, Mohammed Al-Rubaie2, Stuart Walker3 and Sam Salek4
(1)
Regulatory Affairs Consultant Executive Directive, Kuwait Advancement for Conference and Exhibition Management, Kuwait, Kuwait
(2)
Ministry of Health, Directorate General of Pharmaceutical Affairs and Drug Control, Muscat, Oman
(3)
Founder of Centre for Innovation in Regulatory Science, London, UK
(4)
Department of Pharmacy School Life & Medical Sciences, University of Hertfordshire, Hatfield, UK
Introduction
The Gulf Cooperation Council (GCC) was established on May 25, 1981, with the six Arab states (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE). The GCC’s primary role is to formulate standardised regulations in various fields such as economics, finance, trade, customs, tourism, health, legislation and administration, establish scientific research centres, encourage cooperation with the private sector and strengthen ties between the countries. Yemen has joined the GCC only in the healthcare and sports initiatives in 2004, and it was therefore critical to incorporate Yemen in the future strategic planning process being an existing member state that is required to develop and prosper its regulatory system in order to be able to meet the future demand of the GCC regulatory needs.
Throughout the three decades, since the establishment of the GCC, the Gulf states have experienced major challenges in view of the rapid change in the regulatory environment around the world. However, because of their strategic importance, position in the world and rich oil resources, they present significant potential for the growth of the pharmaceutical market. This growth, together with the increase in the price of medicines, has encouraged the GCC authorities to build their individual regulatory systems to deal with the considerable challenges in the pharmaceutical market. However, they realised that the pace of development in their individual markets is currently becoming significant.
The growth of the pharmaceutical market in the Gulf region is 7 % with an expected increase in pharmaceutical sales to US$ 10.8 billion in 2020 from US$ 5.6 billion in 2010 (ALPEN Capital 2010). The six states decided to formulate standardised regulations through their joint efforts to control the access of medicines into the Gulf region. In 1998, the GCC Drug Registration System (GCC-DR) was established as a result of the GCC vision three decades ago. At the same time, the six GCC governments took steps to harmonise their regulatory procedures and a set of guidelines and policies were produced.
Several challenges faced the GCC health authorities to successfully operate the new GCC-DR system. Therefore, they have encountered the need for regulatory reforms during the last 10 years, in order to improve their individual systems and to unify their procedures to achieve improved patients’ access to high-quality medicines throughout the region. These two factors placed the GCC states in a position where establishing a strategic plan is considered critical for them to achieve their goals.
The seven members of the Gulf Cooperation Council (GCC) decided to formulate similar regulations through their joint efforts to improve patients’ access to medicines in the Gulf region. The nature of the individual authorities makes the design of a harmonisation strategy rather difficult before a full evaluation of each of the six authorities (plus Yemen) has been carried out. Therefore, a systematic planning process which involves identifying the status of the GCC authorities, their vision and mission statements, operating values, goals and objectives, priorities and monitoring their strategies and action plans are critical for the successful harmonisation of the GCC regulatory systems.
Strategy Concept
The Gulf states’ willingness to share their strategies is highly significant for the future of the region, and the following background information underlines why this is important. Although strategy-related terms (e.g. strategic planning, strategic management, strategic thinking) have entered into the literature over the past four or five decades, the focus of attention has been for managers and business development. More recently, however, it has been of interest to healthcare providers.
There are several definitions for strategy, which can be identified, some of which are listed below (Mintzberg 1987). These are:
Strategy is an approach taken by managers that will affect the overall direction of the organisation and will establish the organisation’s future environment.
Strategy is a way an organisation seeks to achieve its vision and mission. It is a forward-looking statement about an organisation’s planned use of resources and deployment capabilities.
Strategy is actions undertaken by managers to attain their goals.
A strategy is way of visualising a future scene and doing everything possible in order to convert future scene into reality.
The Gulf states have developed their internal strategies, which have considerable advantages as well as disadvantages. The advantages of a strategy are that:
It sets the direction of an organisation in order for it to sail cohesively through its environment.
It promotes coordination of activity and to focus effort without a strategy would result in chaos as people pull in different directions.
It defines the organisation and provides a shorthand way for people to understand their organisation and to distinguish it from others and provides meanings plus a convenient way to comprehend what the organisation does.
It provides consistency, reduces ambiguity and provides order, and in this sense, a strategy is like a theory: a cognitive structure to simplify and explain to the world and thereby facilitates action.
The disadvantages of a strategy are that:
Strategic direction can hide the potential dangers that can be encountered during the course of its implementation. Whilst direction is important, it is better to move slowly and carefully without looking too far ahead so that the resulting behaviour can be easily controlled and modified at a moment notice.
‘Group think’ arises when effort is too carefully focused. There may be no peripheral vision, to open other possibilities. A given strategy can become too heavily embedded in the fabric of the organisation.
Every strategy, like every theory, is a simplification that distorts reality. Strategies and theories are not really themselves, only representations (or abstractions) of reality in the minds of people who create them. This means that every strategy can have a misrepresenting or distorting effort. That is the price of having a strategy (Mintzberg et al. 1998).
The Model of Strategic Planning
In pulling together the Gulf states strategies, it is useful to have a ‘model’ to follow. Although different models might have different steps or maybe they vary in the sequence of the steps, the strategic planning process essentially involves three stages and poses the following questions: Where are we now? Where do we want to be in the future? How are we going to get there?
Where Are We Now?
Every profession and every organisation is guided by a set of beliefs and values that communicate its identity and what it stands for. Core values describe collective principles and ideals that guide the thoughts and actions of individuals within an organisation (Zarkesh 2008). Values shape the organisational mission, processes and goals (Seevers 2000), and, therefore, it is critical to determine the values that the GCC authorities live by in order to prepare and implement a successful harmonised strategic plan.
All strategic planning approaches attempt to find an optional match between the resources and capabilities available within the organisation (strengths and weaknesses) and the external market conditions and environmental trends (opportunities and threats). This match or co-alignment, often referred to as SWOT (strengths, weaknesses, opportunities and threats) analysis, results in a strategy, where efficacy translates into some level of corporate performance (Darden School of Business Administration 2009).
Where Do We Want to Be in the Future?
Whilst an organisation must continually adapt to its environmental status, there are certain core ideals that remain relatively stable and provide guidance for the organisation’s strategic direction (Zarkesh 2008; Mintzberg et al. 1998). These ideals are:
The vision statement, which provides a picture of the organisation’s future and allows a framework to be formulated for its strategy
The mission statement, which provides a brief description of the organisation’s fundamental purpose and focuses on its existing status
The visionary goals, which describe what the authority desires to achieve in the future without being specific about when and how much to accomplish
SMART objectives, which determines the specific, measurable, attainable, relevant and time-bound steps that support the organisation’s mission in order to achieve its ultimate visionary goals
Driving forces, which are the motivating factors that every organisation needs to have to be successful in navigating its uncertain future
How Are We Going to Get There?
Given the information obtained from the environmental scanning and the collective core ideals which comprise the fundamental components of the strategic planning process, a strategic planning model can be proposed as an initiative to harmonise the GCC regulatory practices and to pinpoint areas where quality measures are mostly required to improve the registration procedures in the seven GCC authorities. This strategic background provides the rationale as to why this particular study is so valuable to the Gulf region.
There is no perfect strategic planning model for any organisation. Each organisation ends up developing its own approach to strategic planning, often by selecting a model and modifying it (McNamara 2006). This is what makes GCC harmonisation hard to design and /or implement before conducting a full evaluation of each of the seven authorities’ strategies. From this, the resulting commonality can be enhanced whilst the resulting differences minimised. This approach is more flexible and effective than creating a new harmonisation strategy, which can place the authorities under a considerable pressure which may destabilise the entire regional regulatory environment. A stable environment is a critical factor for the success of any strategic plan.
Situational Analysis: Examining the GCC Regulatory Review Process
The regulatory authorities in the seven Gulf states (Table 11.1) provided information on their strategy for improving the review process.
Table 11.1
General information on the seven GCC regulatory authorities
Country | Authority | Date of establishment | Number of reviewers | Budget in US$ |
|---|---|---|---|---|
Bahrain | Directorate of Pharmacy and Drug Control | 1979 | 7 | NA |
Kuwait | Pharmaceutical and Herbal Medicines Registration and Control Administration | 1967 | 15 | 3 M |
Oman | General Directorate of Pharmaceutical Affairs | 1976 | 22 | NA |
Qatar | Directorate of Pharmacy and Drug Control | NA | 3 | NA |
Saudi Arabia | Saudi Food and Drug Authority (SFDA) | 2003 | 40 | 134 M |
UAE | Registration and Drug Control Department | 1980s | 12 | 2.5 M |
Yemen | Directorate General Supreme Board for Drugs and Medical Appliances | 1971 | 10 | 3 M |
In order to establish a clear model for a harmonised strategic plan for the GCC regulatory authorities, it was necessary to define the sequence of activities to be followed. There were different options identified from the literature for the sequence and an appropriate one was chosen for this study. In general, an organisation needs to know exactly where it stands and then determine where it wants to go and how it will get there (Kristofferen 2009). Strategic planning is a creative process and the fresh insight arrived at one stage might easily alter the decision made at a previous stage. Inevitably the process moves forward and backward several times before arriving at the final set of decisions (Zarkesh 2008). Since the seven GCC states have well-established regulatory authorities with robust historical activities, it was hard to imagine a future independent of the past. Therefore, it was more appropriate to carry out the situational analysis (internal and external analyses) before deciding about a realistic approach for the GCC regulatory authority’s directions and future harmonised regulatory strategic plans.
Organisational Values
Organisational values are defined as the collective principles and ideals that guide the thoughts and actions of individuals within an organisation. This study examined the ideas, beliefs, perceptions and attitudes of individuals in the GCC authorities that collectively act as the motivating factors to shape the existing state of the art within each authority. The analysis of the GCC authorities’ core values was based on the sense that employees and managers make of what they do (Rekom et al. 2006). Without such ‘sense-making’ approach, the management will have a hard time implementing a strategy that is compatible with their organisational values (Pant and Lachman 1998). The GCC states have expressed collective values, principles and ideals, which guide their actions for better regulatory services. Twenty-eight values were stated by the seven GCC states, but no one value was common to all authorities. However, seven values were found to be the most prevalent, namely, efficacy, competency, honesty, integrity, professionalism, confidentiality and transparency (Fig. 11.1). The assessment of core values provided critical information necessary to examine the current organisational philosophies and processes and determined congruence within the existing behaviours and practices (Seevers 2000). As an initial step in the strategic planning process, a value audit provided the basis for the decision-making process with regard to the current and future direction of the GCC authorities.
Fig. 11.1
Common Gulf Cooperation Council (GCC) organisational values
Regulatory Internal and External Analysis
The initial steps in the strategic planning process are to address the questions ‘Where are we?’ and ‘What do we have to work with?’ (Yielder and Burns 1999). Examination of the history and changing environment (both internal and external) of an organisation allows the analysis of the current positions of the GCC authorities to be identified. In this study, each authority was found to have a vision statement, a mission statement, goals and objectives. However, it would be meaningless to establish a harmonised future vision without identifying the present strategic resources and capabilities available in the GCC region.
Answering the question of ‘what we have to work with’ involves consideration of the internal and external environment of each GCC regulatory authority. Such analysis of the strategic environment is called the SWOT analysis, and it was carried out in this exercise to identify the strengths, weaknesses, opportunities and threats (SWOT) in the seven GCC regulatory systems. These elements of the SWOT analysis are described as follows (LeDoux et al. 2005):
Strengths and opportunities are positive factors that support current strategies and improved performance.
Weaknesses and threats impede performance and suggest risks in the current strategies.
Strengths and weaknesses indicate internal conditions.
Opportunities and threats indicate external conditions.
Therefore, analysing the strengths, weaknesses opportunities and threats in each GCC authority yields necessary facts to consider when developing the GCC harmonised vision. Each authority has a set of SWOT items that correlate to its position in the GCC regional regulatory environment. Some authorities stated more positive factors (strengths and opportunities) than other authorities depending on their current perceptions about their own distinctive advantages such as Bahrain, Kuwait, Oman, Saudi Arabia and UAE, where they mentioned numerous strengths and opportunities that currently play a vital role in their respective strategies and improved performances.
However, the more positive factors these authorities have, the more risk factors (weaknesses and threats) can emerge to impede their abilities to perform better and capitalise on their distinctive advantages. Qatar and Yemen, for example, stated the fewest positive and negative factors, which would make it hard to embrace their full resources and capabilities to face the constant demands of the regulatory field. This analysis acts as an indicator to highlight the GCC regulatory resources, capabilities, risks and motivating factors that revolutionise the entire concept of ‘Harmonisation of the GCC Regulatory Strategic Planning Process’. Each member state provided a set of strengths and weakness that were perceived to be the internal conditions for the regulatory authorities in the GCC region (Table 11.2).
Table 11.2
Internal conditions within the GCC regulatory authorities
Country | Strengths | Weaknesses |
|---|---|---|
Bahrain | Ministry of health support | Lack of training in certain areas |
Well-trained and experienced staff | Lack of experts in some specialties | |
Active cooperation with other GCC authorities | Low budget | |
Long-experienced system | Shortage of staff | |
Kuwait | Reputable authority in the GCC region | Lack of IT infrastructure |
Long experience in the field | Limited resources | |
Caring, experienced staff | Limited QA measures | |
Influential at the government healthcare level | Dependent authority (not self-sufficient) | |
Oman | Long-term professional experience | Shortage of personnel |
Good legislations | ||
Transparency and honesty | Lack of training in certain areas | |
Team decision-making | ||
Qatar | Experienced system fulfilling local needs | Shortage of experts |
Saudi Arabia | Existing regulatory processes Technical skill set of management | Inconsistent regulations for technology transfer Lack of approval systems to a variety of drugs Lack of adverse event monitoring system Long approval process Pricing disconnected from market demands Weak public education |
UAE | Good experts Guidelines available Electronic system available | Shortage of staff Old laws Dependent department (not self-sufficient) |
Yemen | Equipped central QC lab Appropriate financial resources Independency | Weak legislations Lack of political support Lack of human resources Absence of transparent procedures Absence of priorities Lack of coordination and integration |
The analysis of the internal conditions showed that the GCC region has experienced staff and the required regulatory structure with appropriate legislations, processes and regulations in place supported by an active cooperation between the authorities. However, the experience gained by the staff was obtained from working in the authorities for a long period of time, but it is not able to create experts in new or existing regulatory practices. Therefore, the GCC is lacking the required experts that could enhance its capabilities to advance its system. They also lack the proper training and education programmes to create the required skills and expertise in many fundamental regulatory areas. The analysis of the external conditions demonstrated that the GCC authorities have significant potential to improve their regulatory practices by utilising the opportunity of collaborating with regional and international regulatory agencies.
Furthermore, the GCC authorities seek to employ the emerging technologies to improve their drug approval processes such as the electronic submission of the Common Technical Documents (e-CTD). However, the GCC authorities are faced with high staff turnovers, which affect the balance of experienced personnel required to maintain the standard level of their practices.
An additional problem was the constant danger of an increasing number of substandard and counterfeit drugs from all around the world which combined with the limited resources and capabilities in the region challenges the authorities’ ability to deal with this issue (Table 11.3).
Table 11.3
External conditions within the GCC regulatory authorities
Country | Opportunities | Threats |
|---|---|---|
Bahrain | Independent authority Expand through GCC cooperative efforts Approval of new organisational chart | Poor funding Loss of staff Open market Increasing number of generic medicines Increasing herbal medicines |
Kuwait | Better relations with competent agencies Use of emerging technologies Diversify into various regulatory practices Hiring qualified expert reviewers | Manual work delays regulatory approvals
 Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
Get Clinical Tree app for offline access
|