Standing the Test of Time

Over the course of the past three decades, since Pharmaceutical Technology Europe was launched, much has changed within bio/pharma. Industry has witnessed periods of growth, followed by strategic divestiture in more recent years, a boom in biologics, regulatory harmonization, as well as significant technological advances, to name but a few. Added to these specific industry shifts, overarching societal and economical changes, such as government changes and Brexit, have also left a mark on bio/pharma and are set to continue to impact the industry for some time to come.

In looking back over the 30 years that Pharmaceutical Technology Europe has been reporting on industry developments, several trends have clearly shaped the industry, while some other trends have perhaps done so a little less obviously. For this special anniversary issue feature, the editors take a trip down memory lane to cover some of the major happenings of the bio/pharma industry over the past three decades.

Begin at the beginning, 1989

Well, ‘begin at the beginning’ is a little misleading, as the ‘beginning’ for Pharmaceutical Technology Europe does not represent the beginning of the bio/pharma industry itself, but it does offer a nice starting point in terms of news and developments. 

The first issue of the magazine was published in 1989-a big year in Europe, which saw the fall of the Iron Curtain and Berlin Wall. The year also gave rise to some interesting developments in bio/pharma. One such development was the introduction of the first ever proton pump inhibitor (PPI), omeprazole, by Astra (1)-which 10 years later would merge with Zeneca in one of the biggest European merger deals of its time. PPIs now represent one of the most frequently prescribed drugs in the world (2).

Other introductions in 1989 included the addition of the conjugated Haemophilus influenza vaccine to routine national immunization programmes of certain European countries (3), and the initiation of supplementary rules for the authorization of vaccines and medicines derived from blood (4). Furthermore, measures to improve the quality of medicines throughout Europe were also taken in 1989 with the introduction of the first guidelines on good manufacturing practices (5).

The 1990s: Regulatory harmonization and intense M&A activity

The start of the 1990s brought with it the inauguration of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), creating a platform for international cooperation (5). Since its inception, the ICH has evolved so that farther-reaching global harmonization of regulatory requirements-beyond that of the founding regions of Europe, United States, and Japan-may be attained.

Moving into 1993, Europe began an exciting time as the Single Market was completed, comprising ‘four freedoms’ of movement of goods, services, people, and money; the Maastricht Treaty came into force, formally establishing the European Union (6). In 1995, the European Medicines Agency (EMA) became operational with the mission of promoting and protecting public and animal health throughout Europe (7).

The then London-based regulatory body started work immediately, approving its first drug for human use, Gonal-F (follitropin-alfa) through the centralized procedure in October 1995. This approval marked an important milestone, as stated in the first general report of the European agency (8). In addition to Gonal-F, Taxotere (docetaxel), and Betaferon (interferon beta-1b) also gained marketing authorizations in November 1995 (8).

A year later, 1996, a landmark achievement was attained in the treatment of HIV as lamivudine, ritonavir, and saquinavir were approved through the centralized EU-wide procedure under exceptional circumstances (9). These three HIV protease inhibitors, used in combination with nucleoside reverse transcriptase inhibitors, would set about a dramatic change of course of the HIV epidemic (10). 

But, it wasn’t just regulatory achievements and market approvals making waves during the 1990s. M&As were intensifying with activity within the global pharmaceutical-biotechnology industry being valued as exceeding US $500 billion (€449 billion) in the period between 1988–2000 (11). 

Consolidation, specialization, and Brexit-noughties to now

Roll on to the early-to-mid noughties and the M&A activity continues. ‘Bigger is better’ seemed to be the mantra for many bio/pharma companies, which looked to strategically operate with vast R&D hubs situated in multiple global locations. 

The strategy of creating massive conglomerated operations has been attributed to the decline in R&D productivity that the industry was experiencing (12) and justified through economies of scale. Looming patent cliffs for many of the blockbuster drugs and the advent of personalized therapies has certainly led to a shift in momentum within the industry. Adoption of a leaner, more focused business model was inevitable and started being seen in the industry from the late 2000s (12).

As discussed by Sylvia M. Findlay in the December 2006 issue of Pharmaceutical Technology Europe (13): “The shift of focus towards manufacturing drugs catering to a niche market is critical in tackling the declining revenue in pharma. Personalized medicines are becoming attractive to drug manufacturers and are likely to be big hit among the diseased population. These drugs herald the burgeoning of specialty pharmaceuticals.”

In the regulatory space, EMA started efforts to get more treatments on the market that targeted rare diseases by adopting a new legislation (14). Applications for orphan therapies submitted to EMA peaked between 2011 and 2015 when a total of 1151 applications were received (15). Also, EMA adopted legislations on medicinal products for paediatric patients (2006) and for advanced therapy medicinal products (2007), mirroring the emergence and development in the industry of more specialized areas of medicines (6). 

Of course, it would not be possible to discuss key developments impacting the bio/pharma industry without touching on Brexit. After the United Kingdom made its decision to leave the EU in 2016, work has been ongoing to prepare for every eventuality while also ensuring patient safety does not suffer too much. Brexit has already hindered the European bio/pharma industry, with commotions resulting from the relocation of EMA and the uncertain future already leading to a collapse in confidence in the region as an attractive place to do business (16). 

Trailblazing in health equality

In tackling health equality across the region, the World Health Organization’s Regional Office for Europe regularly reports on the state of health and well-being throughout Europe, which is closely linked to its overarching policy-Health 2020. The most recent report (17) revealed positive developments across the region but also emphasized that effective communication of health information and use of data can help to bridge the research-policy gap.

“The European Region’s member states have in many ways been trailblazers in supporting and defining a vision for a truly forward‑looking principle of information systems for health, thus making data, information, research, and evidence count for all of us-ensuring the availability of ‘evidence for all’,” stated Zsuzanna Jakab, WHO regional director for Europe (17).

References

1. D. Taylor, “The Pharmaceutical Industry and the Future of Drug Development” in Pharmaceuticals in the Environment, R.E. Hester and R.M. Harrison Eds., pp. 1–33 (The Royal Society of Chemistry, London, UK, 2016).
2. H. Luo, et al., BMC Health Serv. Res. 18 537 (2018).
3. R. Whittaker, et al., Emerg. Infect. Dis., 23 (3) 369–404 (2017).
4. European Council, Council Directive 89/342/EEC-Extending the Scope of Directives 65/65/EEC and 75/319/EEC and Laying Down Additional Provisions for Immunological Medicinal Products Consisting of Vaccines, Toxins or Serums and Allergens (Brussels, 3 May 1989).
5. EC, “50 Years EU Pharmaceutical Regulation Milestones,” Public Health Infographic, ec.europa.eu [accessed 22 July 2019].
6. EU, “The History of the European Union,” Infographic, Europa.eu [accessed 22 July 2019].
7. EMA, “History of EMA,” ema.europa.eu [accessed 22 July 2019].
8. EMA, “First General Report on the Activities of the European Agency for the Evaluation of Medicinal Products,” ema.europa.eu, 15 Jan. 1996.
9. EMA, “20th Anniversary of EMA,” ema.europa.eu (Core Media Services UK & Service Point, 2015).
10. A.K. Pau, et al., Infect. Dis. Clin. North Am., 28 (3) 371–402 (2014).
11. P.M. Danzon, A. Epstein, and S. Nicholson, Managerial and Decision Economics, 28 (4–5) 307–328 (2007).
12. A. Gautam and X. Pan, Drug Discovery Today, 21 (3) 379–384 (2016).
13. S.M. Findlay, Pharm. Tech. Eur., 18 (12) (2006).
14. EC, Commission Regulation (EC) No 847/2000, Official Journal of the European Communities (Brussels, 28 April 2000).
15. EMA, “Orphan Medicines Figures,” Presentation, www.ema.europa.eu/en/documents/other/orphan-medicines-figures-2000-2018_en.pdf [accessed 23 July 2019].
16. PharmTech, “Public Health and Economical Risks Mounting as Brexit Uncertainty Continues,” PharmTech.com, 18 Jan. 2019.
17. WHO Regional Office for Europe, “European Health Report 2018: More than Numbers-Evidence for All,” Report, euro.who.int (2018). 

Article Details

Pharmaceutical Technology Europe
Vol. 31, No. 8
July 2019
Pages: 12–14

Citation 

When referring to this article, please cite it as F. Thomas, “Standing the Test of Time,” Pharmaceutical Technology Europe 31 (8) 2019.