The Hong Kong Association of

the Pharmaceutical Industry

Issue 10 /12 2014 Oct-Dec 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

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

HKAPI Bowling Cup

2014

New HKAPI member

Upcoming Event

Editorial Board

Sabrina Chan

Jenny Wan

Contact Us

Tel: 2528-3061

Fax: 2865-6283

http://www.hkapi.hk/

Email: info@hkapi.hk

Ms. Joanne Fan, Chair of the Code of Practice

Taskforce, welcomed members’ participation and

explained the objectives of the workshop.

Ms. Sabrina Chan, Executive Director of

HKAPI, updated members on the development

of code compliance in Asia.

Ms. Isabella Liu, Honorary Legal Advisor of

HKAPI, highlighted the key provisions in the

UMAO and Trade Description Ordinance.

Ms. Kim Lee, Member of the Code of Practice

Taskforce, shared her experience as a

compliance officer.

Participants presented their views after the group

discussion.

60 representatives from 35 member

companies attended the workshop this year.

ICAC Seminar for Pharmaceutical and Medical Device

Practitioners

The HKAPI and the Hong Kong Medical and Healthcare Device Industries

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

introduced the speaker from ICAC, Mr. Lawrence

Chiu, Senior Community Relations Officer.

Mr. Lawrence Chiu explained the work of ICAC

and the Prevention of Bribery Ordinance.

Mr Benjamin Chan, Vice Chairman of HKMHDIA

thanked ICAC for giving an informative seminar.

Over 50 members from HKAPI and HKMHDIA

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,

explained the submission requirements for

applying clinical trial certificate.

Ms. Kim Lee, Chief Scientific Officer of

Novartis and Chair of HKAPI Clinical Trial

Taskforce, shared good practice in applying

for clinical trial certificate.

Mr. Henry Yau, Managing Director of HKU

Clinical Trial Centre, chaired the panel

discussion.

Panelists from Drug Office (From Left to

Right): Ms. Eva Fung (Pharmacist), Mr.

Frank Chan (Chief Pharmacist), Mr. Vincent

Chow (Senior Pharmacist).

Mr. Lewis Ho, Honorary Legal Advisor of the

HKAPI, discussed with the audience legal issues

when conducting clinical trials in HK.

Audience took the opportunity to clarify their

queries with the Drug Office and also share

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

Pharmacy, University of Hong Kong gave the

opening remarks.

Dr. Ian Douglas, Lecturer, Department of

Non-communicable Disease Epidemiology,

London School of Hygiene and Tropical

Medicine.

Prof. Liam Smeeth, Department Head of

Non-communicable Disease Epidemiology,

London School of Hygiene and Tropical Medicine.

Mr. Kenneth Man, Department of

Pharmacology and Pharmacy of the University

of Hong Kong.

Ms. Sabrina Chan, Executive Director of HKAPI,

thanked HKU and London School of Hygiene and

Tropical Medicine for providing the training to our

members.

Participants having group discussion and

applying what they have learnt in the training

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,

congratulating the graduates on their

achievement.

Professor Vincent Lee, Research Professor

from the Pharmacy School of the CUHK

delivering his speech to the graduates.

Mr. Lot Chan, Chief Pharmacist, Department of

Health gave our graduates some words of

encouragement.

Mrs. Rachel Frizberg presented the souvenir

to our class representatives and also the

masters of ceremony: Ms. Emily Yim and Mr.

Jacky Chow from Sanofi.

78 medical representatives graduated from this

year’s Certificate of Medical Representative

course.

9 graduates made full attendance of 22

lectures for the 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,

introduced the mission and the work of the

Association.

Ms. Annette Chiu from GSK gave an overview of

their 6-month internship program.

Ms. Sarah Tsang from Clinigen introduced the

mission and the services of her company.

Mr. Gordon Lee from Clinigen shared with the

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)

and Mrs. Margaret Rumpf, Board of Directors

kick-started the tournament.

The Team's Champion goes to Sanofi (Team A),

Mrs. Rachel Frizberg presented the award to the

team.

Mrs. Margaret Rumpf, HKAPI Board of Directors,

presented the prize to Men’s Champion, Mr.

Ethan Wong of Sanofi.

Ms. Joanna Yao, HKAPI Board of Directors,

presented the prize to Women’s Champion,

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 info@hkapi.hk