Table 2.

Three mechanisms of EU regulatory influence over access to medicines in LMICs and their known impacts.

Mechanisms of EU influence	Area of EU law, regulation, or policy	Nature of impacts in LMICs	Illustrative publications
Explicit agreements between EU-LMICs
EU enlargement	Candidate EU member states harmonize local standards with EU regulatory data protection	(no data)	[25]
	Candidate EU member state recognises on its local market approvals granted through EU procedures	At the time of accession about 1/3 of market approvals in the candidate member state were granted through the EU recognition procedure, and 2/3 through national authorization After accession the majority of new market approvals in the new EU member state were granted through EU procedures	[26]
EU-LMIC trade agreements and economic partnerships	LMIC trade partners adopt longer periods of regulatory data protection and patent extensions	Lost savings on pharmaceuticals Potential for reduced availability and market shares of generic medicines launched on LMIC markets post-EU trade agreement	[29]
	LMIC trade partners remove tariffs on EU pharmaceutical imports	Minor welfare benefits for LMICs due to ‘cheaper’ imported medicines from EU Possible negative effects for LMICs’ trade relations with other medicines exporting countries	[7]
EU internal market action affects LMICs
EU exports and shipments transiting through EU	Waiver for EU patent term extensions allow generic and biosimilar medicines to be produced in the EU for export (patent term extensions are also called supplementary protection certificates)	(no data)	[32]
	Measures to prevent the re-importation into the EU of low-priced medicines for HIV/AIDS, TB, malaria intended for LMICs	List prices of medicines registered under this system are not significantly lower than for products supplied outside of this regulation nor the same products sold in other countries	[35]
	EU customs enforcement measures	Detention of shipments of generic medicines in transit through the EU and destined for LMICs. Shipments are delayed reaching LMICs or are returned to their country of origin.	[30]
EU internal regulation influences actors in LMICs to adhere to EU standards	In order to access the EU market, medicines manufacturers and their affiliates must declare to have followed good clinical practices and ethical standards during clinical development	(no data)	[41]
LMIC regulatory reliance and mirroring of EU internal market regulation	LMIC regulators recognize or abbreviate the EC's market authorization decisions for new chemical entities on local markets	May result in expedited regulatory approval of essential medicines in LMICs. May reduce LMICs’ autonomy over their regulatory decisions, which is problematic when the EU's decisions being mirrored have a weak evidence base.	[43] [45]
‘Soft’ forms of EU influence on LMICs
EU technical assistance, resource mobilization and ‘capacity building’	Through the EU-Medicines4all (Article 58 procedure) the EMA assesses and provides scientific opinions of new medicines solely intended for third countries (usually LMICs)	Six medicines with positive EMA opinions were granted 138 regulatory approvals in 90 countries.	[60]
	EU funding for research and clinical development of pharmaceuticals for neglected infectious diseases (e.g., EDCTP)	Development and market approval of new medical products (e.g., first malaria vaccine, RTS,S)	[66]
	EU coordinates development funding for harmonizing LMICs’ pharmaceutical regulation and establishing pooled procurement	(no data)	[68]
	EU-funded humanitarian aid organizations must respect internationally recognized principles of good practice for medical products for procuring medicines	(no data)	[18]