Regulating Anti-Competitive Practices in the Pharmaceutical Sector: Whose Job?

1. Regulating Anti-Competitive Practices in the Pharmaceutical Sector: Whose Job? Erlinda M. Medalla Melalyn C. Mantaring Hanoi, August 2005

2. Medicines as % of Total Health Expenditure 2000 Can’t pay, won’t get• Fully a third of the world’s people cannot afford essential drugs.• In the poorest countries of Africa and Asia, half the population does without.• In the rich world, under 40% of medicines are bought privately compared to 67% in sub-Saharan Africa and 81% in Asia and the Pacific

3. The Pharmaceutical Industry

4. Key Features of the Pharmaceutical Industry • comprises the discovery, development, production, distribution, marketing of prescription drugs and • characterized by: • highly risky and lengthy R&D process, • intense competition for intellectual property, • stringent government regulations • powerful purchasers pressures (e.g. government, insurance companies, patients as the final consumers)

5. Four Broad Types of Industry Players • Prescription-only or ethical drug companies • producers of branded prescription drugs require strong R&D and global sales and marketing infrastructure • Over-the-Counter (OTCs) • branded OTC drugs demand direct-to consumer (DTC) marketing capability • Generics companies • focus on supply chain management and manufacturing cost leadership • Biotechs • must create and defendintellectual property in specialized research fields

6. Prescription-only or “ethical” drugs comprised about 80 percent of the global pharmaceutical market by value and 50 percent by volume Ethical products divide into conventional pharmaceuticals and more complex “biological” agents and vaccines The remainder were “over the counter” medicines (OTCs), which may be purchased without prescription Both ethical and OTC medicines may be branded or “generic” Prescription-only vis-a-vis OTC drugs

7. Pharmaceutical Producers World-wide, a large number of firms are engaged in the production of pharmaceuticals and it is possible to divide these firms into two classes or tiers according to their level of investment in R&D: • 1) relatively small number of global firms are responsible for the R&D and consequently dominate the market for patent-protected prescription drugs • roughly 100 global firms originate mostly from the US, Germany, Switzerland or the UK • they perform most of the R&D of the world’s pharmaceutical industry and dominate the market for prescription drugs • 2) large number of small firms producing mostly for local or national markets, holds fewer patents, relying primarily on manufacturing off-patent “generic” medicines • very little R&D is undertaken, which to a large degree is dictated by the technology of pharmaceutical R&D and production

8. The World’s Largest Pharmaceutical Companies • For these companies competition is not primarily on the basis of price but rather on the basis of marketing and innovation • These companies compete to develop entirely new drugs which either treat entirely new medical conditions, improve upon existing drugs, or substitute for existing patented drugs

9. Big Pharma • “Big Pharma”- a dozen or so multinational firms with headquarters in Europe or America, the biggest company, Pfizer, holding less than 10% of the global pharmaceutical sales • The top ten companies each had sales of more than $12.5 billion. • Together they generated $205.42 billion or 44% of the Total Global Pharma Sales

10. Horizontal and Vertical Consolidation in the Pharmaceutical Industry • There has been a significant wave of mergers in the pharmaceutical industry in the last few years • This merger and acquisition process is continuing and is reshaping the industry • A collected mergers have been announced between Pfizer and Warner-Lambert and between Glaxo Welcome and SmithKline Beecham • At the end of 2002 Pfizer acquired Pharmacia

11. Research & Development Expenditures • Pfizer, with nearly $40 billion in sales, spent almost 18% of its prescription revenue - $7.13 billion- on R&D in 2003. • Top 10 companies combined spent $35.98 billion on R&D

12. The Drug Discovery to Commercialization Process • The pharmaceutical industry has long new product lead times, it requires an average of 12 years for a medicine to reach pharmacy shelves from discovery period • Very costly and highly regulated process • Only one out of 5,000 to 10,000 promising substances survives the extensive testing in R&D phase to become approved as a marketable product, with an average of $800 million dollars in R&D cost • When the costs of all the projects that do not reach fruition are considered, it becomes clear that pharmaceutical R&D is a very high stakes game

13. The Drug Development Process

14. From Laboratory to Patient: The Complex Pathway of Biopharmaceutical R&D

15. The Drug Discovery to Commercialization Process • Given the enormous risks and considerable investment involved, it is not surprising that pharmaceutical companies compete fiercely to establish and retain intellectual property rights • Only by securing a patent that can be defended against imitators can be the value of all this R&D be recouped • The patent clock starts the moment that a promising agent is identified in pre-clinical tests and its chemical structure and synthesis filed with patent offices worldwide • Once the patent application is made public, other companies are likely to try to create improved, patentable versions

16. Marketing and Promotion • Once a product is brought to market, pharmaceutical companies spend heavily on marketing and promotion • The typical cost structure at ethical pharmaceutical companies comprises manufacturing of goods (25%), research and development (12 to 21%), administration (10 %), and sales and • marketing (25%).

17. Marketing and Promotion • The larger drug companies maintain a large sales force which makes direct regular contact with individual prescribing physicians and other pharmaceutical decision makers • Between 1997 and 2002, promotion to healthcare professionals in the US doubled to $18.5 billion. • Direct-to-consumer advertising added another $3 billion.

18. 2003 Marketing and Promotion • Given the huge fixed costs of maintaining a sales force, drug companies do not always seek to carry out all their marketing themselves • Instead it is common for companies to enter into arrangements in order to make use of another firm’s marketing expertise • Companies might choose to enter into “co-promotion” agreements where they both agree to produce and sell a drug under the same brand name or “co-marketing” agreements where they both agree to produce and market a drug, but under separate brand names

19. Key Markets • Global pharma sales* accounted for $466 billion in Rx drugs in 2003 • The majority of global pharmaceutical sales originate in the “Triad” (US, EU and Japan) accounting for 85 % of the global market in 2003 • The US has been by far the largest pharmaceutical market by volume and value (half of global sales) * Pharmaceutical sales figures include prescription and certain over-the counter data, and represent manufacturer prices

20. Profitability of Research-Based Pharmaceutical Companies • Profit margins are the highest as compared to other industry even beating even the commercial bank sector (ranked by percentage return on revenues, 2001) • Over a 32 year period (1960-1991) the return on equity averaged 18.4 percent for pharmaceuticals and 11.9 percent for the • 500 largest industrial companies • This is consistent with investment reports that also point to the above average returns earned by pharmaceutical company shareholders

21. Market Share in Individual Therapeutic Classes • The drugs in a therapeutic class are (more or less) substitutes from the perspective of health consumers, therefore often used as a proxy for the competition law concept of the relevant product market.

22. Major Industry Trends • Aging Population Increases Demand for Drugs • Big Pharma steps up R&D Spending • Mergers and Acquisition Reshape the Industry • Biotech Firms Gain Clout in Partnerships with Big Pharma • Direct-to-Costumer Push Proliferate in the US • Internet Emerges as Key Marketing Tool • New Role for Drugmakers: Defense

23. The Pharmaceutical Industry Regulation

24. The Regulation of Drug Supply • Intellectual Property Rights • Generics • The Regulation of Safety and Entry to the Market

25. The Regulation of Drug Demand • The Effect of Insurance on Pharmaceutical Demand • The Response of Health Insurance to its Effect on Demand • The Control of the Quantity and Quality of Pharmaceutical Expenditure • Formularies • Reimbursement Policies • Controls on Prescribing Doctors • Controls on Pharmacists • Controls on Prices • The Pharmaceutical Distribution Chain

26. Competition Issues in the Pharmaceutical Industry • Market Definition • Agreements • Mergers • Abuse of Dominance

27. Concluding Remarks

28. Pharmaceutical Industry Regulation • All aspects of the life-cycle of new drugs are regulated, from patent application, to marketing approval, commercial exploitation, patent expiration and competition with generics • All the important actors in the pharmaceutical industry the manufacturers, wholesalers, retailers and prescribing physicians are also subject to regulatory controls • These regulatory controls pursue three primary objectives: • (a) preserving the incentives for research and development and the flow of new innovative drugs; • (b) ensuring the safety of drugs consumed by the public; and • (c) controlling the quantity and quality of drug expenditures.

29. Pharmaceutical Industry Regulation (con’t) • The combined effect of this regulation is that competition takes a different form than in other industries • On the supply side, the vagaries of the R&D process and the substantial costs and delays of the drug authorization process make new drug development a risky and costly business. But, successful drugs, protected from competition by intellectual property rights, can yield a substantial reward • On the demand side, the presence of ubiquitous health insurance partially insulates final consumers from the prices of the drugs they consume. In their place, public and private health insurers adopt a host of mechanisms for controlling the quantity and quality of drug consumption • The nature of competition in the drug industry is determined by the interaction of both these supply and demand side effects

30. Corporate Social Responsibility • During the 20th century average life expectancy in developed countries increased by over 20 years • A significant part of this improvement can be attributed to pharmaceutical innovation • Few other industries can claim to have done as much for the well being of mankind • Then why the industry becomes an easy target for unpredictable government intevention? • The market for pharmaceutical innovation has the characteristics of a “public good” – i.e. expensive to produce but inexpensive to reproduce • The manufacturing cost of drugs is usually tiny compared with the amortized cost of R&D that led to the discovery • Setting prices that attempt to recoup R&D therefore looks like corporate greed incomparison with the very low prices that can be charged by generic manufacturers • Would prefer pharmaceutical companies to have a social mission • Thus, the pharmaceutical industry needs to be very good at explaining the nature of its business and balancing societal and shareholder expectations, in short companies must balance shareholder return against the huge unmet need of developing nations

31. Public/Private Cooperation: The US example • Major pharmaceutical and biotech firms pay the greatest share of R&D costs, supporting in-house, academic, and smaller biotechnology company research • The government and other for-profit and not-for-profit • institutions also fund some elements of R&D, and all players interact cooperatively to advance discoveries

32. For Patients, Access Equals Impact The last step in the pathway from scientific discovery to use of medicines by people is ensuring that patients have access to successful innovative medicinesThis final link relies on policy rather than R&D to fulfill the promise of today’s expanding scientific knowledge.

33. Public & Private Policies that Improve Access to Innovation • Continue to support the public-/private sector cooperation in research and related policies • Support the implementation of the prescription drug benefit for Medicare beneficiaries, a critical first step in improving patient access focused on America’s seniors and the disabled. • Improve access for uninsured Americans, who often cannot afford the medicines they need • One private-sector response that is making a difference: PhRMA members’ Patient Assistance Programs • Improve access for people around the world • PhRMA members also support global patient assistance efforts by providing free and reduced-cost medicines to developing countries and responding to global health crises • Maintain a competitive market to sustain the investment in R&D • Failed policies such as European-style government price controls and the importation of drugs into the United States from foreign countries greatly reduce the incentives for innovator firms to undertake the long, costly, and uncertain process.

34. Whose Job? • Main Objectives: • Equity and access/ health & safety concerns • Big role for both government and business • Social corporate responsibility • Government provides through IPR some monopoly rights to pharma industries to encourage innovation, nonetheless it still has a role in promoting more competitive market • Public/Private cooperation essential • Information & education/consumer protection