2014 - hkapi

The Hong Kong Association of
the Pharmaceutical Industry
Issue 10 /12 2014
In This Issue

HKAPI Code of
Practice
Train-the-trainer
Workshop

ICAC Seminar for
Pharmaceutical and
Medical Device
Practitioners

Consultation for
2015 Policy Address

Best Practice Sharing
Workshop for
Applying Clinical
Trial Certificate

Seminar on Hong
Kong Competition
Ordinance
Oct-Dec 2014
HKAPI Code of Practice Train-the-trainer Workshop
With very positive feedback from last year’s Train-the-trainer Workshop, the Code
of Practice Taskforce has decided to make it an annual event and the Workshop
was held on 17th October with 60 representatives from 35 member companies
attending.
After the opening remarks from Ms. Joanne Fan, Chair of the Code of Practice
Taskforce, the Workshop began with a presentation from Ms. Sabrina Chan,
Executive Director of HKAPI, where she gave an update on the development of
industry code of practice in Asia and introduced some useful toolkits on
compliance training.
Ms. Isabella Liu, Partner of Baker & McKenzie and Honorary Legal Advisor of
HKAPI, then in her presentation highlighted the relevant provisions in the
Undesirable Medical Advertisements Ordinance, Trade Description Ordinance
and the Public Health and Municipal Services Ordinance that members should
pay particular attention when approving promotional materials and interacting with
the lay public.
In the second part of the Workshop, participants were divided into groups and
studied the cases developed and facilitated by the Taskforce members. After a
detailed discussion, members presented their views and highlighted the relevant
clauses of the Code they made reference to when making decisions.
Last but not least, Ms. Kim Lee, Member of the Code of Practice Taskforce,
shared her experience as a compliance officer and some good practices on how
to track whether the company complies with company policies, industry code and
international standards on different aspects such as promotional materials,
interaction with healthcare professionals.

Training on Drug
safety and
Pharmacoepidemiology

HKAPI Training
Course Graduation
Ceremony 2014

CUHK Internship
Briefing

Ms. Joanne Fan, Chair of the Code of Practice
Ms. Sabrina Chan, Executive Director of
Taskforce, welcomed members’ participation and
HKAPI, updated members on the development
explained the objectives of the workshop.
of code compliance in Asia.
Ms. Isabella Liu, Honorary Legal Advisor of
Ms. Kim Lee, Member of the Code of Practice
HKAPI, highlighted the key provisions in the
Taskforce, shared her experience as a
UMAO and Trade Description Ordinance.
compliance officer.
Participants presented their views after the group
60 representatives from 35 member
discussion.
companies attended the workshop this year.
HKAPI Bowling Cup
2014

New HKAPI member

Upcoming Event
Editorial Board
Sabrina Chan
Jenny Wan
Contact Us
Tel: 2528-3061
Fax: 2865-6283
ICAC Seminar for Pharmaceutical and Medical Device
Practitioners
http://www.hkapi.hk/
The HKAPI and the Hong Kong Medical and Healthcare Device Industries
Email: [email protected]
Association (HKMHDIA) jointly invited ICAC to give a talk to their members on
anti-corruption legislation in Hong Kong. Mr. Lawrence Chiu, Senior Community
Relations Officer of the Hong Kong Ethics Development Centre first introduced the
work of ICAC and highlighted the corruption prone areas in the healthcare industry.
Different sections of the Prevention of Bribery Ordinance were then explained in
details and illustrated with cases from various business sectors. Corruption
Prevention Guide for SMEs in Guangdong, Hong Kong and Macao were discussed.
Mr. Chiu also shared with members the range of services provided to the healthcare
industry such as consultancy services on corporate ethics programme, review of
internal control systems and business and professional ethics training.
Ms. Sabrina Chan, Executive Director of HKAPI
Mr. Lawrence Chiu explained the work of ICAC
introduced the speaker from ICAC, Mr. Lawrence
and the Prevention of Bribery Ordinance.
Chiu, Senior Community Relations Officer.
Mr Benjamin Chan, Vice Chairman of HKMHDIA
Over 50 members from HKAPI and HKMHDIA
thanked ICAC for giving an informative seminar.
attended the seminar.
Consultation for 2015 Policy Address
As in the previous years, Mrs. Carrie Lam, the Chief Secretary for Administration
has invited HKAPI to the Policy Address consultation to provide our views on
healthcare policy. Mrs. Margaret Rumpf, Board of Directors, attended the
consultation session on behalf of the Association and expressed our views.
First and foremost, drug accessibility should be improved by increasing the drug
expenditure, which currently stands at 0.5% of GDP only as compared to 1.5%
in other advanced countries such as Australia and Korea. Also, the availability of
medicines which are newly enlisted in the Drug Formulary varies greatly across
different hospitals, in some cases, it has taken more than 2 years for patients to
get access to the new drugs. We believe patients who receive treatment from
different clusters should have equal access to new medicines.
Secondly, it is also important to have a comprehensive policy on rare
diseases to ensure patients with rare diseases have access to treatment as
patients with commonly diagnosed diseases. A comprehensive policy should
encompass different aspects of disease management from drug registration
procedure, separate funding for treatment to screening and early diagnosis of
patients with rare diseases.
This move would bring Hong Kong in line with
other advanced healthcare systems such as Australia, Japan, Korea and
Taiwan.
Best Practice Sharing Workshop for Applying Clinical
Trial Certificate
On 10th November, HKAPI’s Clinical Trial Taskforce jointly organized a best
practice sharing workshop for applying clinical trial certificate for members
and contract research organizations (CROs) with the Drug Office. In the first
session, Ms. Eva Fung from the Drug Office gave a presentation on the legal
framework, submission requirements for applying clinical trial certificate and
the common gaps in the application dossiers. Ms. Kim Lee, Chief Scientific
Officer of Novartis and Chair of Clinical Trial Taskforce, then shared with
members some practical tips on how to prepare a first time right clinical trial
certificate application file. A panel discussion facilitated by Mr. Henry Yau,
Managing Director of HKU Clinical Trial Centre then followed where
colleagues from the Drug Office discussed and answered queries raised by
members. In the second session, Mr. Lewis Ho, Partner of Dechert and
Honorary Legal Advisor of the Association, discussed common legal issues
faced in clinical trial studies including Indemnity, non-resident study subjects,
study site monitoring, data privacy issues and survival follow-up with the use
of some practical case studies to illustrate.
Over 50 HKAPI members and representatives from CROs participated in
the workshop and regarded it as a very useful way to share and learn good
practice in the application of clinical trial certificate and conducting clinical
studies.
Ms. Eva Fung, Pharmacist of the Drug Office,
Ms. Kim Lee, Chief Scientific Officer of
explained
Novartis and Chair of HKAPI Clinical Trial
the
submission
requirements
for
applying clinical trial certificate.
Taskforce, shared good practice in applying
for clinical trial certificate.
Mr. Henry Yau, Managing Director of HKU
Panelists from Drug Office (From Left to
Clinical
Right): Ms. Eva Fung (Pharmacist), Mr.
Trial
Centre,
chaired
the
panel
discussion.
Frank Chan (Chief Pharmacist), Mr. Vincent
Chow (Senior Pharmacist).
Mr. Lewis Ho, Honorary Legal Advisor of the
Audience took the opportunity to clarify their
HKAPI, discussed with the audience legal issues
queries with the Drug Office and also share
when conducting clinical trials in HK.
their company practice.
Seminar on Hong Kong Competition Ordinance
In light of the recent publication of the Draft Guidelines by the Competition
Commission, which outline how the Commission expect to interpret and apply the
three competition rules in the Ordinance, the HKAPI together with Associate Member
Linklaters, organized a seminar on Hong Kong Competition Ordinance on 13th
October for members to understand the impact of the Ordinance on the
pharmaceutical companies as well as the industry association.
We are delighted to have Ms. Clara Ingen-Housz, Mr. Gavin Robert and Ms. Anna
Mitchell from Linklaters, who have considerable expertise in the area of competition
law, to talk about the key provisions of the Competition Ordinance, the investigation
process, the common pitfalls for industry associations and pharmaceutical
companies in Hong Kong. Last but not least, speakers also shared with members
some practical tips for successful compliance with the competition law through the
implementation of effective compliance programmes.
Training on Drug safety and Pharmacoepidemiology
Following the successful collaboration with the Pharmacy School of the University
of Hong Kong on regulatory training in May, HKAPI and HKU co-organized a
two-day training on drug safety and pharmacoepidemiology in late October for our
members as well as colleagues from the Drug Office and HKU. Experts from the
London School of Hygiene and Tropical Medicine were invited to conduct the
training, Dr. Ian Douglas introduced frequently used observational study designs
employed in pharmacoepidemiology including descriptive, cohort and case control
studies. Prof. Liam Smeeth discussed selection and information bias in
epidemiological studies. Basic statistical concepts in pharmacoepidemiology such
as statistical significance, odds ratio, relative risk were then explained by Mr.
Kenneth Man from the University of Hong Kong.
The focus of Day Two is to let participants put into practice what they have learned
in the first day in the format of statistic workshop and paper discussion group led by
Mr. Kenneth Man and Dr Ruth Brauer from the London School of Hygiene and
Tropical Medicine respectively. About 60 members and colleagues from the Drug
Office participated in the 2-day training which deepened their understanding on
epidemiological studies.
Prof. Ian Wong, Head of Pharmacology and
Dr. Ian Douglas, Lecturer, Department of
Pharmacy, University of Hong Kong gave the
Non-communicable Disease Epidemiology,
opening remarks.
London School of Hygiene and Tropical
Medicine.
Prof. Liam Smeeth, Department Head of
Mr. Kenneth Man, Department of
Non-communicable Disease Epidemiology,
Pharmacology and Pharmacy of the University
London School of Hygiene and Tropical Medicine.
of Hong Kong.
Ms. Sabrina Chan, Executive Director of HKAPI,
Participants having group discussion and
thanked HKU and London School of Hygiene and
applying what they have learnt in the training
Tropical Medicine for providing the training to our
members.
HKAPI Training Course Graduation Ceremony 2014
(Click here for more photos)
This year 78 medical representatives from member companies successfully
completed and graduated from the HKAPI training program, which is equivalent to
a passing rate of 100 per cent. A graduation ceremony was held on 9th December
to honour their hard work. HKAPI is delighted to have Professor Vincent Lee,
Research Professor from the Pharmacy School of the Chinese University of Hong
Kong and Mr. Lot Chan, Chief Pharmacist of the Drug Office, Department of Health
to give words of encouragement and present the certificates to the graduates.
Mrs. Rachel Frizberg, President of the HKAPI,
Professor Vincent Lee, Research Professor
congratulating
from the Pharmacy School of the CUHK
the
graduates
on
their
achievement.
delivering his speech to the graduates.
Mr. Lot Chan, Chief Pharmacist, Department of
Mrs. Rachel Frizberg presented the souvenir
Health gave our graduates some words of
to our class representatives and also the
encouragement.
masters of ceremony: Ms. Emily Yim and Mr.
Jacky Chow from Sanofi.
78 medical representatives graduated from this
9 graduates made full attendance of 22
year’s Certificate of Medical Representative
lectures for the course.
course.
CUHK Internship Briefing
To enable students from the Pharmacy School to have a better understanding
of the internship program that will be provided by the pharmaceutical
companies in Hong Kong, the Chinese University of Hong Kong has invited
HKAPI and its members to give a briefing on 13th November. Two member
companies, GSK and Clinigen participated in the briefing. After a brief
introduction of the Association by Ms. Sabrina Chan of HKAPI, Ms. Annette
Chiu, Regulatory & Medical Affairs Director of GSK presented the key
functions of different departments of an R&D based pharmaceutical company
and the training modules of their internship program.
Ms. Sarah Tsang, Director of Human Resources of Clinigen then shared with
the students the mission, milestones and the pharmaceutical distribution
solutions provided by the company. As a graduate from the Pharmacy School,
Mr. Gordon Lee, Business Development Manager of Clinigen also shared with
the students his working experience and career development in the
pharmaceutical industry.
Ms. Sabrina Chan, Executive Director of HKAPI,
Ms. Annette Chiu from GSK gave an overview of
introduced the mission and the work of the
their 6-month internship program.
Association.
Ms. Sarah Tsang from Clinigen introduced the
Mr. Gordon Lee from Clinigen shared with the
mission and the services of her company.
students his career development in the
pharmaceutical industry.
HKAPI Bowling Cup 2014 (Click here for more photos)
The annual HKAPI Bowling Cup was held on 7th November this year with the
participation of 23 teams from member companies to compete for the
championship as well as the individual award in the men's and women's division.
Each team member bowled three games in the keen competition. The overall
team championship finally went to Sanofi - Team A, with a high score of 2421,
MSD and Boehringer Ingelheim were the 1st Runner up and 2nd Runner up
respectively.
In the individual division, Mr. Ethan Wong from Sanofi won the men’s
championship and the women’s division championship went to Ms. Alice
Leung of AstraZeneca. About 200 members joined the event and enjoyed a
great evening with their colleagues and family.
Results of the Bowling Cup
Men’s Division
Champion: Ethan Wong, Sanofi
1st Runner up: Joseph Chou, Sanofi
2nd Runner up: Jelson Yuk, Baxter
Women’s Division
Champion: Alice Leung, AstraZeneca
1st Runner up: Doris Fung, MSD
2nd Runner up: Tracy Ng, LF Asia
Mrs. Rachel Frizberg, President of HKAPI (Right)
The Team's Champion goes to Sanofi (Team A),
and Mrs. Margaret Rumpf, Board of Directors
Mrs. Rachel Frizberg presented the award to the
kick-started the tournament.
team.
Mrs. Margaret Rumpf, HKAPI Board of Directors,
Ms. Joanna Yao, HKAPI Board of Directors,
presented the prize to Men’s Champion, Mr.
presented the prize to Women’s Champion,
Ethan Wong of Sanofi.
Ms. Alice Leung of AstraZeneca.
23 teams competed for the championship in the Bowling Cup this year.
New HKAPI Members
HKAPI is pleased to welcome MD Events Limited who joined as Associate
Member in October 2014.
MD Events Limited
Since 2002, MD Events has been a global strategic meeting management
partner for clients in the life sciences industry. With five wholly-owned offices in
Europe, the United States, Russia, Asia and Latin America, a global compliance
staff, our high-touch registration process, and our consultative approach to
meeting design, we successfully create engaging, memorable meetings resulting
in a 97% repeat business rate. To learn more about MD Events, including a
schedule of upcoming speaking engagements and industry events, visit:
www.md-events.com
Upcoming Event
HKAPI Annual Dinner
The 46th HKAPI Annual Dinner will be held on 26th January, 2015 and we are
very delighted to have Dr. Constance Chan as our guest of honour.
Details of the Annual Dinner are as follows:
Date: 26th January 2015
Time: 6:45 pm - 10:00 pm
Venue: Salon 1-5 (Level 3), JW Marriott Hotel Hong Kong
For enquires and RSVP: Please contact Ms. Idy Wong at [email protected]

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