RESPONSE TO MSF EMERGING ISSUES - Pharmacy & Poisons Board PARALLEL IMPORTS … 1 4. Allegation that the Board is allowing illegal trade to the detriment of the original manufacturers;

www.pharmacyboardkenya.org

Pharmacy and Poisons Board

RESPONSE TO MSF EMERGING ISSUES DR. KIPKERICH C. KOSKEI,

OGW



MANDATE …1

•  The Pharmacy and Poisons Act, Cap 244 is an Act of Parliament to make better provision for the Control of the Profession of Pharmacy and trade in drugs and poisons. Medical devices are also covered by Legal Notice Number 191 of 2010,and most recently the Gazette Notice No 37 of 21st March,2014.



MANDATE …2

•  The Pharmacy and Poisons Board is established as a body corporate, under the Pharmacy and Poisons Act, Cap 244 Laws of Kenya. The PPB is a pharmaceutical regulatory body within the Ministry of Health.



VISION & MISSION

Vision •  To be a Global Centre of Regulatory

Excellence. Mission •  Safeguard the health of the public by

ensuring that medicines and health products comply with acceptable standards of quality, safety and efficacy.



PPB RESPONSE TO ISSUES RAISED



INTRODUCTION

•  The Pharmacy and Poisons Board took note of the issues raised at the Ministerial Sectorial Forum (MSF) held on 8th May 2015 at the Ministry of Health Headquarters and hereby provides a response to the same.



ISSUES RAISED 1. Allegations that inspectors at the Board are un-professional, unethical and corrupt; 2. Allegations that inspections are not deterrent and they are solely for personal gains; 3. Allegation that PPB does not engage PSK on issues affecting the pharmaceutical sector; 4. Allegation that the Board is allowing illegal trade to the detriment of the original manufacturers. 5. Allegations that PPB does not act on issues raised or way forward agreed upon during stakeholders meetings 6. Allegation that PPB is doing nothing to eradicate quacks (premises operating without licenses and those run by pharmaceutical technologists). 7. Inadequate regulation of Herbal products and Medical Devices 8. Allegation that there is no adequate inspection of colleges, regulation of medical devices and illegal trading 9. Alleged lack of proper chain of command



RESPONSES



INSPECTORS ISSUE …1 1. Allegations that inspectors at the Board are un-professional, unethical and corrupt;

•  PPB inspectors are professionals with minimum training of Diploma in pharmaceutical technology. Some of them have Masters in various pharmacy related Sciences and one has a PhD.

•  Inspections are carried out according to laid down WHO guidelines adopted by the PPB. Sanctions arising out of the inspections are stated in the same guidelines.



INSPECTORS ISSUE …2

•  All inspectors are bound by a Code of Conducts/Ethics that applies to all Public Servants. Any of the inspectors who act contrary to the Code of Conduct/Ethics are punished as per the laid down procedures.

•  Finally there is a robust complaint handling system with an officer designated to receive all complaints written, social media (Facebook, Twitter) or verbal.



INSPECTIONS ARE NOT DETERRENT … 1

2. Allegations that inspections are not deterrent; Over the years inspections have become very effective tools in ensuring compliance with regulatory requirements. •  There are reduced reports of poor quality

medicines •  Increased number of inspections and court

cases for non-compliant e.g. in 2013/2014 the percentage of inspections to court cases was 65.74% and in 2014/2015 the percentage was 59.12%




•  Offenders are arrested and confiscation of all medicines in premises done and goods are only released under court orders.

•  Establishment and equipping of regional offices. •  Gazettement and staffing of ports of entry. •  GPS mapping and real-time inspections of premises •  Licenses are issues with the photo of the superintendent

and can be verified with QR codes •  The board participates in joint inspections with other

regulatory bodies in the health sector




•  The Board has commissioned an elaborate online licensing system that will ensure among others that: –  only registered Pharmacists and Pharmaceutical technologists

can be issued with practicing license –  the professionals have a secure portal to manage their premise

licenses –  only a professional can superintend in the premises –  only pharmacist can superintend in wholesale premises –  that up to date reports can be printed from the system –  professionals can apply and print their licenses from any part of

the country, without necessarily physically coming to the Board. This reduces human to human contact hence mitigate against any mal practices

–  inspection of premises and subsequent reports are incorporated in the system




•  The above not withstanding the Board relies on courts for sanctions which may seem not deterrent to offenders and sometimes the offenders are given back custody of exhibits.



PPB DOES NOT ENGAGE PSK

3. Allegation that PPB does not engage PSK on issues affecting the pharmaceutical sector; •  The membership of the Board of Directors of the

Pharmacy and Poisons Board, comprises of (9) persons •  4 members are nominated by the Pharmaceutical

Society of Kenya (PSK). •  All Board committees have PSK representatives. •  PSK is represented in all stakeholder meetings held

quarterly. •  All guidelines are developed with the input of PSK

among other stakeholders



PARALLEL IMPORTS … 1 4. Allegation that the Board is allowing illegal trade to the detriment of the original manufacturers;

•  Parallel imports are provided for by law under section 58 (2) of the industrial property act.

•  Parallel importation guidelines were discussed by all stakeholders in the Pharmaceutical sectors and approved in September 2006 as a result of tiered pricing (Differential prices) between countries across the world by multinational companies.



PARALLEL IMPORTS … 2

•  The performance contract of the registrar requires comparison of price impact by parallel imports.



STAKEHOLDER RESOLUTIONS

5. Allegations that PPB does not act on issues raised or way forward agreed upon during stakeholders meetings;

•  There are many stakeholders that PPB serves. We have profiled all the stakeholders and developed an annual schedule of meetings. All the issues agreed upon and which PPB is able to handle are dispensed off immediately. However, some issues involve other Government Agencies and PPB only plays a facilitative role. Some of these agencies are KRA, ACA, KEBS, KENTRADE among others.



ERADICATE QUACKS …1 6. Allegation that PPB is doing nothing to eradicate quacks (premises operating without licenses and those run by pharmaceutical technologists); •  The management notes the concern of stakeholders

over illegal pharmacy outlets. It is worth noting that the Board has made tremendous achievements in regulating the practice of pharmacy.

•  There are two cadres of professionals recognized by the Act namely Pharmacists and Pharmaceutical Technologists. The president PSK considers the latter as quacks in his correspondence.



ERADICATE QUACKS …2

•  Ten years ago, 50% of the outlets countrywide were illegal, currently we have made efforts to eliminate illegal outlets most of them in slums and far flung areas. The complaint on illegal outlets (premises without the licenses) will be investigated and acted upon accordingly and this is a continuous process. See 2 above.



HERBAL MEDICINES AND MEDICAL DEVICES

7. Inadequate regulation of Herbal products and Medical Devices;

•  Currently the Herbal products and medical devices are being regulated by the PPB vide legal notice 191/192 of 2010 and gazette notice number 37 of 21st March 2014

•  The practice of herbalists is regulated under different Act administered by the ministry responsible for social services.



HERBAL MEDICINES AND MEDICAL DEVICES

•  The New Application form for Listing of Medical devices and Herbal products has been compiled to collect data on the: –  Applicant in the Kenyan Market –  Details of the Manufacturer –  Registration of their Business in Kenya; –  The Local representative in Kenya –  Particulars of the Herbal product and Medical Device –  Quality management systems by the manufacturer Among others



WEAK REGULATION 8. Weak regulation, inspection of colleges, regulation of medical devices and illegal trading;

•  Application form for Listing of Medical Device is online •  Listing letters issuance takes no more than 30 days •  Control of Import trough Issuance of Listing Letters •  Training workshops on Risk Based Classification of

medical devices •  Licensure of premises is done online •  The Board has put in place several measures to ensure

that pharmacy outlets are operated by professionals. •  GPS Mapping of Registered Premises •  The Board has a well established organogram with clear

chain of command.



WEAK REGULATION …2

•  The Board has guidelines for Accreditation of Institutions offering Pharmacy Training and Registration of pharmacy practitioners. Until January 2015 the president PSK was the Chairman of the committee responsible for accreditation of institutions and registration of practitioners. The committee makes all the decisions.



WEAK REGULATION …3 •  Inspection of training institutions for purposes of

accreditation is conducted for all new pharmacy degree, and diploma training institutions.

•  The Board uses guidelines and tools for the assessment and inspection of colleges.

•  Approved institutions are published regularly and the list is always available online via the Board’s website for public consumption. In the last financial year, the Board accredited United States International University to offer Bachelor of Pharmacy, and Kisumu Polytechnic to offer Diploma in Pharmacy.



CHAIN OF COMMAND

9. Alleged lack of proper chain of command; •  The Board has a well established organogram with clear

chain of command developed by MOH appointed inter-ministerial taskforce. It has well stipulated job descriptions.

•  Every Directorate/departments has fully backed up system and duties and responsibilities spelled out.

•  Attached herewith is a complete organogram that stipulates its chain of command at the Board that is in compliance with statutory requirements of the Government.



CONCLUSION

In conclusion, we wish to state that our doors are open to positive criticisms that lead to improvement of our service delivery to clients.

Documents

RESPONSE TO MSF EMERGING ISSUES - Pharmacy & Poisons Board PARALLEL IMPORTS … 1 4. Allegation that the Board is allowing illegal trade to the detriment of the original manufacturers;