In this section, the development of the South African pharmaceutical industry is discussed in three sub-sections. The first is the period of localized manufacturing before liberalization, the second involves some deindustrialization under liberalization as global pharmaceutical production has been consolidated elsewhere, and, finally, the third documents the growing orientation towards imports of finished products. The various state responses to deindustrialization and import growth in terms of how to promote ‘better’ development outcomes are then outlined in the following section.
Local Pharmaceutical Formulation Manufacturing Pre-liberalization
The modern pharmaceutical industry in South Africa grew from retail pharmacists who initially dominated the industry in the late 19th and early 20th century. Appointed as local distribution agents for foreign firms, they mostly imported finished products from abroad, although some also ventured into very basic manufacturing. For example, what is now South Africa’s largest pharmaceutical company, Aspen Pharmacare, traces its roots to Lennon Ltd., a pharmacy established in Port Elizabeth in 1850. The second largest South African pharmaceutical firm today, Adcock Ingram, traces its origins to the E.J. Adcock Pharmacy, which opened in Krugersdorp in 1890.
Local pharmaceutical formulation manufacturing expanded from the mid-20th century in South Africa in a context where pharmaceutical MNEs, there and elsewhere, often established manufacturing plants alongside marketing, sales, and distribution functions. World War II led to an increased demand for medicines and expansion of local manufacturing in the country (Ryan, 1983: 87). For example, Adcock Ingram opened its first manufacturing facility at Aeroton in 1940 and increased its scale with a licensing agreement from Baxter in 1948. By the end of the 1950s, 70% of medicines were imported and there were 32 subsidiaries of foreign MNEs and 33 foreign companies locally represented by agencies or distributors (Davenport-Hines & Slinn, 1992: 317). Examples of MNEs that opened plants include Glaxo in 1954 at Wadeville Germiston (Davenport-Hines & Slinn, 1992: 319–320), Pfizer in 1968 at Pietermaritzburg (Pfizer South Africa, 2020), and what is now Sanofi-Aventis in 1972 at Pretoria (Sanofi South Africa, 2020). In an example of locally-owned manufacturing, South African Druggists took over Lennon Ltd. and, on a site in Port Elizabeth where it had been in operation since approximately 1940, significantly upgraded its manufacturing and research facilities between 1975 and 1988 (Aspen, 2005: 34). One estimate is that by the 1980s, approximately 45 pharmaceutical manufacturing facilities were present in South Africa (Focus Reports, 2012: 15).
The manufacturing aspect of the South African pharmaceutical industry has historically overwhelmingly focused on the formulations stage of the value chain, assembling final products from imported active and inactive ingredients (Steenkamp 1979). In a limited example of a move into active pharmaceutical ingredients (API) production, Fine Chemicals was established in Cape Town in 1962, initially targeting the production of codeine phosphate, morphine sulphate, and paracetamol (Fine Chemicals Corporation website, accessed March 3, 2020). Yet, with only 13% of the APIs used in South Africa in the late 1970s being produced locally, and those too requiring imported fine chemicals, there was a considerable overall dependence on imports – even for products where the formulation stage was local (Steenkamp, 1979: 86).
Foreign-owned pharmaceutical MNEs from the United States and Europe dominated the South African pharmaceutical market through most of the second half of the 20th century, benefiting from the huge technological progress (e.g., antibiotics revolution) in the global pharmaceutical industry between 1940 and 1955 (Chandler, 2005; Gereffi, 1983). Of the market for prescription medicines, by the late 1970s, foreign-owned firms had an 85.8% share of the market, led by those from the US (39.2%), UK (18.2%), Switzerland (14.4%), and Germany (7.5%) (Steenkamp, 1979: 76). Multinationals faced lobbying pressure from the anti-apartheid movement to leave South Africa, and although Merck did leave during 1989, many others including Eli Lilly, Johnson & Johnson, Pfizer, Schering-Plough, and Warner Lambert, continued to operate in the country (Prakash Sethi & Williams, 2012).
Multinational-led Deindustrialization and the Emergence of Import-oriented Engagement with GVCs
Since the opening up of the South African economy post-apartheid, the country’s manufacturing industry has struggled to compete, including in pharmaceuticals. Manufacturing value added as a share of GDP, steady at between 19 and 22% of GDP from 1960 to 1990, has fallen from 21.6% in 1990 to 17.5% in 2000 to 12.1% in 2010 and 11.8% by 2018 (World Bank World Development Indicators, accessed March 2, 2020). Within pharmaceuticals, some European and US-owned MNEs have ‘functionally downgraded’ their South African operations out of manufacturing. In the first decade post-apartheid, it is widely estimated that more than 30 pharmaceutical manufacturing plants closed, with the direct loss of 6500 jobs (e.g., Maloney & Segal, 2007: 6). Table 3 below provides examples of some of the closures of pharmaceutical plants in South Africa in the late 1990s. Other companies not listed in Table 3 which closed manufacturing plants in South Africa in the years leading up to and following the turn of the Millennium included AstraZeneca, Novo Nordisk, Schering-Plough, Eli Lilly, Roche, Abbot, and GlaxoSmithKline (Johannesburg factory only) (Maloney & Segal, 2007: 31).
Table 3 Closures of domestic pharmaceutical plants in South Africa in the late 1990s Many pharmaceutical MNEs withdrew from manufacturing in South Africa in order to concentrate production at “centers of excellence” elsewhere, involving large, lower-cost units benefiting from economies of scale and serving global markets (Fridge, 2000: 138; various interviews). Domestic pharmaceutical plants were built in an era of sanctions and involved outdated technology, as well as limited volume capacity (Fridge, 2000: 55). One report found that many respondents from pharmaceutical MNEs believed it would be more efficient to limit manufacturing activities in South Africa to packaging and labeling (Fridge, 2000: 84), while others exited from any manufacturing activity in the country. The small size of the South African market meant that it had little importance in size terms for many MNEs (CEO of Novartis SA, in Focus Reports, 2006: S27). The General Manager of Bayer Healthcare, which shifted to produce all of its over-the-counter and pharmaceutical products for South Africa from Germany, was quoted as saying that companies had scaled down production because “it has become more efficient to import drugs” (Focus Reports, 2006: S27). Deloitte (2007: 21) referred to “the closure of manufacturing plants in the country…. due to the global consolidation of supply chains and centers of excellence”. The concentration of production was augmented by considerable mergers and acquisitions in the global pharmaceutical industry (Maloney & Segal, 2007: 31; DTI 2011: 20; also DTI, 2014: 94). As well as their presence declining, foreign MNEs' reputation was also especially damaged by a high-profile and controversial legal challenge (launched in 1998 and eventually abandoned in 2001) to reforms to South Africa’s Medicines and Related Substances Control Act, which would facilitate generic entry (Horner, 2015).
Although many European and US-owned MNEs consolidated their manufacturing elsewhere, some maintained limited manufacturing presence in South Africa for niche production lines. For example, Roche found South Africa “too small to qualify” as a center of excellence (Deloitte, 2007: 38), but decided to manufacture Fansidar in South Africa. Sanofi-Aventis invested R20 million in an expansion of its anti-TB drugs facility in Waltloo/Mamelodi (formerly Noristan Pharmaceuticals) in 2010 (DTI, 2011: 22), while GSK upgraded its Albendazole plant in Cape Town (DTI, 2011: 21).
Table 4 below outlines 26 companies with local manufacturing in South Africa, involving a total of 32 plants, in 2011. Such manufacturing plants varied in employment from 20 (Bioclones and Gulf Drug Co.) to 2500 (Aspen-Pharmacare in Port Elizabeth) (DTI, 2011: 19). This is a considerably smaller number of plants than had been present during the apartheid era, and many of those plants which remain are widely estimated to operate well below full capacity (e.g., Focus Reports, 2006: S27; Pharasi et al., 2010: 80; Interview, Cape Town, February 27, 2019). A 2018 estimate for the number of direct jobs in the manufacturing segment of the industry is 9600 (DTI, 2018: 141).
Table 4 Pharmaceutical manufacturing in South Africa, 2011 Some locally owned firms moved into the market space, and sometimes physical plants, where foreign MNEs had been operating and have become the largest firms in the South African pharmaceutical market through acquisition. Adcock Ingram acquired parts or all of Baxter, Dow-Chemicals Africa, Restan Laboratories, Stirling Winthrop (all in the 1980s), Leppin, Laser, Pharmatec, Zurich Pharmaceuticals, Covan Pharmaceuticals and Salters (in the 1990s) and Parke-Med (Pfizer’s generic business in 2003). Aspen took over South African Druggists in 1999 (which had a manufacturing site at Port Elizabeth), a company which in turn had acquired Lennon Ltd. in the 1970s, and the API-producer Fine Chemicals in 2004. Local contract manufacturers, such as Wrapsa founded in 1983 and PharmaQ similarly in 1998, have also filled some of the void left by companies who have ceased to manufacture in their own name in South Africa.
The almost complete absence of manufacturing presence in the API stage of the value chain in South Africa, owing to constraints of scale and cost, has been a constraint on the expansion of formulations production. The lack of API production was referred to as “the ‘Achilles heel’ of South Africa’s pharmaceutical industry” (Kudlinski, 2011). Local API production has always been limited in South Africa, with the Cape Town-based, Aspen subsidiary, Fine Chemicals the main manufacturing presence in South Africa in this segment of the value chain. One estimate from 2011 was that at least 95% of the APIs were sourced through imports (DTI, 2011: 19). Lack of greater local API production in South Africa has been attributed to “fierce competition from low-cost Indian and Chinese imports” (DTI, 2014: 95). In addition, the lack of economies of scale in South Africa is a major constraint (Fridge, 2000: 57). API production is specialized according to different drugs, with many API factories needed for a portfolio of drugs (Maloney & Segal, 2007: 63). One interviewee from a contract manufacturing company explained that “the market is too small for APIs in South Africa”. Illustrating with an example, the interviewee stated that “You can buy paracetamol way cheaper elsewhere. You have to produce millions of tons of the stuff. You will never in South Africa” (Interview, Centurion, October 27, 2014).
Due to the reliance on imports for APIs and other imported inputs, even drugs where the final formulation manufacturing takes place in South Africa involve considerable foreign value-added (Maloney & Segal, 2007: 96). One estimate was that typical costs for a product manufactured in South Africa were 40% domestic (e.g., labor, utilities, overhead) and 60% international (90% of that being APIs, the rest being other imported inputs, e.g., packaging materials), although in some cases (e.g., anti-retrovirals (ARVs)) the international costs could rise to 80–90% (Maloney & Segal, 2007: 94). Another estimate of the extent of local content suggested it varies between 10 and 20% where only packing activity takes place locally, 40–70% for finished formulation based on imported API (40 and 70%), and 90%+ for large-volume parenterals (DTI, 2011: 24). With the reliance on imports, including of inputs, the industry has also suffered from exchange rate depreciation (e.g., Focus Reports, 2012: 12). Domestic producers face tariffs on APIs, while a producer outside South Africa may not and may be able to import a formulation tariff-free (Maloney & Segal, 2007: 96). With such an extent of imported inputs, some interviewees thus questioned how ‘local’ local manufacturing really is (e.g., Interviews, Midrand, July 16, 2014; Sandton, October 31, 2014).
The Consolidation of Import-orientation with Indian Generics
With the liberalization of the economy, South Africa has struggled to export pharmaceuticals and the reliance on imported products, which can enter tariff-free (DTI, 2018: 142), has grown. South Africa’s trade deficit in pharmaceuticals (finished formulations, HS3004) has increased from US $485.3 million in 2001 to US $1436 million in 2019 (Source: ITC Trade Map, 2020), and has been projected to increase further (BMI Research, 2019: 20). The monetary value of imports was almost six times that of exports in 2018 (BMI Research, 2019: 20). Most manufacturing companies interviewed reported doing very little exporting from South Africa. That which does take place both draws on significant levels of imported inputs (e.g., Fridge 2000, 48; Maloney & Segal, 2007: 17) and is small in value, targeting the regional market. Of finished drugs sold in the domestic market in South Africa, the imported share increased from 15% in 1990 to 30% in 2000 (Fridge, 2000: 168). By 2006, imports were estimated at 41% of the value of the local market, with 59% formulated locally (Maloney & Segal, 2007: 28).
With European and American MNEs largely concentrating production at centers of excellence elsewhere, competition from India has been widely cited as the major competitive challenge for that formulation manufacturing which remains in South Africa. India is the number one source of imports of pharmaceutical formulations into South Africa. Figure 2 demonstrates India’s growing share of South Africa’s imports of pharmaceutical formulations. The then Director of Pharmaceuticals at the DTI acknowledged that India is not the biggest contributor to the trade deficit when compared to aggregate imports from Europe and the USA, but argued it is the biggest competitor to domestic manufacturing:
“The major contributor to the imports burden are imports of innovator and branded products from Europe and the USA. There is little competition with the domestic industry in this market segment. India, which tops the list of importers, is the supplier of generic medicines and competes directly with the domestic industry” (Kudlinski, 2013: 271).
The DTI has claimed that the South African pharmaceutical industry “can compete against imports from any country except India” (DTI, 2011: 4). The introduction of mandatory generic substitution in 2003 was influential in the subsequent shift in composition of the South African industry toward generics (Gray, Suleman, & Pharasi, 2017), a segment of the industry where India has considerable expertise (Athreye, Kale, & Ramani, 2009; Chaudhuri, 2005; Horner, 2014; Joseph, 2016). One South African policymaker commented on India’s pharmaceuticals, “they present an image as missionaries, the ‘pharmacy of the developing world’. It's fantastic for ARVs, but at the same time they’re undermining the capacity of our generic industry” (Interview, Pretoria, July 24, 2014). Another South African policymaker even went as far as to say that, in pharmaceuticals, the “Indian industry has killed off South African industry. There’s no doubt” (Interview, Cape Town, February 27, 2019).
Many companies supplying generic pharmaceuticals rely almost exclusively on imports of finished formulations, especially from India, with little or no manufacturing and only registration and marketing presence in South Africa. As relative exceptions, both Cipla and Ranbaxy (now part of Sun Pharmaceuticals) have manufacturing presence in South Africa, having acquired and upgraded plants from other companies exiting manufacturing. Although the former only fully acquired Cipla-Medpro in 2013, it had a distribution relationship with Medpro since the 1990s, and took over a manufacturing plant of the British-owned MNE Reckitt and Benckiser in Durban in 2005. Ranbaxy began selling products in South Africa in 1997 and acquired Be-Tabs, a South African firm established at Rooodeport in 1974, in 2007. However, they are part of a very small minority of Indian-owned firms which have established manufacturing in South Africa. For strategic reasons, as well as local regulatory requirements, many Indian firms formed partnerships with local entities for marketing, registration, and distribution. One interviewee explained how difficulties in market access meant Indian firms “joined hands” with local firms (Interview, Johannesburg, October 29, 2014). Another suggested that while Indian companies specialized in manufacturing, “local expertise and local knowledge” was crucial for sales and marketing (Interview, Sandton, July 23, 2014). Finally, a number of interviewees explained the benefits of local partnerships included addressing concerns around Indian medicines, especially regarding the quality (e.g., Interview, Centurion, July 17, 2014; also Interview, Midrand, October 30, 2014; Interview, Cape Town, July 30, 2014).
A wide range of interviewees emphasized the importance of sourcing from, and having relationships with, firms in India, especially for those that do have local manufacturing presence in South Africa. One interviewee explained that 70% of their sales value is imported from India and the rest is manufactured locally, although indicated that his company:
“would actually like to move what we do locally to India. I’d like someone else to worry about the manufacture. I’ve got my headache around here trying to chase people. So manufacture isn’t a key business for me” (Interview, Midrand, July 18, 2014).
Another interviewee from a South African firm with Indian ownership suggested “every single company in SA has some or more products from India or some or more content from India” (Interview, Sandton, October 30, 2014). Yet another explained that “I don’t think there’s a single company in South Africa that’s not involved with India…. They’re here to stay” (Interview, Pretoria, November 3, 2014; also Interview, Cape Town, July 30, 2014). The CEO of a South African firm with ties to India simply said: “If you’re in generics, you’ve got to have Indian partners” (Interview, Midrand, July 22, 2014). Although Aspen and Adcock Ingram have invested directly in India (Gelb, 2014), for the most part South African firms have sourced from and formed ties with companies in India to leverage Indian production. The managing director of a company which contract manufactures from India referred to a visit to India in the late 1990s or early 2000s:
“When I walked through those Indian factories, the level of innovation, the technology was 5–10 years ahead of SA. And that’s when it hit me, that it would take us a huge amount of capital investment to get our factories to that level to compete on the same level. So I thought it’s not gonna happen.…. So I mean at that point, I thought I don’t think we can beat them. If you can’t beat them, join them” (Interview, Johannesburg, July 15, 2014).
Interviewees identified a number of constraints for pharmaceutical firms manufacturing in South Africa. For example, the Country Head (for South Africa) of another Indian firm suggested that “They’d rather make it there and send it here. that’s the issue. …They err on the side of importing because it’s more cost-effective” (Interview, Midrand, July 16, 2014). Input costs such as water, electricity and labor were pointed to as higher in South Africa (Interview, Sandton, July 23, 2014). Moreover, some interviewees noted that the South African market appears relatively small for some Indian companies, not offering significant volumes for greater front-end investment (Interview, Midrand, July 18, 2014; Interview, Centurion, July 16, 2014). The CEO of an industry association group said succinctly, in relation to India, “they’ve got scale and here we don’t” (Interview, Midrand, July 16, 2014). With much larger volumes, a related advantage is the full range of related industries in India, especially presence in the API stage of the value chain. For example, the Managing Director of an Indian-owned firm in South Africa observed that in India “equipment, APIs, packing materials, everything is locally available. For SA today, we don’t have that. We don’t have any major bulk drug companies” (Interview, Johannesburg, October 29, 2014; also Interview, Pretoria, November 3, 2014). While some representatives of South African-owned firms suggested importing Indian firms benefited from greater state facilitation compared to local companies, through tax incentives (Aspen, 2010: 7), representatives of Indian companies did not acknowledge any such benefits (Interview, Midrand, July 24, 2014; NAPM, 2010: 17).
The trends outlined in this section – of both the decline of manufacturing in South Africa by MNEs and increasing import reliance – are both products, to a considerable degree, of the liberalization of the South African economy and concentration of production for GVCs elsewhere. The next section explores how the South African state has sought to promote better development outcomes in this context.