Code of Practices for the Pharmaceutical Industry Archives - European Industrial Pharmacists Group (EIPG)

Environmental sustainability: the EIPG perspective


Piero Iamartino Although the impact of medicines on the environment has been highlighted since the 70s of the last century with the emergence of the first reports of pollution in surface waters, it is only since the beginning of the Read more

How AI is Changing the Pharma Industry and the Industrial Pharmacist's Role


Svala Anni, Favard Théo, O´Grady David The pharmaceutical sector is experiencing a major transformation, propelled by groundbreaking drug discoveries and advanced technology. As development costs in the pharmaceutical industry exceed $100 billion in the U.S. in 2022, there is a Read more

Generative AI in drug development


by Giuliana Miglierini Generative AI is perhaps the more advanced form of artificial intelligence available today, as it is able to create new contents (texts, images, audio, video, objects, etc) based on data used to train it. Applications of generative Read more

A golden era for UK’s life sciences and a new Code of practice for its pharmaceutical industry

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by Giuliana Miglierini

Less than a year has gone since the Brexit, and the UK innovation landscape is experiencing a new, vivid era of expansion under the stimulus of a strong demand from global investors. According to recent data of the BioIndustry Association (BIA) and Clarivate, the second quarter of 2021 (March – May) saw £1.56 billion investments, a record value for a quarter since the trade association began recording this data.

A record year for investments
The first semester has registered a total of £2.39 bln investments, almost the same amount raised in the entire 2020 (£2.81 bln). “The scale of these financings suggests 2021 will be another record year of investment into UK biotech companies. We continue to see deals being driven predominantly by investors from outside of the UK. Our hope is that the Government’s impending Life Science Sector Vision will be a platform for the UK’s financial institutions to add further fuel to take this sector into a golden age.”, said Dr Martin Turner, Head of Policy and Public Affairs at the BIA.
More in detail, UK biotech and life science companies raised £1,07 billion in venture capital; thirteen deals overcame £20 million, and four of them even £100 mln. The 60% of the total biotech venture capital invested in Europe is represented by UK companies; furthermore, £431 million was raised through three NASDAQ IPOs and £58 mln in follow-on public financings. “These figures show that our life sciences sector is booming, demonstrating the confidence that global investors have in the UK. The extraordinary innovation underway in the sector will not only increase our resilience against future healthcare challenges, but will boost the economy, create highly skilled jobs across the country, and enhance our status as a science superpower”, said Life Sciences Minister Nadhim Zahawi.
Biotech shares on the London Stock Exchange also continued to out-perform the wider market in the first half of 2021, according to the report prepared by Radnor Capital Partners on behalf of the BIA.

A new Vision of the life sciences sector
The UK government published it’s new Life Science Vision on 7 July, a 10-year strategy for the sector which builds on the success of the previous 2017 Life Sciences Industrial Strategy.
The same approach used to fight the Covid-19 pandemic will be used as a blueprint to tackle some persisting health issues such as dementia and cancer, for a total of seven critical missions. The others include early diagnosis and treatments, comprehensive of immune therapies and cancer vaccines, vaccine discovery, treatment and prevention of cardiovascular diseases and its major risk factors (i.e. obesity), reducing mortality and morbidity from respiratory disease, addressing the underlying biology of ageing, increasing the understanding of mental health conditions and redefining tools to fight them.
The new strategy also includes planned investments for a total of £1 billion, to be dispensed under the Life Sciences Investment Programme (LSIP). The programme is expected to boost further private sector investment, and the creation of a world leading UK life sciences venture capital ecosystem. The investments will be delivered through British Patient Capital (BPC), part of the government-owned British Business Bank, which will allocate the £200 million to specialist funds. Some other £800 mln will result from the collaboration between BPC and Abu Dhabi’s Mubadala Investment Company, one of the world’s leading sovereign investors. The LSIP will have access to a scientific advisory panel composed of leading industry figures, chaired by Professor Sir John Bell and in charged to share insight on key scientific trends.
“We are indebted to the ingenuity of UK life sciences and its pioneers, with the discovery of the Oxford-AstraZeneca vaccine and the seamless collaboration between our scientists, industry, regulators and NHS saving millions of lives during the pandemic. We must make sure this is the norm and use this new way of working to search for life-changing breakthroughs against diseases such as cancer, dementia and obesity, as we have done with Covid”, said Prime Minister Boris Johnson.
“Crucially, we’re going to build a pro-enterprise environment where our life sciences firms can access the finance to grow, are incentivised to onshore manufacturing, and can commercialise breakthrough products right here in the UK – rather than elsewhere – as we cement the UK’s position as a science superpower”, added Business Secretary Kwasi Kwarteng.
Central to the new Vision is the emulation of the approach used by the UK Vaccines Taskforce to fully exploit the private sector expertise while removing unnecessary bureaucracy. New regulatory freedoms and opportunities are expected for the UK life science business sector as a result of the country’s new position outside the EU. The UK’s regulatory agency MHRA is expected to act as an independent, sovereign regulator with great agility and with a focus on getting vaccines, drugs, and technologies to patients as safely and quickly as possible.
“The BIA’s focus will be to increase the expert pool of UK based capital needed for innovative UK life science firms to grow to scale. This will enable UK investors and pension savers, to secure the economic benefit from this burgeoning golden age for UK life sciences while at the same time enabling NHS patients to secure the health benefit of global biotech innovation”, said BIA’s Chief Executive and former member of the Vaccine Taskforce Steve Bates.

A new Code of Practice for the pharmaceutical industry
The renewal of the UK’s landscape in life sciences also pass through the new Code of Practice for the Pharmaceutical Industry, which has become operative since 1st July 2021 without transition period, with the exception of companies wishing to continue with ongoing Medical and Educational Goods and Services where the transition period will close on 31 December 2021.
The Code published by the Association of British Pharmaceutical Industry (ABPI) is operated under the supervision of the Prescription Medicines Code of Practice Authority (PMCPA), established by ABPI in 1993 as an independent organism. The previous version of the code was released in 2019.
The Code provides indication on the acceptable practices for the promotion of prescription medicines to both health professionals and other relevant decision makers. Requirements for interactions with health professionals and standards for the provision of information about prescription medicines to the public and patients (including patient organisations) are also included.
There are four principles inspiring the document, first among which the benefit and safety of patients. Integrity and commitment towards responsible, professional, ethics and transparent relationships, transparency and respect will guide the future activities of the UK pharmaceutical industry in the promotion of medicines.
Even if the Code refers only to activities carried out by the industry, its indications should also inspire individuals and organisations in their interactions with the pharmaceutical environment.
Training of personnel and robust operating procedures to review all materials and validate their compliance to the rules highlighted by the Code and other legal requirements are other principles inspiring the document. The Code incorporates some other references important in the field of the promotion of pharmaceutical products, among which those contained in the Codes of Practice of the International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA), the European Federation of Pharmaceutical Industries and Associations’ (EFPIA), the WHO’s Ethical Criteria for Medicinal Drug Promotion, the EU’s Directive 2001/83/EC and 2004/27/EC on human medicinal products, and the Human Medicines Regulations 2012 No. 1916.