Lifelong Learning and the Knowledge Economy (RWL 2015)

The Challenge of Delivering CPD Training for the Pharmaceutical Sector in Ireland, Singapore and Puerto Rico with Differing Policies for a Knowledge-Based Economy

By Gerard Creaner
Publication Date: November 2015

This paper was presented at the 9th Research Work & Learning Conference (RWL) 2015

Abstract

This paper offers an analysis of the author’s ten-year experience as a private training provider delivering technical continuing professional development (CPD) training for the pharmaceutical manufacturing sector in Ireland since 2005, Singapore since 2008 and Puerto Rico since 2014. 

This training was delivered both to employees within the pharmaceutical manufacturing companies and to experienced workers from other sectors who wished to make a career change into this highly regulated sector. Negotiation, development and delivery of training in each of the three locations highlighted the significance of how local economic development policies for the sector are shaped both by local understandings of a knowledge-based economy and by the requirements of the international drug regulatory authorities. 

The research is essentially a comparison of three cases using Bereday’s four stages of description, interpretation, juxtaposition and comparison as both methodology and structure. Data for the paper were drawn from relevant economic policy and employment literature for each of the three sites, from relevant pharmaceutical sector regulations, and from original documentation in relation to development and delivery of the CPD programmes concerned. 

The findings in this paper give an insight into dynamics of CPD provision as a function of fluctuations in national economic conditions/wellbeing of a nation. It questions the true relevance of broad- based lifelong learning initiatives in creating a sustainable knowledge-based economy for a hi-tech industry, if such initiatives are abandoned at the first sign of economic difficulty. 

The paper makes observations about the long-term impact of tensions for the development of a knowledge-based economy for the provision of learning in the pharmaceutical manufacturing sector and discusses specific recommendations based on my insights. These have been gained during this ten year analysis, primarily from Ireland and Singapore: in Puerto Rico only the Government negotiations and approval process has been completed to date. 

Insights presented in this paper have come from training and educating 1500 workers, interfacing and negotiating with numerous Government agencies, and meeting with fifty multinational pharmaceutical companies. 

Insights include the following:

  • It appears that whilst a knowledge-based economy requires the lifelong learning of its citizens in order to succeed, many technical workers are reluctant to invest
  • their time and effort into technical learning programs after employment has been
  • secured.
  •  Despite many pharmaceutical companies hiring large numbers of graduates from
  • my CPD programs since 2011, they have not looked for their existing operators
  • and technicians to undertake similar CPD programs.
  •  Whilst current theory and Government strategies supports the building of a
  • knowledge-based economy through the lifelong learning of its workers, neither the employers nor the workers appear to want to invest their time and effort once the resource is hired or the job is secured.
  •  I question if a nation can develop a knowledge-based economy without the emotional support of its citizens and employers for lifelong learning.
  •  I question whether the case for legislation of lifelong learning for both companies and the workforce in certain industry sectors which could benefit a nation and its citizens should be considered.

Introduction

Periods of economic turbulence are useful instances to identify both the explicit and implicit socio-economic models at play in a given country. Long term aspirational projects which require funding during growth periods get challenged by short term critical needs during more difficult recessionary times, particularly with regard to investment in education and training. The ten year time-frame of this analysis (2005- 2015) has been a very interesting time of great economic turbulence across the world. In 2005 the East was still recovering from the 1997 Asian Financial Crisis and the West was still riding high in the aftermath of the dotcom-fuelled boom. Ireland was at the heights of the Celtic Tiger and the US Federal Reserve Chairman Alan Greenspan was projecting continued growth in the US economy (Greenspan, 2005). It was during this recovery and expansionary stage that the three cases analysed in this paper had their genesis.

Only three years later the world was a very different place with Global Recession in the West and the associated huge job losses and contraction of economies. This recession initially impacted on the markets in Asia but they recovered quicker and more strongly than the West, led by the BRIC (Brazil, Russia, India, China) economies and China in particular (Singapore ESC, 2010) The global crisis reinforced the shift of the economic markets to Asia.

The impact of this global economic turbulence is viewed through my lens of a specialist private training provider delivering education and training solutions for the pharmaceutical manufacturing sector. Government policies in place at the start of the analysis period (2005-2008) reflected long-term aspirations that countries were happy to budget for during boom times which were expected to continue. 

During the middle period (2008-2011), which could be defined as ‘bust times’ on a global scale, the sustainability of the ‘boom time’ projects were challenged and the different Governments made different decisions about continuing their planned investments in a knowledge-based economy during these more difficult times. 

The final time frame (2011-2015) can be referred to as moving into a period of ‘cautious growth’ during the recovery period of the world economies after the 2008 global downturn. The particular ten year timeframe of this analysis has offered a great opportunity to witness how the implementation of Government policies in Ireland, Singapore and Puerto Rico changed due to the social and political challenges from significant fluctuations in their national economy during the three different periods of boom, bust and cautious recovery.

Research Approach and Structure of Paper

This paper is broadly practitioner research using three cases as illustrative of real world phenomena. The stance is reflexive and critical, acknowledging that the knowledge presented cannot be easily separated from the knower. As author I am in the space straddling insider-actor mode and outsider-observer mode acknowledging my involvement in both modes. The reflexivity involved is essentially introspective rather than systematic or methodological. Essentially the work falls within the genre of practitioner research on past and current activities without those activities being deliberately planned as cyclical action research. Selection of data and their interpretation within layers of analysis are as deemed meaningful and relevant by me as author (Robson, 2011).

The methodology for comparison of the three cases draws heavily on Bereday’s model of comparative styles and their predispositions (Bereday, 1966, 1967). In Bereday’s model ‘everyday’ comparability is distinguished from socially-scientific or laboratory methods. The ‘everyday’ comparability approach fits with individualistic practitioner research in that it favours establishing relations between observable facts, noting similarities and graded differences, drawing out universal observations and criteria, and ranking them in terms of similarities and differences. In everyday comparability the view is subjectively from within, and deliberately without perspectives detachment. It focuses on group interests, social tensions, impact factors and collective beliefs, patterns and behaviours as experienced by the researcher. While Bereday’s model is relatively aged it nonetheless is appropriate in this paper as a tool to structure iterations of analysis which stress the value of balanced enquiry within broad contexts. Bereday recommends illustrative comparison where data are too-imprecise for fully balanced comparison, as in the case described in this paper.

In terms of analytical steps this paper uses Bereday’s four stages as illustrated by Jones (1971 page 88) as follows:

  • Stage I: Description of each case using a common approach to present facts
  • Stage II: Interpretation of the facts in each case using knowledge other than the author’s
  • Stage III: Juxtaposition for preliminary comparison using a set of relevant criteria 
  • Stage IV: Simultaneous comparison emergence of conclusions and hypotheses.

The structure of the paper follows from the methodology above. In the first part the context of the Pharmaceutical manufacturing sector is outlined and the reasons for the development of manufacturing hubs in the three countries.

In Sections 3 and 4 the cases of Ireland, Singapore and Puerto Rico are described in terms of the local stage of industrial development, government policies for a knowledge based economy, the contribution of lifelong learning of the workforce and the government support for the pharmaceutical industry.

The pre and post 2008 Global Economic downturn in each of the countries is examined through the lens of initiatives for CPD training programs for their workforce, driven by the different social and political consequences for each country. Sections 5 & 6 sets out the three cases in juxtaposition in tabular form as suggested by Bereday and identifies areas of convergence and divergence between the countries.

The perspective in this paper is my own as the private provider of CPD training in the three case studies, mindful of the particular risks of insider research (Rooney, 2005). To acknowledge this insider status ‘I’ and ‘we’ are used throughout.

The Pharmaceutical Manufacturing Context

The Pharmaceutical sector involves the manufacture of medicines and medical devices. These products, and the companies which manufacture them, are also referred to as Life Sciences, MedTech and BioMed in different parts of the world, as noted in the list of references for this paper. However for the purposes of clarity they will all be referred to by the single term Pharmaceutical.

Pharmaceutical companies are in the business of manufacturing safe medicines for the public at an affordable cost which does not entail excessive regulatory oversight (FDA Mar 2004). This essentially defines how the sector is regulated by the Food and Drug Administration (FDA) in the US and by other international regulatory agencies in different parts of the world, including the EMA (European Medicines Agency) in Europe. While each individual agency will have specific nuances regarding how they apply their regulations, all of them regulate the companies in their jurisdiction within the spirit of this definition. For the purposes of this paper all regulatory agencies will be referred to by the single term FDA.

To elaborate the above definition of the pharmaceutical manufacturing sector so as to better understand the basis of the CPD programmes addressed in this paper, firstly it is useful to consider what constitutes a ‘safe medicine’ and how it is determined to be safe to take. In order to confirm that a medicine is safe to use it has to be tested under controlled conditions. But if one tablet, or the contents of one vial, is tested, how does one know that the injection from another vial will do no harm and will help to effect a cure?

It is only practicably possible to test a representative portion of the medicines that are manufactured to determine that they are safe to use and so the FDA has defined a series of Quality Systems and Good Manufacturing Practices (GMPs) to be used to also check for manufacturing compliance. If an FDA audit deems that the manufacturing has been in compliance with the GMPs and the portion of medicines tested are determined to be safe, then all of the medicines that have been manufactured are deemed to be safe and can be sold to the public.

A very extensive and onerous set of GMPs will increase the cost of manufacturing medicines in order to be in compliance with the regulations and it will also increase the efforts and time spent by the FDA to audit for compliance. High costs of compliance will result in more costly medicines for the public and fewer people being able to afford them. Hence the mandate of the FDA is to ensure the public has access to safe medicines at an affordable price not entailing excessive regulatory oversight. This in essence forms the basis of the Mission Statement for all Pharmaceutical manufacturing companies and it is the basis of the CPD programmes delivered by this training provider in three global locations, i.e. Europe (Ireland), Asia (Singapore) and America (Puerto Rico).

These three locations were chosen to deliver these CPD programmes as they are all significant pharmaceutical manufacturing hubs in this highly regulated industry, often referred to as Centres of Excellence in the promotional literature from their Government agencies (PharmaChemical Ireland, 2010).

Governments compete to enter the Pharmaceutical manufacturing supply chain as it is a very stable and secure hi-tech. manufacturing sector. It generates long-term good paying jobs. Its workers have salaries in the top quartile and it supports very significant capital investments to build these manufacturing facilities. In Ireland the replacement capital asset value of its current pharmaceutical manufacturing facilities is $50 Billion and new investments underway in 2015 are valued at a further $3 Billion (IDA Ireland, 2005). Significant capital investment to a value of $60 Billion has been made in Puerto Rico since the 1960s when the first pharmaceutical manufacturing facilities were established on the island (Jones, 2006). In Singapore, significant investment only commenced in the late 1990s following a Government decision to focus on establishing pharmaceuticals as the fourth pillar of the Singapore economy. Their BioMedical Science (BMS) sector already employs 6,000-workers in pharmaceutical manufacturing and is their largest manufacturing sector generating 5% of GDP. (Singapore EDB, 2013)

chart replacement capital asset value of manufacturing sites plants

Knowledge Economy and Lifelong Learning in Three Locations

The three cases analysed which are central to this paper are located in Ireland, Singapore and Puerto Rico, all small island states with a growing dependence on knowledge-based manufacturing and services economies. All three have identified the pharmaceutical sector for economic and labour market growth and continue to invest significantly in relevant education and training and in labour market measures to support the continued growth of the sector (The Stationary Office, 2006; Commonwealth of Puerto Rico, 2014; Singapore ESC, 2010). All three use the English language in addition to local languages, have well developed education and training systems, have relatively young populations, are politically stable and strategically located on efficient and viable air and sea transport routes to potential markets.

Pharmaceutical companies have very high levels of human intervention in their manufacturing process at an operator/technician level. This workforce has predominantly a High School or non-degree 3rd level academic qualification and this frames the workforce development structures necessary for achieving Centre of Excellence status for manufacturing safe medicines. The nature of the manufacturing process requires decisions and inputs from the operators/technicians in order to move onto the next step in the process. Hence the overall process, whilst technologically complex, cannot be defined as ‘automated’ where human intervention has been eliminated, unlike other hi-tech industries. This human intervention requires that the workers be familiar with, and apply, the GMPs defined and audited by the FDA to ensure manufacturing compliance for the approval and release of safe medicines to the public.

Consistency in human interactions is difficult to achieve. The FDA records clearly shows that significant non-compliance still occurs in both large and small pharmaceutical manufacturing companies in the West, despite decades of manufacturing experience and regular FDA audits (Deloitte, 2013).

This business risk to serious quality problems from manufacturing errors has contributed to the establishment of pharmaceutical manufacturing hubs both within the US and across the world. These hubs are the locations where the industry has greatest confidence in the rigour of the manufacturing process and the ability of the workforce to manufacture in compliance with FDA regulations. A strong manufacturing quality track record is a key factor as to why Ireland, Puerto Rico and Singapore have differentiated themselves from other countries in this niche hi-tech highly regulated manufacturing environment. It is a key element of their Governments’ strategies for developing a knowledge-based economy for the benefit of their citizens and it is the basis of the training and education programmes developed by this specialist training provider.

chart pharmaceutical exports for ireland singapore puerto rico

The Irish Case

In 2005 the Irish economy was experiencing a phase of sudden economic growth. Government thinking about a knowledge-based economy was encapsulated in their seven year Strategy for Science Technology and Innovation 2006-2013. (The Stationary Office, 2006) This document contained references to improving maths and science in junior schools, doubling PhD numbers, commercialising university research and investing in mechanisms to translate knowledge into jobs and growth. Funding was made available to the pharmaceutical manufacturing sector to provide up-skilling of existing staff and re-skilling of workers looking to transition from other less dynamic sectors into this hi-tech industry.

In 2005 I formed an industry-academia partnership with the Dublin Institute of Technology (DIT) which had a lengthy track record in the science sector. A Bachelor of Science degree programme for experienced workers who wanted to make a career transition into the pharmaceutical manufacturing sector in operator/technician roles was developed using a modular, work-based learning model. This twelve module programme consisted of six industry-specific modules on the manufacture of safe medicines delivered by my private company and six modules focussed on the underpinning science associated with pharmaceuticals provided by the DIT partner and awarding body.

This industry-academia model was an innovative approach to developing a pool of talent to both satisfy a pharmaceutical company’s employment demands and also allow the Government to continue to attract more Foreign Direct Investment (FDI) for new manufacturing facilities into Ireland. Companies could select the numbers and sequence of modules to suit their immediate needs, seamlessly combining self- financing and state-funded learners. However, with the 2008 Global economic downturn, the Irish Government withdrew funding support and the training model diminished.

The economic downturn in Ireland resulted in 200,000 workers losing their jobs during 2008-2010, increasing unemployment levels to 15% with the associated loss of pay related tax revenues to the Government and the huge increase in social welfare unemployment payments to these retrenched workers. The social and political problems from Government cuts to services to bring financial balance back to the economy were huge. Funding for ‘aspirational’ projects from the ‘boom’ times without a quantifiable outcome in the short term was stopped, including our program.

chart unemployment rate-for-singapore ireland puerto rico

Without Government funding workers generally did not view self-funding for re- skilling to a new industry sector as a good personal investment. The pharmaceutical companies who had benefited from the Governments initiatives during the ‘boom’ years to up-skill their workforce also did not continue these programs when the Government funding ended, preferring to train their employees with short in-house programs specific to their needs.

This questions the true relevance of such broad-based lifelong learning initiatives in creating a sustainable knowledge-based economy for a hi-tech industry, if they can be abandoned at the first sign of economic difficulty.

In Ireland, the pharmaceutical sector remained resilient to this economic downturn and continued to expand. In 2009 the Government reacted to the social and political challenges of high unemployment and shifted its focus from a co-funded general training approach to a fully funded sectoral training initiative to reengage unemployed workers into employment. Pharmaceuticals was identified as one of six sectors appropriate to absorb significant numbers of recently unemployed, skilled workers through a series of Labour Market Activation (LMA) schemes, later known under the name of Springboard (The Stationary Office, 2014).

This Government re-skilling initiative has continued through the ‘bust’ times and into the cautious recovery period to the present day. It is focussed on transitioning retrenched workers back into employment in specific industries through academically accredited industry relevant programs. Full funding for the trainees is provided and securing employment rather than an academic qualification from the program is the priority of the Springboard initiative, even though it is administered through the Higher Education Authority (HEA) and not the Department of Labour.

It is a very different model to the one that was used in the ‘boom’ times. It is focussed on much more immediate and measurable outcomes, as most programs have to be completed on a part-time basis and within one year. Programs are tendered for annually on a competitive basis (my CPD program has been funded for five consecutive years under this initiative) and a key criteria for selection is the success of past trainees in securing employment in these identified hi-tech industries which contribute to the growth of the economy.

Between 2011-2015 in excess of 1,000-workers attended my online academically accredited CPD programs under the Springboard initiative and 75% of these workers have successfully secured employment. This re-skilling model can be classified as “Train and Place” where a pool of qualified workers are trained with industry relevant knowledge, skills and qualifications and then companies draw from that pool to place them in their companies to meet a resource requirements.

The take up of the CPD program in Ireland for those with jobs looking to make a career change into pharmaceuticals only comprises of 4% of our trainees. Those who are in employment have to self-fund on my programs, as Government funding is only available for the unemployed.
Even in the case of reskilled workers who have successfully gone through my CPD program under Springboard only 2% of these go onto further CPD programs (or complete the full BSc degree) after securing employment. It appears that whilst a knowledge-based economy requires lifelong learning initiatives for its citizens in order to succeed, many technical workers do not want to invest their time and effort into technical learning programs after employment is secured. These workers appear to be willing to complete technical programmes as a means to an end (i.e. get a job, secure a promotion, earn more money) but not to become a more skilled/proficient worker (master craftsman).

I have also observed that whilst pharmaceutical companies have hired large numbers of Springboard graduates from my CPD program since 2011 and their CPD qualification was a key part of the hiring decision, these companies do not appear to have incentivized these new hires to complete more of my CPDs. Likewise even with these large numbers of new employees successfully absorbed into the industry, the companies have looked for their existing operators and technicians without these qualifications to undergo similar technical development CPD programs.

It appears that whilst the Government’s Springboard initiative supports the idea of building a knowledge based economy through the lifelong learning of its citizens, neither the employers nor the workers appear to want to invest the time and effort in it through more CPD programs once the resource is hired or the job is secured. I question if a nation can develop a knowledge-based economy without the emotional support of its citizens and employers for lifelong learning. Therefore is lifelong learning a real self-sustaining entity or does it is require to be continually hooked up to a Government life-support system to survive?

The economic context, narrative and elements of the Irish case study are summarised in Table 1.

The Singapore Case

The Singapore Government decided in the late 1990s that pharmaceuticals would become the 4th pillar of the economy, The BioMedical Science sector (BMS) has rapidly grown in Singapore and in 2014 BMS manufacturing output had increased to $6 billion and was employing 6,000 workers (Singapore EDB, 2013).

The success in creating a pharmaceuticals sector has also supported the Government strategy for creating a knowledge-based economy with high paying jobs and significant capital investment.

In 2007 Government was also planning to establish a national competency framework for all industry sectors, the Workforce Skills Qualification (WSQ). Pharmaceuticals were seen as a key sector in this, even though the direct employment numbers at the time were only 3,000 workers (Dept. of Statistics Singapore, 2015). Singapore was also looking for mechanisms to transition workers from their electronics manufacturing sector (which was in decline) into this hi-tech highly regulated industry sector, which was to become the 4th pillar of the economy (Singapore EDB, 2013).

Around that time the Singapore Government became aware of my initiative in Ireland to create a pool of experienced workers from other industry sectors to transition into the pharmaceutical manufacturing sector. I was invited to bring my initiative to Singapore, as they were facing similar problems with workforce shortages in their pharmaceutical manufacturing sector.
The Singapore Government reacted immediately to the economic downturn in 2008 with a significant investment in training and skills upgrading for the workforce to better weather the economic storm. Working adults took advantage of upgrading and retraining programmes so as to remain relevant and employable in the job market under the Skills Programme for Upgrading and Resilience (SPUR) initiative. SPUR leveraged on the extensive CET (Continuing Education & Training) system already in place to scale-up training programmes and help companies and workers during the economic downturn, building stronger manpower capabilities for the recovery. The modules from the DIT BSc programme which had been aligned with the WSQ competency framework were included under the SPUR initiative of 800 courses which workers could avail of for two years from 2008-2010 (Singapore ESC, 2010).

Whilst this was a very innovative response from the Singaporean Government to the 2008 Global Downturn the response of the Irish Government to initially withdraw funding from training initiatives when the downturn happened seems very short sighted in comparison. It is important to also view this decision in the light of the fact that there is no unemployment benefit structure in Singapore, unlike Ireland. Hence in Ireland the Government had a legal requirement to use available budgets to first pay unemployment benefits to workers who were retrenched. In Singapore the social and political consequences of workers being retrenched without any income from unemployment benefits had to be addressed. Hence the equivalent of these ‘unemployment benefits’ were invested in an innovative and practical way to the benefit of its citizens through the SPUR programme and without creating the ‘sense of entitlement’ associated with social welfare programmes in other countries.

During the two years of SPUR, over 250 workers completed my pharmaceutical re- skilling CPD programme and 75% of these workers successfully transitioned into employment both directly with pharmaceutical manufacturing companies or into the network of supporting companies which are part of the overall pharmaceutical industry ecosystem.

Interestingly, by 2010 the Singapore economy had recovered from the Global downturn and it led the first world countries with a return to pre-2008 unemployment levels of less than 3%. When this happened SPUR funding was discontinued and a new training framework SkillsConnect was introduced which was less inclusive than SPUR. A key difference was the change from creating a pool of talent from which industry could select employees (i.e. a “Train and Place” model) to one where re- skilling was only offered to workers who had already secured placement with a company, i.e. using a “Place and Train” model. Enrolment on this program was predominantly for company employees rather than those who wanted to acquire the skills and qualifications to make a career change before they had secured a job in the industry.

This new model would minimize the extent to which the tax-payer should be burdened with creating a pool of resources that industry may never use. It was founded on the belief that industry would hire the most suitable candidates available in the marketplace and it would be more efficient to only train those people.

Between 2011-2013 I observed the negative effect that this change of model had on the development of a knowledge based economy through lifelong learning of the workforce. Without access to a pool of talent the pharmaceutical companies reverted to the previous norm and hired new graduates from the universities for entry level roles into manufacturing – and hence the 250 trainee numbers from 2008-2010 who took these pharmaceutical cross training programmes dropped to twenty-five trainees per year from 2011-2013, even though the Singapore economy had fully recovered from the 2008 Global downturn and had moved beyond the cautious recovery phase and into strong growth like the rest of Asia.

The requirement that only workers who had already been placed in industry could access SPUR training diminished the opportunity for experienced workers to make a career change from ‘sunset industries’, (i.e. often low-tech companies which were in decline but still operating) into the hi-tech pharmaceutical sector that the Government wanted to develop as part of their knowledge based economy strategy. During the “Place and Train” years in Singapore from 2011 to 2013, I took the initiative to transition the classroom materials for my industry specific modules into an online delivery format. This was a co-funded initiative with SPRING Singapore (a Government development agency) and the Centre for Excellence in Learning and Teaching (CELT) at Nanyang Technological University, Singapore (NTU). It was developed originally to give pharmaceutical manufacturing companies more flexibility in being able to release employees for training and hence increase employee numbers going through the WSQ programme, but the companies in Singapore were very slow to engage with this new online delivery format. However the Irish Government embraced it for their Springboard initiative in 2011.

The economic context, narrative and elements of the Singapore case study are summarised in Table 1.

The Puerto Rico Case

Manufacturing of pharmaceuticals began in Puerto Rico in the 1960’s and peaked in 1990, when it manufactured 80% of the major prescription drugs for the U.S. market. At that time it had very favourable tax concessions for US based companies and those were ended 15 years later in 2006 when direct employee numbers in pharmaceutical manufacturing were 28,000 people in Puerto Rico as compared to Ireland (18,000) and Singapore (3,000) (The National Puerto Rican CoC, 2015).

By 2013, employee numbers in Puerto Rico had fallen to 16,000 whilst there had been significant growth in Ireland (25,000) and Singapore (6,000) during the same period. In 2013 the value of pharmaceutical exports from Puerto Rico was $32billion as compared to Ireland ($56billion) and Singapore ($6billion). Once a significantly bigger manufacturing hub than Ireland, Puerto Rico now has significantly diminished to 60% of Ireland’s size but it is still significantly bigger than Singapore.

chart employment in pharmaceutical manufacturing <