Bio-Science Law Review - Volume 18 - Issue 4
AFFORDABLE MEDICINES AND INNOVATION: CONSEQUENCES AND LESSONS FROM COUNTRIES WITH DIFFERENT PATANTABILITY STANDARDS
PRATHEEBA VIMALNATH, OLGA GURGULA, NICK SCOTT-RAM, CHAS BOUNTRA AND WEN HWA LEE
Oxford Martin Programme on Affordable Medicines, University of Oxford
The problem of affordability and accessibility of life saving medicines and the decline in breakthrough drug innovation has been a global public healthcare crisis for decades. Despite several policy and regulatory reforms, the patent eligibility of both breakthrough and incremental pharmaceutical inventions has led to strategic patenting practices that enable pharmaceutical companies to prolong their market monopoly causing extended period of inflated drug prices. This article argues that the existing patent systems do not support the creation of affordable and much-needed pharmaceutical innovation, but encourage incremental rather than breakthrough innovation, resulting in what the authors call ‘the Dorian Gray Paradox’. They urge all the stakeholders to work together in experimenting with new arrangements and models with higher degree of openness aimed at maximising the balance between private and public interests in medicines for the future.
UK ORPHAN DRUG PROTECTION, POST-BREXIT: STATUS AND REFORM
PAUL ENGLAND Taylor Wessing, London
The most powerful exclusivity right available to medicinal products after patent protection is orphan drug status. Unlike patents, this form of protection is awarded according to the small size of the applicable patient population and clinical benefit. However, although the clinical benefit requirements of the EU orphan drug legislation are business critical for companies wishing to benefit from this form of protection, they. are poorly conceived and confusing, with different but duplicative definitions and associated guidance. This article explains how the EU legislation has been inherited in the United Kingdom, post-Brexit, the problem in the drafting, and how this can be resolved in the applicable domestic regulations.
A DEFENCE OF COVID19 VACCINE PATENTS
SCARLETT SWAIN Durham Law School, University of Durham
The unprecedented swift development of effective Covid vaccines has given rise to two questions: whether it is right that pharmaceutical companies should be allowed to profit from a global pandemic, and whether these patents are actually stimulating innovation. This article aims to counter these criticisms, and demonstrate the benefits of the patent system, inter alia in boosting innovation. Focusing on the Pfizer and BioNTech, and Oxford and AstraZeneca vaccines, it presents the economic, physical, and mental benefits for societies that the expeditious creation of these vaccines has produced, and will continue to produce, and shows the importance of understanding the source of their funding.
POLPHARMA: EU GENERAL COURT DECISION SIGNALS CHANGE TO REGULATOR'S APPROACH TO ASSESMENT OF GLOBAL MARKETING AUTHORISATIONS
GARETH MORGAN, NATALIE COAN AND HANNAH RIGBY
Pinsent Masons, London
In Case T–611/18, Polpharma, the EU General Court annulled the decision of the European Medicines Association not to validate Polpharma’s generic application for the MS treatment dimethyl fumarate referencing the authorised product Tecfidera. The authors call for an administrative revamp of the regulatory exclusivity system in light of the court’s direct engagement with its flaws.
PSYCHEDELIC MEDICINES: REGULATORY HURDLES TO DEVELOPMENT IN THE UK
SIAN BANKS Pinsent Masons, London
Researchers have only recently begun to investigate the potential benefits of psychedelic substances as alternative therapies for neurological diseases and some mental health conditions. This comment considers the regulatory hurdles in the UK that will need to be cleared before such new drugs can be brought to market, in particular narcotics legislation,compliance with rules on access and benefit-sharing, and compliance with the Nagoya Protocol in the UK.