Kuwait Regulatory Review Process is very sensible : Dr. Reem Al-Essa

Dr. Reem Al-Essa is Head of Licensing Division of the Kuwait Drug and Food Control , whose responsibility is to regulate the quality of drugs in Kuwait. The main objective of the interview is to understand the functioning of the Kuwait regulatory review process and details of profession of pharmacy in general in Kuwait.

1.First, let us congratulate you for getting International award by Drug Information Association (DIA) in Boston , U.S.A. Could you please share some information and your feelings with us.

I'm delighted and very proud to be an awarded researcher from Kuwait in such an international venue. I feel so happy to represent my country to the world with the best of my ability in a way that shows how and where our drug and food control agency stands in such a developed regulatory world.

Professor Sam Salek (right), Ms Reem Al Essa, (centre), and Professor Stuart Walker (left)

2. How do you feel having big responsibility as Head of Licensing Division of the Kuwait Drug and Food Control at this young age?

You are absolutely right about the big responsibility part of your question, but I don't think that age matters in this case. It's the eagerness, the excitement, the loyalty and the enthusiasm that I have for my work that is making it so joyful and great to perform. I feel that this responsibility is a wonderful experience for me, I'm learning so much from it. The great thing about this job is that I get to face so many new challenges and new experiences on daily bases. I learn new information about how to manage and control the access and availability of quality, safe and effective medicines to the local patients. You need to be a tough decision maker and a strong-hearted professional, and that is not determined by your age what-so-ever.

3. Could you please explain briefly about Kuwait Regulatory Review Process for approving drugs in Kuwait?

Medicines in Kuwait are regulated for quality, safety and efficacy standards, price control and patent protection. Kuwait has 40 years experience of a regulatory system and plays a prominent role in the GCC region (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates and Yemen). Kuwait is facing an overwhelming regulatory challenge reflecting the rapid advancement of the regulatory services with limited resources possibly influencing patients' timely access to medicines.

As a result, CMR International Institute for Regulatory Science in Surrey, in collaboration with the Centre for Socioeconomic research, Welsh School of Pharmacy, Cardiff University initiated a research project to examine patients' access to medicines in Kuwait, which is the project that I'm currently conducting.

4. What are the major challenges you are facing for approving products in Kuwait?

I believe that the requirements for registering pharmaceutical products in Kuwait are very sensible. We do follow the ministerial decree 302/80 to register the pharmaceutical products which basically include a list of the documents and papers that need to be incorporated in the product registration dossier. Most pharmaceutical companies are very much aware of how the system goes and have minimal problems registering their products. The only major challenge we are facing is when the pharmaceutical companies do not put an effort in following up their products after they submit them to the Drug and Food Control Agency for marketing approval. I really believe that effective communication solves many important issues that cannot be observed by the assessors during the review process. So I do encourage the companies to increase their efforts to better liaise with the drug authority and to work with them under the umbrella of patient safety with an aim to access their safe and effective medicines to the local market.

5. Despite having such great controls by US FDA, still some people lost their lives due to adulterated drugs (contaminated Heparin) from China. What kind of measures in Kuwait taking place to prevent such incidences?

The Drug Inspection Administration of the Drug and Food Control Agency is responsible for observing all the illegalities that are occurring in the pharmaceutical market including adulterated drugs. This is for the drugs that enter the market after they have been approved by the Drug Regulatory Affairs Department. Many drugs, on the other hand, are found to be adulterated before they are approved for marketing in Kuwait. This is done through performing Quality Control Tests that are relevant to a certain product to find out the contents and the labeled amounts of the ingredients used within a product. Once the agency reaches the conclusion that a product is adulterated, a report will be issued to the local agent informing them of the results and warning them of the action to be taken against their product. The action can be anything between cancellation of the product, suspension of the product until further notice, and/or re-shipment of the arriving batches back to the country of origin.

6. What is the classification of health care professions in Kuwait?

a. Medical professionals which include doctors and dentists and

b. allied medical professionals include pharmacists, Nurses, Pharmacy technicians, laboratory technicians, …etc

I hope that one day, pharmacists will be recognized as one of the main medical professions. A pharmacist has a role that cannot be denied and I believe that it is currently the skeleton of the medical field.

7.Are there any pharmaceutical manufacturing companies in Kuwait to support nations needs?

The Pharmaceutical manufacturing environment is not very competitive because of the very small population and the lack of the proper expertise to establish a good base of manufacturing practices for the pharmaceutical products within the country.

Anyhow, to answer your question, we have only one manufacturing company (Kuwait-Saudi Pharmaceutical Industry Co- KSPICO). This company produces generic medicines and aims at covering the local market in Kuwait , in the 7 GCC countries.

8. Please describe the educational system followed for Pharmacists in Kuwait ?

We have a faculty of pharmacy that graduates approximately 40 students per year. It's a small number since it's a fairly new university which is only few years old.

Kuwait Pharmaceutical Association plays a good role in providing proper continuous education lectures for pharmacists who need to improve and refresh their knowledge in Pharmacy.

KEMS is also a points system where pharmacists are required to attend a certain number of educational programs to collect points for improving their profession.

9. What is the average salary for a pharmacist in Kuwait ?

A pharmacist in Kuwait can earn anywhere between 750 to 3000KD per month

The average Salary could be about 1200-1600KD per month

10. What are your future goals?

My main goal is to reach a satisfying level of knowledge, experience, and networking and to be ready to take any vital, important and high ranking role within the Ministry of Health.

My main objective is to complete my PhD program by the end of 2010 after-which I'm looking for more challenges within the pharmaceutical regulatory field.

Thank you very much. Dr.Reem. Pharmainfo.net team wishes you best of luck for your future endeavors.