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Introduction

The Open University — Wed, 13 Jul 2011 08:49:05 GMT

This unit is from our archive and it is an adapted extract from Strategic management in life sciences and healthcare (BS811) which is no longer in presentation. If you wish to study formally at The Open University, you may wish to explore the courses we offer in this curriculum area.

This unit looks at human healthcare concentrating on the life sciences sector. You will see the historical development of the pharmaceutical industry and examine the relevant management strategies used.

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Learning outcomes

The Open University — Wed, 13 Jul 2011 08:49:05 GMT

After studying this unit you should:

understand the scope of the study of Life Sciences and its history for managers.

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1 What does ‘life sciences’ mean?

The Open University — Wed, 13 Jul 2011 08:49:05 GMT

During the twentieth century, particularly in its second half, the provision of human healthcare changed significantly because of scientific and technological developments. Before then, medical practice was limited and scarcely differentiated from other trades; in fact, barbers often acted as surgeons or dentists. Throughout the 1900s, there were major advances in most countries in sanitation, nutrition, vaccination, surgery, medicines and medical devices. At the same time, there was an increasing provision of specialist facilities (hospitals and clinics) and a greatly increased supply of trained healthcare specialists (doctors, nurses, dentists, etc.) as well as great progress in the availability of useful tools (such as drugs, diagnostics, medical devices and equipment).

As a result of all these advances, life expectancy increased sharply in many countries. By the late twentieth century, economically developed countries typically devoted around 10 per cent of GDP to healthcare and this was tending to increase year-on-year. On the other hand, less developed countries were (and still are) seldom able to spend even that proportion of their much smaller incomes.

Thus a large sector, which includes profit-making companies, charities and government-funded organisations, has grown up under this health banner and you need to be clear about what this sector entails. One way of starting to impose structure on the healthcare sector is to carry out a stakeholder analysis.

Activity 1

Compile a list of stakeholders that you believe are relevant to the life sciences sector. Organise your list to show groups of similar or related players and identify the key relationships among these groups.

You might return to this analysis in the course of this unit and occasionally add to or refine it.

Discussion

You probably identified at least the patient, medical professionals (doctors, nurses, radiologists, etc.) and suppliers (drug companies and manufacturers of scalpels, bandages, diagnostic tests, electrocardiograph machines, etc.) You may also have included the government and insurers in your list. However, a full analysis has to take account of complex issues such as the following.

What is meant by the term ‘patient’? Is a patient defined only by illness or should we recognise that everyone is a potential patient? Is the aim of a healthcare system to treat sick people or to prevent them from becoming sick, or a combination of these? What is the role of patient pressure groups? Many patients regard themselves as perfectly fit but need vaccination for travel or a medical check-up for a job, for example.
If you included the Government in your stakeholder list, what is its role? Is it there as a source of funds for basic research, or as a regulator approving new products, or as a purchaser of drugs and devices, or as a provider of healthcare through owning hospitals, or as a custodian of competition between companies, or as a guardian of the movement of goods between countries?
What is the role of international agencies such as the World Health Organization?
Key industries such as the pharmaceutical industry are obvious but would you include suppliers of more conventional goods to the healthcare system such as blankets and sinks? What about the industries that supply the pharmaceutical industry with its raw materials or machinery?

These examples suggest that stakeholder analysis is not a simple activity and requires considerable thought to organise the information. You may also have realised that the exact shape of a stakeholder analysis might well look very different depending on the purpose behind it. An analysis that suitably describes the situation in the USA may not necessarily be the same as one describing the situation in Germany or France or in a developing country such as Thailand.

Similarly, analysing the situation from different perspectives will give alternative views. Consider the four perspectives of:

a patient (‘I'm sick and want to be better’);
a pharmaceutical company (wants to make sales to earn a satisfactory return on invested capital);
a doctor specialising in a particular disease (wants to do research to find improved methods of caring for patients in the future);
a hospital administrator whose competence is assessed by a non-clinical measure (such as the length of a hospital's waiting list).

Each perspective will lead to a different view of the healthcare system. Yet, in many (if not all) cases, there is a mutual interdependence between certain stakeholders. In fact, pharmaceutical companies and doctors need sick people although, as far as the patient is concerned, being one is not an attractive prospect. Doctors want patients in hospitals as long as is needed to treat them; administrators want them treated quickly so that other patients can be admitted.

Activity 2

Critically reappraise your stakeholder analysis. Look at it freshly from the four different perspectives suggested above and, for now, in the context of your own country (recognising, for consideration later, that there are alternative country contexts that, as a manager, you may need to be aware of).

In constructing this unit, we made certain assumptions about the boundaries of the relevant industry and, therefore, the relevance of the material that should be included. Clearly, many of the players discussed above would be included in any analysis of healthcare and, therefore, enter the issues of management in healthcare and the life sciences. However, in the following peripheral areas the boundary definition is not so clear cut.

Should a discussion and debate about the development and marketing of drugs that are prescribed by doctors also include over-the-counter (OTC) medicines that you can buy from a pharmacist (although the products available OTC may differ greatly between countries)?
Should products which could be called nutraceuticals, supplements and cosmeceuticals be included? (If you are unfamiliar with these categories, you should find definitions of them.)
What should be our attitude to acupuncture, homoeopathy, herbal medicines, and so on?
When considering devices, should healthcare products include some everyday items used in hospitals (pencils, oxygen cylinders, telephones and computers) or should they be excluded because they have no obvious medical function in the same way that scalpels and syringes do? Yet, heart-disease monitoring systems use telephones and/or the internet to report a patient's condition to a doctor at regular intervals.

We need to think very clearly about definitions here. One approach is to note that new medicines can only be marketed (in most countries) if they have been through a formal approval process. In general, the manufacturer must demonstrate that the proposed product is safe and efficacious. To demonstrate the last attribute, extensive trials must be carried out in which the agent is carefully compared with a placebo or with the best existing standard of care. In this unit, we shall adopt as a boundary test the idea that any substance that has passed such tests can be assumed to be a medicine (or drug); such drugs can be made available to a patient by a doctor writing a prescription. Later, after an extended history of safe use, some drugs may be granted a more relaxed regime and be approved for sale as OTC products. Thus, when discussing the markets for drugs, the research and development (R&D) process that has led to them and the strategic management issues faced by their manufacturers, we mean products that have been subjected to such tests.

So, one way of defining the boundaries of what we mean by the healthcare sector is to focus on organisations involved in the supply (and purchase) of healthcare goods and services that are subject to some form of regulation. Clearly, this includes industries involved in manufacturing drugs and devices (discovery, development and delivery) and those within healthcare systems concerned with decisions relating to their purchase – including the patient.

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2.1 Early beginnings – From magic to medicine

The Open University — Wed, 13 Jul 2011 08:49:05 GMT

The life sciences sector, and its precursor the pharmaceutical industry, has a long and rich history. Pharmaceuticals, which are defined as compounds manufactured for use as medicinal drugs (remedies), date back to 2735 BC and the Chinese Dynasty of Shen Nung. Their development can be traced through ancient Hindu, Egyptian and Mediterranean civilisations. The word ‘pharmaceutical’ originates from the Greek pharmakon, meaning ‘drug’. In this early period, responsibility for healing, remedy and repair of human health rested with a wide range of practitioners. They ranged from the spiritual to the secular, using an equally wide range of potions from mystic brews to the natural compounds that underpin many of today's modern medicines.

Pharmaceutical practice improved markedly in the sixteenth and seventeenth centuries with the appearance of well-defined instructions for preparing drugs in terms of both the required constituents and the concentrations. This activity centred mainly on Basel in the 1500s and London in the 1600s, two centres that are still home to some of the largest pharmaceutical companies in the world.

The so-called modern pharmaceutical industry dates back to the nineteenth century with the discovery of manufactured medicinal compounds, which replaced herbal medicines. In the nineteenth century and the early decades of the twentieth century, pharmaceutical companies primarily produced and marketed. They did little research, leaving that to individual scientists or small groups of researchers (Ganellin, 1989). The German chemist Felix Hoffman (1868–1946) is often regarded as the leader of this phase of the industry. In 1897 he discovered a way of adding a cluster of two extra carbon and five extra hydrogen atoms to a substance extracted from willow bark. The result was named acetylsalicylic acid, known by most people today as ‘aspirin’.

Advances in pharmaceutical research characteristically involve scientists, working as individuals or more often in teams, using state-of-the-art technology in order to push the frontier further. Yet the three fundamentals of such research remain as true today as they did in Hoffman's time: (1) ‘discovery’ or pushing the frontier of knowledge to identify potential remedies or treatments; (2) determining more precisely the dosage to be delivered to the target tissue while minimising undesirable side-effects; and (3) ‘Mailing’, to eliminate or reduce undesirable side-effects.

Activity 3

You should now read ‘The global pharmaceutical industry – a case study’ by Sarah Holland and Bernardo Batiz-Lazo, which is attached as a pdf document below (click 'View document' to open; PDF, 0.3MB, 17 pages). This provides a useful summary of the history of the sector and its current situation. Read it with the objective of identifying the problems and limitations associated with the recent history of the sector.

View document

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2.2 Modern history – an evolution

The Open University — Wed, 13 Jul 2011 08:49:05 GMT

So, what is modern about ‘modern medicine’? Several key scholars – notably Schwartzman (1976), Gambardella (1995), Galambos and Sturchio (1996) and Henderson et al. (1999) – have detected a pattern in the recent development of the industry which may help address this question. According to these scholars, the modern history of the industry can be analysed as an evolutionary process. This may involve changes, which are self-created, or adaptation to discrete technological or institutional changes, which may be regarded as ‘shocks’. Viewed in this way, the modern history of the industry arguably started around 1850, and can be divided into the following three epochs.

Epoch No. 1 (c. 1850–1950) This was characterised by relatively little new product research, which in turn was based on relatively primitive methods and organised in an informal way.
Epoch No. 2 (c. 1950–70) By contrast, this was characterised by relatively rapid rates of new product development based increasingly on formalised in-house research and development (R&D) programmes. These new active pharmaceutical ingredients are usually known as APIs, although the terms ‘new chemical entities’ – NCEs – or ‘new medical entities’ – NMEs – are also used.
This epoch was heralded by early successes in the large-scale development of penicillin during the Second World War. Well into the second half of the twentieth century, doctors would prescribe active ingredients and pharmacists would make up powders, pills and liquids which met these instructions before supplying them to patients with guidance on how much to take and how frequently. However, as the century progressed, manufacturers increasingly pre-formulated products into capsules, tablets, sprays, etc. (and pre-packed them, often as weekly dose sets) with a degree of quality control that a local pharmacist would find difficult to achieve. Thus, the pharmacist's role changed from making up products to stocking them and advising the patient.
During the earlier part of the second epoch, the industry relied largely on so-called ‘random screening’ as a method of discovering new drugs. This involved naturally and chemically derived compounds being randomly screened for their therapeutic effects, first in test-tube experiments, and then on laboratory-based animals. The pharmaceutical companies synthesised APIs and kept a record of them but the numbers were – by later standards – low. Other types of organisations also synthesised APIs: agrochemical businesses often synthesised considerably more. One reason for this was that the agrochemical businesses’ screening systems were somewhat cruder and cheaper to run. These compounds would then be subjected to a process of multiple screening to enable researchers to home in on a promising substance. Random screening worked extremely well for many years. This was partly because of the so-called ‘target-rich’ environment, whereby ‘shots in the dark’ or a ‘scatter-gun’ approach often meant results in the fight against disease and malady. It was also partly because of the absence of a better alternative: there was very little detailed knowledge of the biological underpinnings of specific diseases.
This random approach gave way to a more rigorous science-guided approach to new drug discovery in the 1970s. Both the ‘guided’ and the ‘designed’ approach to research methodology owed much to advances in pure science, notably in the realms of molecular biochemistry, pharmacology and enzymology.
Epoch No. 3 (post-1970) Sometimes referred to as ‘drug development by design’, this is characterised by the use of genetic engineering in the discovery and production of new drugs. In 1973, Stanley Cohen and Herbert Boyer (at the University of Stanford and the University of California in San Francisco respectively) demonstrated that a single gene can be moved from one species to another. This is commonly acknowledged as the key scientific discovery that led to modern biotechnology.
There are at least three separate strands in this third epoch:

the pharmaceutical companies experienced a period of consolidation;

a totally different kind of company emerged to work with biological products and systems rather than using chemicals – i.e. biotechnology companies;

pharmaceutical companies largely ignored biotechnology for about 20 years and they have only really interacted since 1995.

Figure 1 depicts the three epochs, including some of the milestones along the evolutionary path of innovation. These scientific epochs were paralleled by organisational developments as early small companies grew, changed, amalgamated and then were acquired or broken up. Your reading of the article by Holland and Bátiz-Lazo will have identified some of the key features of this organisational – and commercial – history.

Figure 1 Chronology of major milestones in pharmaceutical innovation. Source: adapted from Boston Consulting Group, 2005

Long description

This is one history that stresses the process of scientific development; there are others. One important feature of the life sciences sector is the effort to control and define the way it is perceived. We will show repeatedly that the companies in the sector attempt – with resources and resolution – to control the way the sector is seen by governments, patients and healthcare professionals. An example of this is how the sector defines and costs the process of discovery. So, any history of the sector is only one of several possible histories.

Many of the scientific, organisational, strategic and commercial elements of the recent history of the sector are revealed in Box 1. This story illustrates the situation for pharmaceutical companies towards the end of the second epoch – just as the first tentative steps in biotechnology were being taken.

Box 1 Fisons

This British company was founded in the first half of the nineteenth century to supply fertilisers to farmers in the East of England, where a high proportion of the country's cereal crops is still concentrated. Indeed, for many years the company's slogan was ‘The Farmer's Friend’. It was successful for a long time and took over literally dozens of smaller manufacturers so that it became, with ICI, one of the two leading UK suppliers of fertilisers, with its own manufacturing plants in Immingham, Avonmouth and Ipswich. In terms of Porter's Generic Strategies (Porter, 1980), it was a differentiator, rather than a least cost supplier, in the UK market (where freight costs militated against significant imports for most of the company's life). Diane Montagu has summarised the history of the company's involvement in the field in a book reviewing British agriculture (Montagu, 2000).

As spare cash was generated from the fertiliser business, the company also acquired small companies in other industrial fields (an example of diversification in the language of Ansoff's Matrix (Ansoff, 1965)). It acquired an agrochemical specialist – Pest Control – which operated a contract crop-spraying service in the UK and some other countries such as the Sudan. A horticultural business, selling fertilisers, peat, compost and pest control chemicals for use in house and garden, was established. It also purchased laboratory supply companies and a number of companies selling pills, tonics, shampoos and similar products. By the late 1960s, the company had been organised into three main divisions (Fertilisers, Agrochemicals and Pharmaceuticals) and had expanded its research efforts in both agrochemicals and Pharmaceuticals. Geographically, Fisons was still largely a UK company but it had operations of some size in many ‘British Empire’ countries, such as Canada, South Africa and Australia, as well as joint ventures with some large local companies in India.

By the beginning of the 1970s, both the research-based divisions had discovered APIs and were pursuing active development programmes to bring them to the market. The Agrochemical Division had a new herbicide for sugar beet (ethofumesate) and a new insecticide for public health and agricultural uses (bendiocarb), while the Pharmaceutical Division was working with disodium chromoglycate (DSCG), a new type of drug for managing asthma. DSCG was given the trademark Intal^®. It was administered through a special device, known as a Spinhaler^®, to apply the product to the deep lung regions. (You should note that similar drug-device pairings have become increasingly common and many other examples will be given elsewhere in the course.)

In seeking to commercialise Intal, Fisons faced several strategic problems. There were issues at the corporate level as well as at the business unit level, i.e. the Pharmaceutical Division. At the company level, it was recognised that the fertiliser business was becoming steadily more commoditised and the company was not the lowest-cost producer in the UK, let alone in Europe.

At the business unit level, the Pharmaceuticals activity was largely concentrated in the UK and the level of international exposure was low: the countries where there was experience (primarily the UK, Canada and Australia) accounted for only about 5 per cent of the world market for Pharmaceuticals. Moreover, the product range consisted of over-the-counter (OTC) products; there was no prior history of marketing a prescription pharmaceutical product (OTC products are advertised and stocked on pharmacy shelves while the scientific merits of a prescription medicine have to be explained to doctors).

At the same time, the Agrochemical Division was also expanding rapidly (and consuming cash) with operations in at least 12 overseas countries, and a newly formed Scientific Equipment Division was being built by acquisition.

Activity 4

You should now think about the strategic issues that Fisons faced during the 1970s, its strategic responses and the possible outcomes, before going on to the next section. Make notes on the strategic options that were available to Fisons at that time; think particularly about how the company might try to address the international introduction of Intal.

Separate your thoughts for the business unit level and for the corporate level; concentrate mainly on the former.

Discussion

At the business unit level, it seemed essential to move rapidly to establish the product in the global market-place and this inevitably meant some significant steps. The first steps were needed in the countries where the business was established and these can be thought of in terms of adjusting the resources and capabilities it could deploy. This could then be followed by an international expansion, which can be considered using the Ansoff Matrix concept of market development.

So Fisons chose to:

dispose of a significant part of its older OTC ‘pharmaceutical’ products (raising cash);
retrain its quite large UK sales force to handle a prescription product and recruit some specialists with prior experience;
set up small sales and marketing organisations in selected European countries (France, Germany and Spain, for example);
seek partnerships in the USA and Japan.

In Japan, Fisons appointed the local company Fujisawa to market Intal on its behalf (this became a successful long-term partnership). In the USA, it decided to grant marketing rights to a company called Syntex, provided that the latter used its own brand name of Aarane^®, while Fisons retained the right to use the name Intal and to make some sales itself through a small sales force of its own. (Syntex is famous for introducing the birth-control pill but is no longer an independent company; it was purchased in 1994 by Roche, the Swiss pharmaceutical giant, for US$5.3 billion.) However, the possibility of Syntex withdrawing from the arrangement some two years later (after loading the distribution chain) because it had other priorities was not anticipated; having to enlarge the US Fisons-owned business to replace that loss was costly. The costs of building sales forces in other countries and in maintaining a large R&D effort meant that there was a continual need for cash. Nevertheless, Intal was a considerable success as an asthma treatment and was very profitable. Fisons also developed the active ingredient for closely related allergic conditions affecting the nose and eyes in addition to its primary use in the lungs (the Ansoff Matrix concept of product development is relevant here).

At the corporate level, there was a determination to support the Pharmaceutical Division; it was perceived as the best chance to secure an international future for the group. However, the steady stream of earnings from the historical base business (fertilisers), which had fuelled the earlier acquisitions, was becoming less certain and there were also constant needs to refurbish old plant in that business. The concern was whether there would be sufficient financial resources available to cover the R&D costs of the other two divisions before they became really profitable and to support the building, by acquisition, of a fourth Division (Scientific Equipment). The strategic aim was to have a portfolio of four businesses (this was in the days when diversification, as in the Ansoff Matrix, was more common than was the norm later).

This was all happening in a broad UK economic context of high inflation, Government-imposed price and wage controls and low economic growth, which reduced the stock market valuation of many companies (with the consequence that it was difficult to raise new money). Moreover, the expected retirement of the Group's Managing Director from his executive role led to indecision about the managerial succession.

Although the company continued for several more years, surgery was required. By 1983, the Fertiliser and Agrochemical Divisions had both been sold (the former to Norsk Hydro and the latter to Schering; note that Bayer has since acquired all the agrochemical interests owned by Schering plus those owned by Hoechst and Rhone-Poulenc). Fisons’ remaining businesses continued, and grew quite rapidly, until the early nineties when support from the financial community was largely exhausted, not least because the flow of new drugs was considered disappointing. In the mid-eighties the acquisition of Pennwalt, a US manufacturer of pharmaceuticals, including some very successful OTC products, did not provide an answer. A rapid and complete disposal programme ensued in 1992/3 and the company effectively ceased to exist, although many of its products are still marketed by successor companies.

Before leaving the history of the life sciences sector we need to consider the future. For now, we shall simply note that, whatever this future (or these futures) hold, it is bound to require a balance or an accommodation among several powerful but very different forces, which are in varying degrees of opposition or tension. One force or trajectory is scientific development, which supplies the critical underpinning to the sector and operates at least through the areas discussed here: drugs, devices and diagnostics. Another key trajectory is the actions and attitudes of governments, not only as purchasers and regulators but also as bodies concerned about issues of public health. A third force is the economics of the sector: the performance of the companies and the strategies they adopt in the face of the pressures and opportunities that arise. The final force is public opinion.

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2.3 The life sciences sector in perspective

The Open University — Wed, 13 Jul 2011 08:49:05 GMT

Before leaving the ‘big picture’ of the evolution of the pharmaceutical industry, it is important not to give the impression that it is the sole, or necessarily even the central, player in health provision. As in any other industry, it can contribute only because it operates in a wider sphere populated not only by other institutions and organisations but also by more amorphous socio-political ambitions, values and beliefs. For example, the medical technology industry facilitates health by providing diagnostics and devices: the Government facilitates healthcare by financing it. Equally important, perhaps, but less tangibly, there is public acceptance of the desirability of improving health. Consider also those industries that could facilitate health by disappearing: for example, the tobacco industry and the arms industry.

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Next steps

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After completing this unit you may wish to study another OpenLearn Study Unit or find out more about this topic. Here are some suggestions:

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References

The Open University — Wed, 13 Jul 2011 08:49:05 GMT

Ansoff, H.I. (1965) Corporate Strategy, Penguin, Harmondsworth.

Galambos, L. and Sturchio, J. (1996) ‘The pharmaceutical industry in the twentieth century: a reappraisal of the sources of innovation’, History and Technology, Vol. 13, pp. 83–100.

Gambardella, A. (1995) Science and Innovation in the US Pharmaceutical Industry, Cambridge University Press, Cambridge.

Ganellin, C. (1989) ‘Discovering new medicines’, Chemistry and Industry, 2 January, pp. 1–7.

Henderson, R., Orsenigo, L. and Pisano, G.P. (1999) ‘The pharmaceutical industry and the revolution in molecular biology: exploring the interactions between scientific, institutional and organisational change’, in D.C. Mowery and R.R. Nelson (eds), The Sources of Industrial leadership, Cambridge University Press, Cambridge.

Montagu, D. (2000) Farming, Food and Politics, Irish Agricultural Wholesale Society,

Porter, M. (1980) Competitive Strategy, The Free Press, New York.

Schwartzman, D. (1976) Innovation in the Pharmaceutical Industry, Johns Hopkins University Press, Baltimore, MD.

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Acknowledgements

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Except for third party materials and otherwise stated (see terms and conditions), this content is made available under a Creative Commons Attribution-NonCommercial-ShareAlike 2.0 Licence

Unit Image

Sloppy Stephen: http://www.flickr.com/ photos/ stevehau/ 64664105/.

Text

Holland, S. and Batiz-Lazo, B. (2004) ‘The Global Pharmaceutical Industry’, Johnson, G. and Scholes, K. Exploring Corporate Strategy, Seventh Edition, 2004. With the permission of Pearson Education Limited.

All other materials included in this unit are derived from content originated at the Open University.

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