prescription medicines Archives - European Industrial Pharmacists Group (EIPG)

A concept paper on the revision of Annex 11


This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP) guideline. Annex 11 is common to the member states of the European Union (EU)/European Economic Area (EEA) as well as to Read more

What happens after IP loss of protection


by Giuliana Miglierini What does it happen under a competitiveness perspective once intellectual property (IP) protection for medicinal products expired? And what is the impact of the new entries on generics and biosimilars already in the market? The role of competitor Read more

The FDA warns about the manufacture medicinal and non-pharmaceutical products on the same equipment


by Giuliana Miglierini A Warning Letter, sent in September 2022 by the US FDA to a German company after an inspection, addresses the possibility to use the same equipment for the manufacturing of pharmaceutical and non-pharmaceutical products. The FDA reject Read more

EFPIA’s Annual Report on the Pharmaceutical industry 2022

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by Giuliana Miglierini

In the 21 years from 2000 to 2021 – in which time we’ve come through the Global Financial Crisis and a pandemic – EFPIA companies have more than doubled production, increased exports by a factor of six, and recorded a trade balance that puts it far ahead of other high-tech sectors in Europe”, writes EFPIA’s Director General Nathalie Moll commenting the Annual Report2022.

Despite this marked growth, many challenges are still to be faced to allow the European pharmaceutical industry to maintain and even strengthen its role as primary hub of innovation, thus contributing to the overall success of the EU’s economy. It can be expected, for example, that the energy crisis will be highly impacting pharmaceutical productions, also in the form of increased difficulties to guarantee a constant supply of raw materials. This would represent just the last drop adding to existing regulatory barriers slowing down R&D and to the impact of fiscal austerity policies that may discourage investors.

At the same time, we have seen the growth of Brazilian, Chinese and Indian markets outstrip growth in the top 5 European markets. Our global competitors have prioritised life sciences and we must respond with similar ambition”, adds Nathalie Moll.

The 2021 of the pharmaceutical industry

According to EFPIA’s Annual Report 2022, the value of production for the research-based European pharmaceutical industry has grown from 127.5 billion euro in year 2000 to 300 billion in2021. Even more relevant is the growth of export, increased from €90.9 bln to €565 bln over the same period. In 2021 imports counted for €390 bln, with a positive trade balance of €175 bln.

The research-based pharma industry employed last year 840,000 units (125,000 of which in R&D) and invested €41.5 bln in research and development activities.

The total European pharmaceutical market value at ex-factory prices increased from €89.4 bln in 2000 to €255 bln in 2021. The pharmaceutical expenditure supported by statutory health insurance systems (and referred to ambulatory care only) grown from €76.9 bln to €157.5 bln over the same time.

Despite these positive figures, EFPIA warns about the danger of migration of many R&D activities from Europe towards fast-growing markets such as Brazil, India and China, thanks to the more favourable conditions. The pharmaceutical market in these countries grown, respectively,11.7%, 6.7% and 11.8% in the period 2016-2021, compared to 5.8% of top EU countries (France, Germany, Italy, Spain and United Kingdom) and 5.6% of the US.

North America still represents the wider market area for pharmaceuticals (49.1%, vs 23.4% for Europe), and accounts for the higher proportion of new launches (64.4%, vs 16.8% of top five EU countries). In 2020 China marked the higher pharmaceutical R&D expenditure (78,5 billion Yuan, from 1.9 bln Yuan in 2000), overcoming for the first time the US ($72.4 bln), while Europe is positioned far behind (€39,7 bln). Not less interesting is the 3.2% market share assigned to emerging, high-growth pharmaceutical markets including many African, South American and Asiatic countries (Algeria, Argentina, Bangladesh, Brazil, Colombia, Chile, China, Egypt, India, Indonesia, Kazakhstan, Mexico, Nigeria, Pakistan, Philippines, Poland, Russia, Saudi Arabia, South Africa, Turkey and Vietnam).

Parallel trade is a characteristic of the European pharmaceutical market, due to the persistent fragmentation of many policies in different countries. Denmark saw in 2020 the higher share of parallel imports in pharmacy market sales (26.9%), well above other countries (e.g. 10.9% Sweden,9.1% UK, 8.3% Germany).

 Issues slowing down R&D

According to EFPIA, the length of time needed to bring a new medicine to the market (up to 12-13 years) is still a major issue impacting the attractiveness of European R&D. An average of one-two new synthetic substances out of every 10 thousand exiting the labs passes all the scrutiny steps needed to reach approval. The total costs of R&D was estimated in 2014 to reach €1.97 billion, indicates the report.

Germany, Switzerland and the UK are the European countries more active in research and development (€7.8 bln, €7.4 bln and € 5.6 bln expenditure in 2020, respectively). Clinical research accounts for the higher percentage of investment (44.1%, mainly in phase III studies), far above pre-human and pre-clinical research (14.9%) and phase IV studies aimed to post-marketing surveillance (11.5%). Approval studies account for 4.3% of the total R&D expenditure.

The US generated 159 new chemical entities (both chemical and biological) in years 2017-2021, almost doubling Europe (72) and a group of other countries (71), excluding Japan (41). Even more worrying, in 2021 China lagged just behind Europe as originator of new active substances launched for the first time on the world market (18 vs 19, respectively), while the US confirmed its leading position (35). According to EFPIA, this trend is associated with a marked lower annual growth rate of pharmaceutical R&D expenditure in Europe (4.0% for years 2017-2021), compared to that in the US (8.5%) and China (12.9%). Despite this, health industries still position at the first place of the ranking of industrial sectors by overall R&D intensity (12.4%, vs 8.7% of ITC services and 7.4% of ITC products).

The pharmaceutical production

Switzerland, Germany and Italy are the leading European hubs for pharmaceutical production (€53.2 bln, €32.3 bln and €34.3 bln of value, respectively). This corresponds in Germany to a significant higher number of people employed in the sector (115,519, vs 66,400 in Italy and 47,000 in Switzerland). EFPIA also mentions that the research-based pharmaceutical industry generates about three times more indirect employment along its value chain (both upstream and downstream) than it does directly, thus significantly contributing to the overall European job market. This is even more true for highly skilled jobs, thus preventing the phenomenon of brain-draining towards more attractive countries for scientific talents.

The US remains the favoured trading partner for the EU pharmaceutical industry, accounting for 32.2% EU exports and 30.2% imports. Switzerland is at the first place for EU imports (36.4%, and 11.8% EU exports); more distanced are the UK, China and Japan.

Fragmentation still impacts the European market

Fragmentation of policies on price and reimbursement and different VAT rates for medicinal product sis a very typical phenomenon still limiting the potentiality of the European pharmaceutical market.

According to EFPIA, in 2020 the retail price of a medicine corresponded on average to 66.8% rewarding for the manufacturer, 17.4% for the pharmacist, 10.6% for the State and 5.2% for the wholesaler. The top 5 countries for market value at ex-factory prices were Germany (€42.9 bln), Italy (€23.4 bln), France (€29, 5 bln), the UK (€24.6 bln) and Spain (€17.6 bln); Russia also represented a relevant market (€18,4 bln). Italy sees the higher market share for generics (67.6%), well above Poland (58%) and Austria (49%). EFPIA also monitored the VAT rates applied to prescription and OTC medicines in different European countries, compared to the standard VAT rates. Malta (0%), Sweden (0%), France (2.1%), Switzerland (2.5%), Luxembourg (3%), Spain (4%), Lithuania, Croatia, Cyprus, Hungary (5%) marked the lower VAT rates on prescription medicines. In some case, these same rates applies also to OTC products (Croatia, Cyprus, Hungary, Luxembourg, Malta, Spain, Switzerland), while in other countries the rates for this category of medicines is higher (France 10%, Lithuania 21%, Sweden 25%).


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.