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Background – pharmaceutical and health technology

Pharma industry is an example in the UK where items and services are traded within healthcare. The components of pills/tablets/capsules/creams/fluids etc may be developed by multiple manufacturers in and outside the UK with both the active pharmaceutical ingredient as well as excipients. Regulation for efficacy and safety after a marketing authorisation provided by MHRA also continues with pharmacovigilance where authorisations can be withdrawn, companies shut down based on either or both unanticipated side effects or improper manufacturing, laboratory, clinical practice.

UK pharmaceutical market 2008 – 2015 from ABPI. In addition – multiple organisations known as contract research organisations also support the manufacturing and regulatory process to obtain a marketing authorisation – map

Statistics for marketing authorisations granted since 2014

Generics are medicines developed after the exclusive authorisation period has ended, allowing for cheaper pricing. UK generics market video overview

Comparison of generic medicines in US , Europe and pricing

Health technologies are more complicated as a technology which is not claiming medical and clinical benefits can be all kinds of items – medical devices(generally a physical item/hardware), apps (software).

WHO report , recommended WHO guidance

Medicines pricing:

Within the UK, NICE make recommendations for the NHS to fund medicines based on clinical and cost effectiveness.

Medicines reimbursement policies in Europe

Within the EU

In the EU, national authorities are free to set the prices of medicinal products and to designate the treatments they wish to reimburse under their social security systems. At the same time, pricing and reimbursement systems are closely linked to the realisation of European policy objectives such as the internal market, pharmaceutical competitiveness, sustainable research and development, and the protection of human health. The variety of healthcare and social security systems in the EU has an impact on the pharmaceutical industry, wholesalers, pharmacists, doctors, health insurers, and patients.1

The NHS also buys

Before the NHS was broken in 2012, there were national procurement and supply processes. Some examples of the largest spend

Trade agreements

Pharmaceutical greements for regulatory standards some of which include trade and tariffs are continually assessed for harmonisation, both within Europe and the wider international community. The Eurasian Economic Union launched a common medicines market in 2017 and also increasingly standardising regulation of medical devices. There is also development of common EAEU and EU ground but I don’t think mutual recognition agreements (e.g. for medicines) are in progress yet.

For sake of time, will not go into other traded items as per the above, but brief look at the TTIP agreement and how this and Brexit relate to the NHS.

Joseph Stiglitz discusses healthcare, TTIP and the big pharmaceutical companies’ interests:

TTIP was halted by a European wide campaign including UK trade specialists, lawyers, clinicians and many other campaigners. There was very little transparency and very limited time for parliamentary representatives to read through the materials that were released. That does not mean that future US-EU trade agreements will not try to include healthcare particularly as the FDA (US medical and food regulator) agreements and standards are less stringent than EU and EMA ones.

Brexit and healthcare impacts TheLancet – free registration

Particularly,

Leaving the EU might free the NHS from some of the obligations of EU competition and public procurement law, thereby making it possible to roll back market-oriented reforms to the English NHS, such as those in the 2012 Health and Social Care Act. EU law has often been considered to promote marketisation and competition in health services. However, the magnitude of concerns is not matched by the reality of EU law in this area. EU law provides many exemptions for public services, in particular under the description of services of general interest, and in most cases it is a matter for national governments as to whether they do open their health systems to competition, although if they do they must then abide by relevant EU law.

The UK Government, not the EU, decided in the 2012 Act to impose EU competition law on health care in England. Importantly, the Treaties and a succession of rulings of the EU’s Court of Justice have served to protect health services in several member states from potential consequences of internal market provision. It is very unlikely that these protections would be replicated in any future trade deals with, in particular, the USA. It might be, though, that being formally removed from the application of EU competition and procurement law might reassure perceived concerns in a way that would create scope for more efficient organisation of the NHS.

The UK has played a key role in the EU’s regulation of biomedical research and has benefited substantially from collaborative EU research funding in biomedical fields. For example, many EU-funded rare diseases networks are led by UK-based clinicians. EU law underpins information exchange in cross-border clinical trials, as well as setting regulatory standards and broad requirements for ethical oversight, although marked discretion remains at national levels. The new Clinical Trials Regulation will provide centralised infrastructure in a single EU portal, facilitating access to the EU market for new drugs. All these arrangements continue under the Withdrawal Agreement.
Under the backstop, products in EU-based clinical trials could still be sourced from Northern Ireland, but the service of conducting a clinical trial is not covered by the Protocol, and so access by UK entities to cross-border clinical trials within the EU would end.The Political Declaration envisages a relationship centred around an Free Trade Agreement; how far the EU’s rules on trade and competition would continue to apply to the UK would thus depend on the depth of that agreement. Continued participation in EU programmes such as research and technological development is anticipated, but on worse terms for the UK, with negative consequences for the UK’s global leadership and influence across a range of research areas.Ironically, collaboration on public health is specifically proposed at a global level, though not at a European one.
Under a No-Deal Brexit, all collaborations (eg, research, reference networks, shared health-care services, and cross-border treatment of patients) would immediately lose the legal basis on which they are conducted, making data sharing across borders impossible unless the EU formally recognises the UK’s data protection laws as compliant with EU law—which they would be if rolled over into retained EU law under the EU (Withdrawal) Act 2018, unless amended—and access to funding would end, presumably with immediate effect. Regulatory uncertainty under No Deal has already halted one clinical trial in Scotland in December, 2018…
…In summary, our analysis suggests that leaving the EU under any of the four scenarios would be worse for the NHS than remaining. However, by far the worst option would be a No-Deal Brexit. The Withdrawal Agreement is likely to have many adverse consequences but will also allow much to remain as it is until December, 2020. The impact of the backstop is likely to be uneven, effectively enabling continuity in some areas (in particular for medical products, vaccines, and technology), but producing a negative impact in most other areas.2

The impact of Brexit on patients and the NHS

The impact of Brexit on regulating pharmaceutical and clinical trials


1. https://ec.europa.eu/growth/sectors/healthcare/competitiveness/products-pricing-reimbursement_en
2. Fahy et al (2019) How will Brexit affect health services in the UK? An updated evaluation Health Policy| 393: 10174, P949-958, The Lancet [Online] available at https://doi.org/10.1016/S0140-6736(19)30425-8