Research Objectives
Background
What rules decisions in political institutions? Laws? Traditional practice? Rituals? Logics of consequence? Or just chance?
Research has shown that decisions are ruled by all the above. And even more. One important factor when studying decision-making is to look at the organization where the decision is made. My standpoint is in line with basic organization theory – i.e. organizational aspects are in focus of the research.
In 1995 a new pharmaceutical regulation was created for the European Union. It properly was named “The New System”. A central pharmaceutical agency was places in London under the name EMEA – The European Medicine Agency – with the aim to evaluate and supervise medicine for human and veterinary use. The central agency currently works together with all the 25 national agencies of the member states.
Before a pharmaceutical company can market medicines to needing patients in the EU, the specific substance has to be approved by a medical agency. The system in the European Union offers two routes for granting authorization of pharmaceutical substances. Either the company applies for approval to EMEA with the chance of getting approval for all member state of the European Union or the company chooses to apply only to one national medical agency, followed by applications for mutual recognition to all preferable member states. It has been noticed that the different decision-making processes are very different.
What medical agency do the pharmaceutical companies apply to? Why? What is the difference between the decision-making processes at EMEA and the member states’ agencies? Are there differences between the member states? What roll do the differences play for pharmaceutical companies when deciding where to apply? Which single agency is most frequently used, and why? Which one is rarely used, and why? Do the different medical agencies do anything to attract applications?
The aim of the research project is to serve preliminary answers to these questions.
Aim of the research project
In the study I will describe the historical development of the pharmaceutical regulation in the EU since 1995. The aim is to view the pharmaceutical regulation in the European Union as a market. The endeavor is to explain how the political agencies contemplate its relatives (competitors) in adjacent states, and how this contemplation changes their organizational behavior. What effects does the rivalry in the system of regulation have?
The aim is also to explain the behavior of pharmaceutical companies in the process of approval. What issues make them choose decision-making organization, and under what conditions? Has this behavior changed over time, and if so, due to what reasons?
The research project’s objective is to write and publish a descriptive report on the topic of the New System, which both can open up for further discussion and be the base for coming theoretical advancement in Organization Theory.
Methods
The methods in the research project will be fairly straight-forward. To gather statistics from the approval processes will be the first step in the project implementation. Allocation of the processes, cost of application, duration of the processes, and type of medicine in the processes will (among other aspects) be included in the exposition.
A qualitative method will broaden the study. During the fall of 2004 I will conduct interviews with knowledgeable persons from both pharmaceutical companies and medical agencies. During the winter and spring of 2005 I will choose to focus on specific aspects based on my initial exposition of statistics.
Project plan
The research project will be started in September 2004. The initial gathering of will be conducted before the ending of 2004, and a first report will be circulated in January 2005. Meetings with about 20-30 representatives at both pharmaceutical companies and medical agencies will be planned and implemented in the late winter and spring of 2005. A preliminary report will be circulated in the early summer and the aim is to publish the final report in September 2005.
The total time of the research project will from September 2004 and a year ahead add up to research time valid 10 Swedish university credits.
What rules decisions in political institutions? Laws? Traditional practice? Rituals? Logics of consequence? Or just chance?
Research has shown that decisions are ruled by all the above. And even more. One important factor when studying decision-making is to look at the organization where the decision is made. My standpoint is in line with basic organization theory – i.e. organizational aspects are in focus of the research.
In 1995 a new pharmaceutical regulation was created for the European Union. It properly was named “The New System”. A central pharmaceutical agency was places in London under the name EMEA – The European Medicine Agency – with the aim to evaluate and supervise medicine for human and veterinary use. The central agency currently works together with all the 25 national agencies of the member states.
Before a pharmaceutical company can market medicines to needing patients in the EU, the specific substance has to be approved by a medical agency. The system in the European Union offers two routes for granting authorization of pharmaceutical substances. Either the company applies for approval to EMEA with the chance of getting approval for all member state of the European Union or the company chooses to apply only to one national medical agency, followed by applications for mutual recognition to all preferable member states. It has been noticed that the different decision-making processes are very different.
What medical agency do the pharmaceutical companies apply to? Why? What is the difference between the decision-making processes at EMEA and the member states’ agencies? Are there differences between the member states? What roll do the differences play for pharmaceutical companies when deciding where to apply? Which single agency is most frequently used, and why? Which one is rarely used, and why? Do the different medical agencies do anything to attract applications?
The aim of the research project is to serve preliminary answers to these questions.
Aim of the research project
In the study I will describe the historical development of the pharmaceutical regulation in the EU since 1995. The aim is to view the pharmaceutical regulation in the European Union as a market. The endeavor is to explain how the political agencies contemplate its relatives (competitors) in adjacent states, and how this contemplation changes their organizational behavior. What effects does the rivalry in the system of regulation have?
The aim is also to explain the behavior of pharmaceutical companies in the process of approval. What issues make them choose decision-making organization, and under what conditions? Has this behavior changed over time, and if so, due to what reasons?
The research project’s objective is to write and publish a descriptive report on the topic of the New System, which both can open up for further discussion and be the base for coming theoretical advancement in Organization Theory.
Methods
The methods in the research project will be fairly straight-forward. To gather statistics from the approval processes will be the first step in the project implementation. Allocation of the processes, cost of application, duration of the processes, and type of medicine in the processes will (among other aspects) be included in the exposition.
A qualitative method will broaden the study. During the fall of 2004 I will conduct interviews with knowledgeable persons from both pharmaceutical companies and medical agencies. During the winter and spring of 2005 I will choose to focus on specific aspects based on my initial exposition of statistics.
Project plan
The research project will be started in September 2004. The initial gathering of will be conducted before the ending of 2004, and a first report will be circulated in January 2005. Meetings with about 20-30 representatives at both pharmaceutical companies and medical agencies will be planned and implemented in the late winter and spring of 2005. A preliminary report will be circulated in the early summer and the aim is to publish the final report in September 2005.
The total time of the research project will from September 2004 and a year ahead add up to research time valid 10 Swedish university credits.
posted by Svenne Junker at 9:51 pm
0 Comments:
Post a Comment
<< Home