident in EU member states, has been highlighted as a priority. However, in the future, some level of qualification must surely be foreseen before newly arrived EU nationals are permitted to be employed in the U.K.
	
	


	
	With a commitment to control EU migration, the government has unsurprisingly confirmed its intention to leave the single market and aims to renegotiate the “freest possible trade in goods and services between the U.K. and the EU.”

 The U.K. will have to rely on goodwill and perceived common sense from remaining EU member states given the risk that those left behind may wish to punish the U.K. for daring to abandon the European ideal.
	
	A withdrawal from the EU single market will also require new trade deals to be brokered with third countries. The long-term effect of this trade uncertainty on the U.K. pharmaceutical industry, as part of the U.K. economy, is not yet known. In the nine months since the referendum result, the sterling has devalued against the U.S. dollar by approximately 16 percent. The FTSE 100 index has risen on aggregate to sit almost 1,000 points higher than the day before the result.
	
	

Preserving Science and Innovation Excellence


	
	The government aims to preserve the U.K. as one of the best places in the world for science and innovation, recognizing the reputations of U.K. universities and associated scientific and academic communities. Researchers are encouraged to continue to apply for EU funding, e.g., Horizon 2020, with any award being underwritten by the U.K. government if necessary following departure from the EU. Despite government reassurance, universities may be concerned about a potential reduction in applications from foreign students and the consequent loss in fees. Additionally, there may be fewer experienced foreign academics wishing to work in the U.K. sector.
	
	

A Hope for Clarification During Negotiations


	
	Although the government white paper serves to clarify key questions such as the intent to control EU migration and leave the EU single market, many questions remain as to the specifics of pharmaceutical regulation following the U.K.’s exit from the EU.
	
	The industry, through groups such as the EU Life Sciences Steering Group and Public Policy Projects, continues to be vocal in its lobbying of the government to thoroughly assess the potential impact the separation may cause and to focus on the details of an exit.

 However, the relationship with the EMA, the role of the Medicines and Healthcare products Regulatory Agency, and the future process by which new medicines will be approved for use in the U.K. and monitored for safety are all as yet unknown.
	
	With formal separation proceedings to begin by the end of March 2017, a two-year period of negotiations will soon begin. The pharmaceutical industry can only hope the significant uncertainties will be clarified early in negotiations to enable proactive planning ahead of a U.K. exit from the EU, now expected in March 2019.
	
	

, MRPharmS, Director, Regulatory Affairs, Chiltern
	
	

		“The United Kingdom’s Exit From and New Partnership With the European Union,” Prime Minister Theresa May, February 2017. 

https://www.gov.uk/government/uploads/system/uploads/attachment		_data/file/589191/The_United_Kingdoms_exit_from_and_partnership_with_		the_EU_Web.pdf

		“London-based Regulator for EU Drugs Fears Staff Exodus,” London Times. 

https://www.ft.com/content/2ca416ba-c8f8-11e6-8f29-9445cac8966f

		“Maintaining and Growing the U.K.’s World-Leading Life Sciences Sector in the Context of Leaving the EU,” U.K. EU Life Sciences Transition Programme Report for the U.K. EU Life Sciences Steering Committee, Sept. 6, 2016. 

http://www.abpi.org.uk/our-work/library/industry/Documents/UK-EU-Steering-Group-Report.pdf

		“Finding a Cure,” Report by Public Policy Projects, QuintilesMS. 

http://www.publicpolicyprojects.com/wp-content/uploads/sites/4/2016/11/PPP-QuintilesIMS-Finding-a-cure-report.pdf

Articles

With the U.K. poised to begin the process of leaving the European Union soon, many questions remain as to the specifics of pharma regulation and the wide-ranging effects of this departure.

Where’s the Exit? An Update on Brexit

	On June 23, a narrow majority voted in a referendum for the United Kingdom to leave the European Union (52% vs. 48%). With no member country having exited since the EU’s creation in the 1990s, this decision is unprecedented, resulting in uncertainty and speculation as industry attempts to understand its full implications. The UK’s new prime minister, Theresa May, hastily elected after the resignation of David Cameron, came into office proclaiming that “Brexit means Brexit.” 

	Clearly, continued market uncertainty may impact the health of industry in the UK. However, beyond any general economic considerations, what might the new reality facing the country and the European community be, and, how will the changes impact the pharmaceutical and life sciences industry? 

	The UK life sciences industry contributes more than £50 billion to the UK economy, and with approximately one-eighth of the world’s most popular prescription medicines being developed in the UK, the industry has a reputation as a world leader in research and innovation.

 As far as most in the industry are concerned, both UK-based and beyond, the status quo of UK membership in the EU “works.”

	The UK pharma industry enjoys many benefits through the country’s existing EU membership. The UK is recognized internationally as a center for research excellence, and, as a EU member, has had access to high levels of EU funding for research, development and innovation. Over the period 2007-2013, the UK received roughly 8 percent of the total research funds available, amounting to €8.8 billion and the fourth highest funding allocation across eligible countries. The current budget for EU research funding over the period 2014-2020 is €120 billion.

	In addition, the UK pharma industry has access to a large workforce with all EU nationals possessing the right to work in the UK without needing a work permit or visa. In the first quarter of 2016, approximately 7 percent of the total working population in the UK were expatriate EU nationals.

	The European Medicines Agency (EMA), the central regulatory body for the EU, is housed in Canary Wharf in London where almost 900 staff carry out the agency’s business, leveraging scientific expertise from EU national regulatory agencies to evaluate medicinal products, provide scientific advice and monitor the safety of medicines across the EU. The current arrangement for review and approval of medicines’ licensing applications also allows reciprocal benefits regarding the access to medicines in the UK. 

	Additionally, pharma companies may obtain marketing approval in the UK at the same time as other EU member states while, in turn, the UK population may access all medicines approved either centrally by the EMA or through a decentralized procedure involving the UK. Likewise, the safety monitoring of medicines in the UK is closely linked to EU-level pharmacovigilance legislation and EMA initiatives. Finally, the review and approval steps required in advance of conducting a clinical trial in the UK are consistent with all other EU member states. 

	In short, the regulation of medicines in the UK is enmeshed in the EU-level platform to a significant extent. For many, the prospect of unpicking the UK from the current arrangements following an EU exit is daunting to say the least.

	Although some initial opinions suggested the referendum result might be advisory, the UK government has insisted the mandate will be respected and an exit is inevitable. However, the mechanics of a UK exit from the EU are far from clear and the implications of several possible models warrant consideration.

	The European Economic Area (EEA), established in 1994, extends the EU’s internal market to include Norway, Iceland and Liechtenstein (non-EU countries). Although EEA countries are not members of the EU, EU legislation relating to the internal market - governing the “four freedoms” of goods, people, services and capital - becomes part of the legislation in EEA countries once they agree to incorporate it. In this way, EEA countries adopt the same rules relating to licensing of medicines and clinical trials as EU member states. National agencies from EEA countries are entitled to standing membership on EMA committees and may act as rapporteur or co-rapporteur in EMA procedures.

	A drug approved by the EMA through a centralized procedure is eligible for marketing in EEA countries in parallel with the EU. However, EEA committee members do not have equal voting rights as those committee members from EU member states and cannot act as committee chair or vice-chair.

 EEA countries can be included in mutual recognition and decentralized procedures in the same way as other EU member states.

	Although the Norway option is appealing to the UK pharma industry because it allows pharmaceutical legislation relative to the UK to be largely maintained, one of the central tenets of the EEA - free movement of people - runs contrary to a key factor in the decision taken by so many of the electorate when they voted to leave the EU; therefore, the UK government may find it a tough sell. The Medicines and Healthcare products Regulatory Agency (MHRA) may also find holding a position of less influence in the EMA to be challenging, having been previously accustomed to a leading role.

	Should imposing some restriction on UK borders be unavoidable, the UK may find itself entirely outside of the EU and any associated constructs. This may be the worst case for the pharmaceutical industry with implications that the regulation of medicines and clinical trials in the UK would be entirely separate from the EU/EEA and that the UK industry would no longer enjoy open access to a large and mobile EU workforce. 

	It would follow that a national application to MHRA would be required to place a new drug on the UK market. Similarly, although the new EU clinical trials regulation will finally offer a centralized submission route for sponsors planning studies in multiple EU member states, sponsors would need to submit a stand-alone clinical trial application to MHRA post-Brexit. 

	Furthermore, any sponsor using a UK-based entity as a EU legal representative would need an alternative arrangement. Whether MHRA would continue to recognize GMP certificates issued by other EU national competent authorities or European Directorate for the Quality of Medicines and HealthCare (EDQM) Certificates of Suitability is unknown. If not, the increase in inspection and drug master file review activities combined with the increase in the licensing workload would mean serious resource implications for the MHRA. 

	Depending on how UK-only regulation evolves, for any company aiming to place a new drug on the market, the requirement to submit to the UK separately from the rest of the EU/EEA risks de-prioritizing the UK from a commercialization strategy. Compromised access to new medicines may therefore be an unwelcome side effect for UK citizens. The UK government may need to explore incentives to preserve UK’s current status as one of the first European countries where new medicines are launched.

	Since the referendum, the MHRA has released two statements to reassure the industry and the public that, for the moment, the agency is as active as ever in European procedures.

 However, a UK exit also has implications for the EMA. It has been widely postulated that continuing to locate the EMA in a country no longer part of the EU is untenable; it is likely the agency will be uprooted from Canary Wharf to the European mainland. Interest in hosting a new agency location from Italy, Sweden and Denmark has been reported so far. In an attempt to dampen speculation, the EMA released a statement in early July to confirm that nothing had been decided and that as far as the agency was concerned it was “operations as usual.”

	Should Brexit result in the UK existing outside of the EU and EEA, another impact on the EMA is the withdrawal of MHRA support from the agency’s assessment resource pool, drawn as it is from EU national competent authorities. The MHRA participates significantly in EMA activities, whether it is acting as rapporteur for centralized marketing authorization applications, carrying out pre-approval GMP and GCP inspection activities, leading scientific advice or protocol assistance procedures, or leading pharmacovigilance referrals. Aside from centralized procedures, the MHRA also provides significant support to the main alternative licensing route, the decentralized procedure (DCP), acting as reference member state in almost half of all procedures in which the UK is included - meaning a potential increase in workload at other national agencies in a scenario where the UK no longer participates in DCPs.

	One further possible outcome might be that of a hybrid approach whereby the UK may leave the EU but negotiate to become a member of the EEA for a finite time period before eventually establishing itself outside of both. This would minimize day-to-day disruption to the UK industry for the short term following an EU exit and provide some time before the EEA exit for thorough negotiations with the EU and third countries (countries outside of the EU and EEA, e.g., US). 

	Although the full implications of Brexit are still unknown, a number of practical steps may be taken in the short term to begin planning for the change. Sponsors may consider establishing an internal Brexit steering committee with multifunctional representation including a recommended minimum of regulatory affairs, pharmacovigilance, manufacturing/supply chain, legal and quality assurance. The role of the committee could include:

		Carrying out a systematic review of the existing business to identify what functions currently rely on UK-based service provision in order to comply with EU requirements, e.g., UK-based EU qualified person for pharmacovigilance.

		Evaluating the anticipated business pipeline over the medium term and assessing the impact of possible Brexit scenarios on clinical development plans, regulatory strategy and commercialization strategies; considering contingency options where necessary. Examples might include planned reference member state selection for upcoming new licensing applications. 

		Monitoring for any new information as Brexit negotiations progress, and communicating regular updates throughout the business.

	With time since the referendum still being measured in weeks, all exit options explored here and more besides are in play. Negotiations in Brussels will be crucial to the post-Brexit picture; however, the UK has been told that negotiations can only begin in earnest once the legislative mechanism for a member state exiting the EU is triggered, i.e., invoking Article 50 of the Lisbon Treaty. Thereafter follows a period of negotiation expected to be concluded within two years. 

	Prime Minister May insists Article 50 will not be invoked until 2017 and so at present, a UK exit will not occur until at least 2019. In the meantime, political uncertainty will present additional challenges to negotiations, with anti-EU feeling in other member states threatening similar exit movements, particularly in France and the Netherlands. Additionally, in Scotland, a 62 percent majority voted to remain in the EU in June’s referendum. Given that the UK only narrowly avoided a breakup following the 2014 Scottish independence referendum, a second Scottish independence referendum appears likely.

	Clearly, as far as European regulatory agencies are concerned, for the moment it is business as usual. This also appears true for the UK pharma industry with both AstraZeneca and GlaxoSmithKline committing to significant investment in their UK operations as recently as the end of July. A joint government-industry steering group was established in early July by then Life Sciences Minister George Freeman, to be co-chaired by AZ and GSK CEOs, to identify key priorities for the UK life sciences sector in the eventual exit negotiations with the EU.

	The pharmaceutical and life sciences sector will be one of many working to influence discussions in Brussels and beyond to secure the best deal for its continued success and to maintain the UK’s reputation as a center of excellence in the field. Many eyes will be watching closely.

	Emma Beausang, PhD, MRPharmS Associate Director, Regulatory Affiars, Chiltern

		UK Life Sciences Manifesto 25-20. Jointly published by UK Bioindustry Association, BioNow, BioPartner and OneNucleus. 

http://www.google.co.uk/urlsa=t&rct=j&q=&esrc=s&source=web&cd=1&		cad=rja&uact=8&ved=0ahUKEwiAvau97ZXOAhVBPI8KHYWGDhgQFgg		eMAA&url=http%3A%2F%2Fonenucleus.com%2Fdownload.ashx%3		Fid%3D1504&usg=AFQjCNHenM61IYHaRZ4X_fZEawYQjpWKEw&		sig2=93ax5fsTm6yqJwp2MVt6qg

		UK Research and the European Union: The Role of the EU in funding UK Research. The Royal Society London UK. December 2015. 

https://royalsociety.org/~/media/policy/projects/eu-uk-funding/uk-membership-of-eu.pdf

		Office of National Statistics 2016. Employment levels by country of birth: People aged 16 and over (not seasonally adjusted). 

http://www.ons.gov.uk/employmentandlabourmarket/peopleinwork/		employmentandemployeetypes/datasets/employmentbycountryofbirth		andnationalityemp06

		CHMP Rules of Procedure EMEA/45110/2007. 

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009		/10/WC500004628.pdf

		Medicines and Healthcare products Regulatory Agency statement on the outcome of the EU referendum. 

https://www.gov.uk/government/news/medicines-and-healthcare-		products-regulatory-agency-statement-on-the-outcome-of-the-eu-referendum

		EMA Press Statement Statement on the outcome of the UK referendum (06/07/16). 

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/		news_detail_002566.jsp&mid=WC0b01ac058004d5c1

		Medicines and Healthcare products Regulatory Agency Annual Report and Accounts 2014/15. 

https://www.gov.uk/government/uploads/system/uploads/		attachment_data/file/448091/Annual-Report-2014-15.pdf

		Medicines and Healthcare products Regulatory Agency Annual Report and Accounts 2015/16. 

https://www.gov.uk/government/uploads/system/uploads		/attachment_data/file/539679/MHRA_annual_report_and_accounts_		2015_to_2016.pdf

		Life sciences: a new relationship with the European Union. Statement from Life Science Minister George Freeman on a new relationship with the European Union and the UK's commitment to the life science sector. 

https://www.gov.uk/government/speeches/life-sciences-a-new-relationship-with-the-european-union

Following the UK’s decision to leave the European Union, the result has been uncertainty and speculation as pharma attempts to understand its implications. How this change will effect the pharma and life sciences industry as well as the European community remains to be seen.

What Could Brexit Mean in Practice for Pharma?

	The industry trend to focus new development on indications where there are few or no existing therapies continues. Targeted indications are often rare, translating into a significant proportion of new approved products having “orphan” status. (From January to April this year, roughly one-third of the new medicines approved in Europe were for orphan products.

) The logistics associated with studying new drugs in very small populations is challenging, but perhaps even more challenging is achieving the right balance between allowing timely access to new therapies and ensuring safety. This much debated balance-allowing patients timely access to new therapies while requiring sufficient data to allow a thorough risk benefit assessment-means that optimizing the regulatory approval pathway for these types of products remains high on the priority list for industry regulators.

	Following a period of planning and consultation, the European Medicines Agency launched in March the latest regulatory initiative in this vein: the PRIority MEdicines (PRIME) scheme.

Existing Regulatory Tools in Europe to Speed Patient Access

	Existing pharmaceutical legislation in Europe provides developers regulatory tools to speed availability of new products. These tools include the scientific advice/protocol assistance procedure, a compassionate use opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), as well as newer development support initiatives such as the adaptive pathways scheme and the EMA’s innovation task force.

	Aside from these, two further regulatory tools are open to applicants. A conditional marketing authorization allows a product to be approved on the basis of a reduced clinical data package with specific postmarketing obligations to provide additional confirmatory data within an agreed period, to be reviewed annually. Conditional marketing authorizations (MA) are granted for one year only, but can be renewed. Another option for earlier market approval is for a product to be granted an expedited review at EMA under the accelerated assessment procedure. This reduces the review period from a maximum of 210 days to 150 days. Specific criteria are applied when considering if a product may be eligible for either a conditional MA or accelerated assessment.

	Given that eligibility is restricted, uptake of these is relatively low compared with the numbers of products approved via the EMA’s centralized procedure under standard mechanisms. In 2015 specifically, just three of the 93 new medicines approved (39 new active substances) had a conditional marketing authorization and just five were approved under the accelerated assessment procedure.

Adapted from table included in “Development support and regulatory tools for early access to medicines” (EMA, 1 March 2016); 

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/03/WC500202631.pdf

	With the launch of the new PRIME scheme on March 7, the EMA aims to build on the existing regulatory framework in Europe to support product development in cases of unmet medical need. By doing so, the EMA strives to encourage development in products likely to make a real difference to patients. Eligibility criteria for PRIME mirror those for accelerated assessment-namely that products are “of a major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation (unmet medical need)” and fall within the scope of the centralized procedure.

	PRIME’s principal advantage is that it allows sponsors to have an early and proactive regulatory dialogue with the EMA, which should help them optimize clinical trial design and generate robust data to support an eventual marketing authorization application (which would in turn be expected to be eligible for accelerated assessment). 

	Under the scheme, additional benefits include the early appointment of a rapporteur from either the CHMP or Committee for Advanced Therapies (CAT) to allow knowledge build at the EMA committee level ahead of a future MAA, as well as identification of a dedicated contact person with EMA. In addition, a kickoff meeting with the rapporteur and a multidisciplinary group of experts is envisaged to provide guidance on the overall development plan and regulatory strategy.

An eligibility request, accompanied by a justification, should be submitted in order to apply for the benefits of the scheme. There is no fee associated with the request. The timing of the request is expected to be early in development once preliminary clinical evidence (proof of concept) is available for the product. In recognition that academic research groups and small or medium-sized enterprises (SMEs) may be less knowledgeable about the regulatory framework and may benefit from earlier interaction, access may be granted in these cases on the basis of compelling nonclinical data and tolerability data in humans. 

PRIME vs. FDA Breakthrough Therapy Designation

	Parallels have been drawn between the new PRIME scheme and the U.S. FDA’s breakthrough therapy designation program, available since July 2012. The broad scope and intent of both initiatives are indeed similar, aimed at optimizing development and accelerating approval for new products that potentially may fulfill an unmet need. To that end, both also encourage early and frequent dialogue between regulators and sponsors.

	While PRIME is a development support program that leverages existing early access regulatory tools that are specifically permitted by EU legislation (e.g., accelerated assessment), the legal basis for the breakthrough designation program is itself defined within the Food and Drug Administration Safety and Innovation Act (FDASIA). Breakthrough designation is limited to products aimed at treating serious conditions.4 Although not explicitly stated within the scope for the new EMA scheme, by virtue of it being limited to products falling within the scope of the centralized procedure, as well as the eligibility criteria that will be applied, the same may be said of PRIME.

	Additionally, both require preliminary clinical evidence of effectiveness (PRIME allowing some leeway for academia and SMEs to participate even earlier in development, more closely reflecting the criteria for the FDA’s fast track designation program). Guidance documents providing more detail regarding the preparation of PRIME eligibility requests, including what may be required by way of justification, are available on the EMA website.

	Breakthrough designation does differ in one respect, in allowing for “rolling review” of the licensing application dossier, a benefit that is not yet allowed within existing pharmaceutical legislation in Europe. Notwithstanding, an initial assessment suggests that the two schemes appear more alike than they are different; however, this will become clearer as experience with the new PRIME scheme grows.

	The scale of uptake for the PRIME scheme remains to be seen given that it is still in its infancy. The U.S. FDA’s breakthrough designation program has been encouraging with a total of 129 drugs or biologics receiving the designation since the program launched in 2012, and 43 of these subsequently obtaining market approval (figures accurate to March 31/April 1, 2016).6 Monthly reports from the CHMP, released after each meeting, will include information on any recommendations given regarding PRIME eligibility requests (although only products confirmed as being eligible will have the active substance or INN shared publicly) and therefore its use will gradually become apparent.

	PRIME is a welcome addition to the development support tools offered by the EMA in Europe and looks well placed to contribute to the EMA’s stated objective of optimizing clinical development to ensure safe and timely access to novel medicines for patients.

	Emma Beausang PhD MRPharmS is the Associate Director of Regulatory Affairs at Chiltern

http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000378.jsp&mid=WC0b01ac0580028d2a

		European Medicines Agency Annual Report 2015 

http://www.ema.europa.eu/docs/en_GB/document_library/Annual_report/2016/05/WC500206482.pdf

		European Medicines Agency Guidance for applicants seeking access to PRIME scheme; 7 March 2016; EMA/191104/2015	

		US FDA Guidance for Industry Expedited Programs for Serious Conditions â Drugs and Biologics, May 2014

		Enhanced early dialogue to facilitate accelerated assessment of PRIority MEdicines (PRIME); 25 February 2016; EMA/CHMP/57760/2015	

		US FDA Frequently Asked Question: Breakthrough Therapies 

http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm

In response to the debate over allowing patients timely access to new therapies and ensuring safety, the EMA launched the PRIority MEdicines (PRIME) scheme in March. The aim of this initiative is to build upon existing regulations in Europe to support product development in cases of unmet medical need.

Emma Beausang, PhD

Articles

Where’s the Exit? An Update on Brexit

What Could Brexit Mean in Practice for Pharma?

EMA’s New Tool: PRIME