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Journal of Commercial Biotechnology

, Volume 17, Issue 4, pp 308–318 | Cite as

The strength of pharmaceutical IPRs vis-à-vis foreign direct investment in clinical research: Preliminary findings

  • Meir Perez PugatchEmail author
  • Rachel Chu
Original Article

Abstract

This article examines the effect of the intellectual property (IP) environment in developing countries on the level of foreign direct investment (FDI) and technology transfer occurring in the biopharmaceutical field in these countries. In particular, it considers the correlation between the strength of IP protection in several developing countries (using the Pharmaceutical IP Index) and the number of clinical trials taking place in these countries (as a proxy of biomedical FDI). The article finds that overall, the strength of national pharmaceutical IP environments provide a good estimate of the level of clinical trials taking place in these countries. Accordingly, countries with a more robust level of pharmaceutical IP protection tend to enjoy a greater level of clinical trial activity by multinational research-based companies. In other words, by choosing to improve their level of protection of pharmaceutical IPRs (together with other factors), developing countries may also be exposed to higher levels of biomedical FDI, not least in the field of clinical trials.

Keywords

clinical trial foreign direct investment intellectual property rights pharmaceutical developing country 

INTRODUCTION

To what extent does the strengthening of intellectual property (IP) environments in developing countries lead to greater inflows of foreign direct investment (FDI) and technology transfer in these countries?

This is one of the key issues that has been discussed and debated since the TRIPS Agreement entered into effect in 1995.

Arguably, this question is far from being simple and straightforward, not least since the discussion about IPRs and FDI has diversified and deepened during the last 15 years. Ongoing debate focuses on, for instance, the overall relative importance of changes to IP environments on FDI decisions, and on whether increased inflows of FDI and technology transfer outweigh the costs that may be generated due to an increase in protection of proprietary products.

Naturally, the growing focus on the relationship between IPRs and FDI has exposed some gaps in research that could provide empirical answers to these questions.

Yet, there is a growing body of statistical evidence suggesting that a stronger IP environment does contribute to an enhanced level of FDI and technology transfer in developing countries.

For example, an OECD study finds that in developing countries an increase of 1 per cent in the strength of patent rights resulted in 1.7 per cent increase in FDI flows (based on licensing deals), which in turn resulted in the transfer of know-how, that is innovative capabilities. 1 Furthermore, based on observations from 36 developing countries between 1970 and 1995, and correcting for other determinants of innovation, Léger 2 reports that IPRs have a strong positive impact on investment and innovation in developing countries. Robbins 3 also finds that countries that have increased the level of patent protection over time, including developing countries, become larger recipients of FDI and technology transfer in the form of licensing of patents and trade secrets, as compared to other countries.

Among these studies, some focus particularly on the biopharmaceutical field. Most of these tend to include IPRs among the different factors that may influence biomedical FDI. A report by NERA Economic Consulting 4 finds that IPRs (and their enforcement) are among a range of important determinants of the pharmaceutical industry's willingness to invest in a particular location. In particular, poorer IP regimes were found to place limits on conducting certain types or elements of research in a particular country (pp. 18–19). 4 For example, while many companies would be happy to farm out simpler more commoditisable stages of research to those countries, there remained substantial reluctance to do the same with cutting edge research from which key IP rights and industrial knowledge would be derived.

Berndt et al (2007) 5 find that increased patent protection, especially the patentability of biopharmaceutical products, is one important factor driving the increased globalisation of clinical trials sites. Furthermore, in the Country Attractiveness Index for Clinical Trials, 6 which benchmarks different countries’ appeal as offshore locations for clinical trials, IP protection and enforcement constitute two of the index's 13 components.

Nevertheless, one of the main gaps in ongoing research is the lack of data that focuses specifically on the effect of IPRs on FDI taking place in the biopharmaceutical field. In particular, there is very little data that can be used to determine the extent to which the strengthening of pharmaceutical IPRs will lead to increased inflows in FDI focusing on the biomedical field. For instance, although Berndt et al (2007) take into consideration patent protection for medical devices and diagnostics in addition to their measure of a country's IP regime, their approach is still limited as a measure for the entire environment for pharmaceutical IPRs.

As such the purpose of this study is to look specifically at the level of protection of pharmaceutical IPRs in developing countries and on the number of clinical trials (as a proxy of biomedical FDI) taking place in these countries.

Accordingly, this article does the following. The next section defines FDI and develops the use of clinical research as an appropriate, up-to-date proxy of biomedical FDI. The subsequent section discusses the Pharmaceutical IP Index as a unique measure of countries’ pharmaceutical IP regime. The penultimate section provides the empirical analysis of the relationship between the strength of the pharmaceutical IP environment in different countries and the number of clinical trials conducted in those countries. The final section outlines the strengths and limitations of the findings.

FDI IN THE BIOMEDICAL FIELD

Demystifying FDI

Broadly defined, FDI reflects ‘the objective of obtaining a lasting interest by a resident entity in one economy in an entity resident in an economy other than that of the investor’. 7 Moreover, FDI represents the existence of a long-term relationship between the direct investor and the recipient.

A foreign investor (or investors) can be an incorporated or unincorporated public or private enterprise, a government, a group of related individuals, or a group of related incorporated or unincorporated enterprises.

In its most narrow sense (especially for the purpose of statistical analysis and accounting), the term FDI is applied when foreign investors own at least 10 per cent of the voting power in the enterprise in which they have invested. 7 This share may vary according to the type of the investment entity. For example, when opening a new subsidiary or a branch, a multinational corporation may fully own the new entity, while when making an investment in an existing entity its ownership share may be much smaller.

Today, however, most of the literature investigates the field of FDI via a much broader prism, considering it not only from the financial and legal perspective but also from the view of its substantive aspects. For instance, Lippoldt 8 examines pharmaceutical FDI not only using OECD statistics on financial inflows and outflows in different countries, but also the level of technology transfer that occurs through parent firm and affiliate interaction or local partnerships.

Thus, it is important to identify a proxy for biomedical FDI that captures its practical effect in developing countries.

Measuring FDI in the biomedical field

Biopharmaceutical companies can operate in a given country through a number of different channels. In general, there are three different forms of FDI that are typically undertaken in the biomedical field. First, the bulk of biomedical FDI is likely to take place in research, both basic and clinical R&D. Second, companies are also likely to make significant foreign investments in manufacturing operations, including bulk production, formulation, tableting and packaging. Finally, companies may undertake a range of commercial operations, including setting up an entity, sales and marketing, licensing and distribution, arrangements for regulatory approval, development of health policy and support for medical and community health education.

Clinical trials as a proxy of biomedical FDI

Among the different types or channels of biopharmaceutical FDI, it is possible to argue that clinical research brings a significant added value, taking into consideration both the investing company and the local economy.

The supply side: The value of clinical research for investors

Biopharmaceutical R&D is in an era in which clinical trials are increasingly important. The clinical research phase now represents about 65 per cent of the total cost of the R&D process. 9 At the same time, conducting clinical trials has become more and more complex, and requires large numbers of participants. For instance, while phase 1 trials generally entail 20 to 100 volunteers and phase 2 between 100 and 500, today phase 3 trials can require anywhere between 1000 and 5000 volunteers. 10 Given that clinical trials are becoming so important and costly, it is now almost impossible to conduct them in a single country.

Furthermore, since global demand for biopharmaceutical products is constantly growing, it is also imperative to gather data that matches the locations and populations in which a product will be marketed. Indeed, from an investment perspective, biomedical companies are seeking sites in which they can conduct clinical trials both in a way that would bring them value, as well as provide the most effective means of collecting data.

Therefore, companies consider a range of factors when deciding to conduct clinical trials in a given country. These factors include: the characteristics of the population related to the specific product to be tested; the availability and willingness of the population to participate throughout the duration of the trial; the infrastructure of local hospitals and research centres; the ability of physicians and supporting medical staff to carry out clinical trials and work with international organisations; the ease of the regulatory system including approval of clinical trials (including approval by the relevant Helsinki committees); the stability of the legal system (including the protection of IP); and the costs of performing clinical trials. 11

The demand side: The value of clinical research for local economies

For both developed and developing countries, hosting clinical trials can deliver major health, economic and social benefits, including the following.

First, specific patients are able to access new medicines, some of which may literally revolutionise existing treatments to local diseases. The impact of clinical research is not only that the drug is more likely to enter the local market by virtue of the clinical trial being conducted there. What is more, patients have early access to advanced treatments, even if it is for a temporary period. 12

Second, treating physicians are able to participate in cutting edge research, as well as become members of a multi-centre research network. Such experience helps build prestige, and expands their ability to publish their research and become key opinion leaders in their fields. 13

Third, research and health-care institutions are enabled financially to provide clinical trials aimed at the local population, which, not least, becomes savings to a portion of the public health-care cost, especially for new, expensive drugs. 14 Also, clinical trials often involve funding for local research and clinical services, which may lead to new or improved hospitals and clinics, and access to new technologies.13, 15 In addition, by conducting clinical trials in cooperation with key pharmaceutical companies or international organisations, institutions gain prestige (p. 46). 14

Fourth, conducting clinical research in a foreign country provides additional work for clinical research organisations (CROs) and site management organisations (SMOs). In many cases, contract research operations can become an industry in itself as demand increases for local offices to organise the clinical sites (that is, hospitals) and ensure that clinical trials are managed according to international standards (p. 19). 14 Indeed, the growth of the CRO sector has generally occurred in markets where pharmaceutical companies are strategically present to a lesser extent or operation of the trial is more complex (p. 18). 14 Hence, CROs and SMOs represent potential for employment growth.

Fifth, conducting clinical trials has important benefits for the state. It raises the level of treatment accessible by the general population. It also raises income for the state – a PricewaterhouseCooper study found that more than one-fourth of revenue earned on clinical trials by sponsors in Poland ends up as a directly paid tax contribution to the state budget (p. 46). 14 Finally, hosting clinical trials helps raise the standards of clinical research in the country. Local researchers and clinicians are exposed to, and gain experience in, ‘good clinical practice’, and new techniques and treatment strategies. 15

The benefits for host countries, particularly developing countries, of collaborating in clinical research are visible in the examples of Singapore and India.

Singapore is a striking example of a country that in the last decade has built up an active biomedical science system from almost no base before 2000. 16 As a result of research collaboration and reciprocal government investment, Singapore has transformed into a key player in biomedical R&D, especially in translational and clinical research. It has boosted its science base, attracting national and foreign scientists to its new research institutes and ‘bioclusters’, built state-of-the-art infrastructure and developed key partnerships with many established biopharmaceutical companies. From 2000 to 2007, the manufacturing output of the biomedical industry quadrupled from $6.3 billion to $24.4 billion, making it one of the fastest growing sectors in Singapore's economy. 17 The number of workers employed in this sector has also increased from 5880 to 11 887. The growth of the biomedical industry has had important spillovers into the health care and health tourism industries, which had a value added of S$2.45 billion in 2008 (1 per cent of GDP).

Furthermore, data obtained from the national statistical surveys of the Singaporean Agency for Science, Technology and Research (A*STAR) suggest that biomedical FDI has increased by more than 10-fold in the last decade – from S$28 million in 2000 to S$296 in 2008. 18 FDI in clinical research and development has also increased, from S$7.32 million to S$133.67 million in 2009. 18

India has also seen significant growth, particularly in the generic, and increasingly in the research-based, biopharmaceutical industry. India is one of the leading manufacturers of medicines aimed at the developing world, in particular generics. However, the clinical research and trials segment has grown significantly over the past few years with projected revenues of $1–2 billion in 2010, including research by Indian firms. 19 India offers a diverse, ‘drug-naïve’ population, and a pool of facilities and trained research personnel at a relatively low price. 20 Research labs and Contract Research Organisations (CROs) now provide sophisticated tests and diagnostics, in addition to bioequivalence studies. Leading health-care providers are conducting clinical trials in cooperation with overseas authorities. For example, in 2008 Indian companies were doing some $100 million worth of clinical trials work for the EU (p. 22). 19

Furthermore, research collaboration has led to exchange of health-care workers, including doctors, nurses and technicians, as well the professionalisation of local CROs, with developed countries. Such movement will no doubt help stimulate the flow of new knowledge, technologies and standards into India. For instance, coinciding with its growth as a clinical research base, India has adopted guidelines on ‘good clinical practice’, including patient consent, in line with global norms (p. 193). 20

That being said, and as discussed later in this article, despite the tremendous growth in the capacity and willingness to conduct clinical trials in India, it would seem that India's potential is still significantly untapped, given the fact that the volume of clinical trials conducted in India is still quite limited relative to the size of its population.

Overall, though, given that clinical research provides such added value, for both the investing company and the local economy, we can assert that it is a strong proxy for biomedical FDI.

Clinical trials and IPRs

What is the relationship between IPRs and clinical trials? One can say that there is not necessarily a direct, causal relationship. Rather, as mentioned earlier, the IP environment in a country is part of a set of factors that influence the decision to conduct FDI in that country, not least biomedical research. Therefore, it is more of an enabler of biomedical FDI, including clinical trials.

Furthermore, investors are more likely to consider the impact of the IP environment on the broader investment strategy, including marketing of the final product or establishing of a research facility or subsidiary. For example, if a country has a weak IP environment (that is, the potential for a new product to be copied is high) companies are less likely to launch it there, and therefore, the incentive for establishing a subsidiary and conducting advanced phase clinical trials in the country is greatly decreased. Hence, the attractiveness of one area of biomedical R&D – in terms of the IP environment along with other factors – can impact on the draw to invest in other areas. Indeed, if at one point in time, a country is less attractive for, say, a joint venture, then it is also likely to deter investment in clinical trials or other facets of biomedical R&D in the future.

Therefore, it is not that IPRs and the IP environment have a specific effect on a single decision to conduct clinical trials in a country. Rather, it can be said that IP is one signal of the volume of biomedical investment (as measured by clinical trials) that a country is likely to experience.

THE PHARMACEUTICAL IP INDEX AS A MEASURE OF STRENGTH OF THE PHARMACEUTICAL IP ENVIRONMENT

Although several indices exist to measure the strength of a country's general IP environment, such as those constructed by Rapp and Rozek 21 and Park and Ginarte (1997) 22 , none focus on the specific regime for pharmaceuticals except the Pharmaceutical IP Index. The Pharmaceutical IP Index is a tool aimed at measuring the pharmaceutical IP environment in a given country in a systematic and coherent manner. The index was developed in 2003 by this author and was first published in 2006, in the Journal of World Intellectual Property, Volume 9, Number 4 (July 2006). 23 Subsequently, the Pharmaceutical IP Index is now an accepted tool for measuring for pharmaceutical IP environments, having been published and cited in numerous peer review journals, articles, presentations and reports by international organisations such as WIPO and the OECD.

The Pharmaceutical IP Index measures different expressions of IP relevant to the biomedical field, including not only patent protection but also other factors such as data exclusivity, trademark protection and special regimes for orphan and paediatric medicines. Concerning these different forms of IP, the index measures five different aspects of the level of protection granted: the term of exclusivity, the scope of exclusivity, the strength of exclusivity, barriers to full IP exploitation and enforcement. Each aspect is further divided into sub-categories, with 22 indicators in total. Each indicator is weighted according to its relative importance in the pharmaceutical IP regime, based on which an overall score of between 1 and 5 is calculated. Table 1 shows the different categories and sub-categories of the index, and the relative weight given to each. However, this study will simply use the overall score for the countries examined, as previous studies have done.
Table 1

Structure and weights of the pharmaceutical IP index

Category

Sub-category

Weight (%)

Total

Term of exclusivity

Basic term of patent protection

40%

 
 

Patent extension period

20%

 
 

Data exclusivity for new drugs (NCEs)

20%

 
 

Orphan drugs exclusivity

10%

 
 

Data exclusivity for new indications

5%

 
 

Paediatric drug exclusivity

5%

 
  

Total

100%

Scope of exclusivity

Coverage of pharmaceutical patents (products and processes)

40%

 
 

Coverage of biotechnology patents

20%

 
 

Non-disclosure of test data

20%

 
 

Non-reliance on test data

20%

 
  

Total

100%

Strength of exclusivity

Restrictions on the use of compulsory licensing

40%

 
 

Prohibiting parallel imports

40%

 
 

Prohibiting commercial testing during the patent term (‘Bolar’ provisions)

20%

 
  

Total

100%

Barriers to full IP exploitation

Competitive pricing – free pricing without regulatory restrictions on price controls or reference pricing:

  
 

 • Absence of requirement of price negotiations as a pre-condition of product approval or reimbursement

30%

 
 

 • Absence of reference pricing system

20%

 
 

 • Absence of controls on profits

10%

 
 

Post-grant opposition (as opposed to pre-grant opposition)

20%

 
 

Direct to consumer advertising of prescription drugs – (DTCA)

10%

 
 

No restrictions on the use of brands in packaging (trademarks)

10%

 
  

Total

100%

Enforcement

Effective civil remedies

40%

 
 

Effective criminal procedures

40%

 
 

Effective policing actions against piracy and counterfeiting

20%

 
  

Total

100%

AN EMPIRICAL ANALYSIS OF THE LINK BETWEEN PHARMACEUTICAL IPRs AND CLINICAL RESEARCH

Data and methodology

As discussed above, this study uses the overall score of the Pharmaceutical IP Index to measure the strength of the pharmaceutical IP environment in a given country.

The measure of biomedical FDI via clinical trials is based on the ClinicalTrial.gov database, which contains all registered, FDA-certified clinical trials taking place in the world by different pharmaceutical companies and other entities. Previous studies, such as Berndt et al 5 and the Country Attractiveness Index for Clinical Trials 6 have also used ClinicalTrials.gov to measure the number of clinical trials conducted in a given country.

The study focuses on the general number of clinical trials conducted in different countries; it does not consider, for instance, the monetary value, the nature (for example, pharmaceutical, medical device, and so on), the target population or the phase of the trial.

Nonetheless, this measure is sufficient for the statistical examination focused on in this study – whether or not there is a correlation between the volume of clinical trials taking place in a given country and the strength of the pharmaceutical environment in that country.

In order to standardise the volume of clinical trials, the number of clinical trials per country is divided by the country population in millions.

The study examines 12 countries, including both developed and developing countries.

Results

Table 2 provides the Pharmaceutical IP Index score for each country and the number of clinical trials per million people per country.
Table 2

Data

Country

Population in millions a

CTs per region (February 2011) b

CTs per region per million population

Pharmaceutical IP Score c

United States

309.6

52 652

170.06

4.67

Singapore

5.1

772

151.37

4.4

United Kingdom

62.2

5286

84.98

4.37

Australia

22.4

2806

125.27

3.3

New Zealand

4.4

676

153.64

3.3

Chile

17.1

598

34.97

3

China

1338.1

2029

1.52

2.62

Brazil

193.3

2139

11.07

2

Philippines

94

448

4.77

2

South Africa

49.9

1213

24.31

2

India

1188.8

1539

1.29

1.8

Thailand

68.1

836

12.28

1.2

Sources: aPopulation Reference Bureau, World Population Data Sheet (mid-2010).

bClinicalTrials.gov website (accessed 28 February 2011).

cPugatch (2010), Pharmaceutical IP Index, updated results to be published.

The correlation between the Index score and the standardised volume of clinical trials for the 12 countries is found to be 0.84. Figure 1 depicts the correlation.
Figure 1

Strength of pharmaceutical IPRs vis-à-vis clinical trial activity.

In addition, correlations were calculated for the Index score and industry-led clinical trials only and for the absolute (non-standardised) volumes of clinical trials. Table 3 gives the four correlation calculations.
Table 3

Correlations of clinical trials with pharmaceutical IP index

Data – Volume of clinical trials

Correlation with IP Index

IP Index-CTs (Location)

0.84

IP Index-CTs (Location+Industry-led)

0.76

IP Index-CTs (Location−Absolute numbers)

0.52

IP Index-CTs (Location+lndustry-led−Absolute numbers)

0.54

DISCUSSION

It is important to note that statistical work on empirical data based on a small sample naturally has its limitations. The results are, of course, heavily influenced by various deviations. In this case, the data are limited to 12 countries (including China and India which are strongly affected by the standardisation denominator) and this certainly impacts on the correlation.

Yet, having said this, the results are quite strong. In particular, the correlation between the standardised volume of clinical trials per region and the IP Index score is 0.84. Hence, overall we can predict that a country with a strong pharmaceutical IP environment will have a greater inflow of biomedical FDI. Naturally, IPRs are not the only factor in biomedical entities’ decision to invest in another country, and the correlation does not mean that IP protection will directly affect the level of biomedical FDI. Nonetheless, it is an important empirical indication that a higher level of IP protection could be reflected in a great level of clinical trial activity in a given country.

The few major outliers, such as China, demonstrate, on the one hand, that population or market size does influence the relative level of investment. In the case of China, if we did not standardise the calculation (that is, if we did not take the population into consideration), we would see a larger volume of clinical trials and a higher correlation overall. Hence, China's population of 1.3 billion is huge, and clinical trial activity is still catching up with the number of people there. Yet it is important to note that in general, since by nature clinical trials deal with people, in a way they should be linked to population. To put it another way, on the whole when it comes to clinical trials, the larger the population, the larger the market should be for trial participants (if other factors are in place).

On the other hand, if China is compared with India, a country with a similar population size relative to the rest of the world, we can see that both in standardised and absolute terms, China's volume of clinical trials (1.52 and 2029, respectively) is higher than India's (1.29 and 1539, respectively). This correlates with China's IP score (2.62) being higher than India's (1.8).

That being said, despite the market size of China, the number of clinical trials is still relatively small. This would seem to run contrary to the argument that investment should be linked to market size. It is clear that other factors, in addition to the strength of the pharmaceutical IP environment, are at play in determining incentives for biomedical investments in China.

We can say the same for New Zealand. Despite its small market size, it is still a fairly attractive site for clinical trials.

In addition, the low level of clinical trial activity in the United States in relation to its Pharmaceutical IP Index score can partly be explained by the need of many American companies to outsource clinical trials, because of the reasons mentioned above (that is, the need to conduct clinical trials in multiple centres).

However, generally, we need to look at the data set as a whole. Overall, the data suggests that the strength of national pharmaceutical IP environments provide a good estimate of the level of clinical trials taking place in these countries. Accordingly, countries with a more robust level of pharmaceutical IP protection tend to enjoy a greater level of clinical trial activity by multinational research-based companies.

Naturally, it would be important to examine the relationship between IPRs and clinical trials over time, that is not only to provide a ‘snapshot’ of the relationship at a given point of time, but also to repeat this exercise over the time axis. This would allow us to examine whether there has been a shift in the strength of national pharmaceutical IP environments of different countries vis-à-vis the volume of clinical trials that are being conducted in these countries. For example, data from Singapore suggests that with the increase in the pharmaceutical IP score (from 3.3 in 1998 to 4.4 in 2004, following the free trade agreement between Singapore and the United States) there has also been a significant increase in the volume and value of FDI in biomedical research, including in clinical trials (see Figure 2).
Figure 2

FDI in BioMedical R&D in Singapore (calculations based on A*STAR R&D Survey Statistics 2000–2008).

Yet overall, in the ongoing quest to accumulate more evidence-based data concerning the relationship between IPRs and FDI in the biomedical sector, the above research provides yet another validation that such a relationship does exist. In other words, by choosing to improve their level of protection of pharmaceutical IPRs (together with other factors), developing countries may also be exposed to higher levels of biomedical FDI, not least in the field of clinical trials.

References and Notes

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Copyright information

© Palgrave Macmillan, a division of Macmillan Publishers Ltd 2011

Authors and Affiliations

  1. 1.Division of Health Systems AdministrationSchool of Public Health, Univeristy of HaifaTel AvivIsrael

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