The Hong Kong Association of

the Pharmaceutical Industry

Issue 10 /12 2015 Oct-Dec 2015

In This Issue

HKAPI Joint

Meeting with the

Drug Office

Seminar on the New

Patent Linkage

System in Hong

Kong and its

Implications

Seminar on New

Anti-competition

Guideline and its

Impact on the

Pharmaceutical

Industry

HKAPI Training

Course Graduation

Ceremony 2015

Talk on Internship

Program to HKU and

CUHK

HKAPI Joint Meeting with the Drug Office

On 15 December, the Drug Office and HKAPI organized a joint meeting to brief

members the implementation details of various regulatory changes, in particular

those regulations that will be effective from January 2016.

Pharmacists from the Drug Office first explained the PIC/S GMP requirements for

registration and renewal of pharmaceutical products. Also, the final guidance

notes for the registration of biosimilar products were endorsed by the Pharmacy

and Poisons Board and will be effective on 1 January 2016.

On the registration condition of pharmaceutical products, applicants submitting an

application for pharmaceutical products are required to make a patent declaration

that the product does not infringe the patent rights of other registered products

and it will be suspended for sale or deregistered by the Registration Committee if

found to contravene patent rights.

Apart from the above, sales control of pharmaceutical products for human

parenteral use will be strengthened and become effective in August 2016. Last but

not least, the draft general requirements for master formula and specifications for

non-biological products and the review of regulatory control for Glucosamine and

Vitamins were discussed. About 100 members attended the meeting and the

Association is glad to have the opportunity to understand these important

regulatory changes and members can clarify their queries with the Drug Office.

HKAPI Bowling Cup

2015

HKAPI Cup

(Basketball) 2015

Finals

Editorial Board

Sabrina Chan

Jenny Wan

Contact Us

Tel: 2528-3061

Fax: 2865-6283

http://www.hkapi.hk/

Email: info@hkapi.hk

Mr. Frank Chan, Chief Pharmacist of the Drug

Office, welcomed HKAPI members to join the

meeting.

Ms. Sabrina Chan, Executive Director of

HKAPI, explained the objectives of the joint

meeting.

Panelists from Drug Office at the Q&A section

(From Left to Right): Mr. Clive Chan (Senior

Pharmacist), Mr. Frank Chan (Chief Pharmacist),

Mr. YL Mak (Senior Pharmacist).

Mr. Clive Chan further explained the details of

regulatory changes.

Participants took the opportunity to clarify their

queries.

About 100 representatives from our member

companies attended the joint meeting.

Seminar on the New Patent Linkage System in Hong Kong and

its Implications

Effective from 1st January 2016, the Drug Office of Hong Kong is imposing new

drug registration requirement where applicant of new drug registration needs to

make a non-infringement patent declaration. In view of the above, Dechert,

HKAPI’s Associate Member, hosted a joint-seminar with the Association on 9th

December to provide an overview of the requirements, the potential impact to the

pharmaceutical market in Hong Kong and how different players may be affected.

Mr. Lewis Ho, Partner of Dechert, first introduced the new registration conditions,

the potential liabilities of the declarant in making the non-infringement declaration as

well as the retrospective effect to currently registered drugs and drugs under

renewal.

How patent owner can enforce their rights under the new regime and the pros and

cons of different approaches were then discussed. A case study was used to explain

the impact of the new requirement to enable the audience to have a better

understanding of the change in regulation. Over 50 members attended the seminar

to learn about the impact of the new patent linkage system.

Mr. Lewis Ho, Partner of Dechert, discussed in

details the potential liabilities and impact of the

patent declaration requirements.

Over 50 members attended the seminar on

patent linkage.

Seminar on New Anti-competition Guideline and its Impact on

the Pharmaceutical Industry

The Hong Kong Competition Ordinance has taken full effect on 14 December

2015 where the substantive provisions has come into force and all firms

operating in Hong Kong are required to comply with them. Linklaters, HKAPI’s

Associate Member, very timely organized a seminar on the new anti-competition

guidelines for our members to understand the impact on the pharmaceutical

industry.

Partners from Linklater’s competition team in Hong Kong, China and Europe

spoke at the seminar, Ms. Clara Ingen-Housz from Hong Kong gave an update on

the latest developments in relation to the various Guidelines, enforcement policy

as well as leniency policy published by the Competition Commission and their

impact on the healthcare industry. Ms. Fay Zhou, Partner from China discussed

the recent crack-down on the industry and the significance of the new antitrust

guidelines. Mr. Gavin Robert, Consultant from London also shared with the

audience the development of new theories of harm in Europe and their relevance

in Asia. Members found the roundtable discussion very informative which enables

them to better adapt to the new competition law.

HKAPI Training Course Graduation Ceremony 2015

(Click here for more photos)

With a high passing rate of 97 percent, 63 medical representatives from member

companies including one student with distinction, successfully completed and

graduated from the HKAPI training program. A graduation ceremony was held

on 14th December to honour their dedication to continued learning. HKAPI is

delighted to have Ms. Linda Woo, Assistant Director (Drug), Department of

Health and Professor Joan Zuo, Director and Professor of the Pharmacy School

of the Chinese University of Hong Kong to share their views on the important

qualities that constitute professionals in the pharmaceutical industry and present

the certificates to the graduates. This year, Ms. Carmen Tsui from Kyowa Hakko

Kirin graduated with distinction and 25 students obtained credits.

Mrs. Margaret Rumpf, Vice President of

the HKAPI, gave the opening remarks at

the graduation ceremony.

Ms. Linda Woo, Assistant Director (Drug),

Department of Health, congratulated the

graduates on their achievement.

Professor Joan Zuo, Director and Professor of

CUHK School of Pharmacy, gave our

graduates some words of encouragement.

Ms Carmen Tsui from Kyowa Hakko Kirin

graduated with distinction and received the

certificate from Mrs. Margaret Rumpf.

Mrs. Margaret Rumpf thanked the class

representatives as well as the masters of

ceremony, Mr. Marcus Wong of Servier and

Ms Joann Wong of AstraZeneca for their

contributions.

63 medical representatives graduated from this

year’s Certificate of Medical Representative

course.

Talk on Internship Program to HKU and CUHK

HKAPI members have always been active in providing training including

clerkship and internship to pharmacy students and graduates in Hong Kong.

Currently 10 member companies have been accredited by the Pharmacy

and Poisons Board to provide 6-month internship to pharmacy graduates

from HKU and CUHK. In order to let pharmacy students understand the

operation of Research-based pharmaceutical companies in Hong Kong and

the internship program designed for them, HKAPI and its member

companies have organised a talk to HKU and CUHK on 24th November and

11th December respectively.

During the talks, Ms. Sabrina Chan, Executive Director of HKAPI, first briefly

presented the mission and the focus areas of the Association, participating

HKAPI members then introduced their company background, highlighted

the career pathway for pharmacists in different departments such as

medical and regulatory affairs, clinical research. Details of the 6-month

internship program were also provided and current interns were also

present to share their working experience and what they have learnt during

the internship. The Association would like to thank the support of AbbVie,

AstraZeneca, GSK, and Roche for their informative presentations.

Ms. Sabrina Chan, Executive Director of HKAPI,

introduced the mission and the work of the

Association.

Ms. Rene Chau, Associate Medical Affairs

Manager of AstraZeneca.

Ms. Karen Yuen, Medical Director of AbbVie.

Ms. Emily Kam, Human Resources Manager of

AbbVie.

Mr. Stephen Lee, Associate Director, ACE and

Macau Business Unit, Roche.

Mr. Ronald Leung, Regulatory Affairs Manager

of Roche and their current intern.

Mr. Donald Chong, Head of Regulatory and

Medical Affairs, GSK.

Ms. Tina Chan, Head of Regulatory Affairs

(Hong Kong & Macau Pharmaceuticals), GSK

HKAPI Bowling Cup 2015 (Click here for more photos)

The annual HKAPI Bowling Cup was held on 13th November this year with

great support from members. A total of 25 teams from member companies

participated 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 MSD - Team A, with a high score

of 2568, Sanofi - Team A and Pfizer were the 1st Runner up and 2nd

Runner up respectively.

In the individual division, Mr. Jonan Kwong of MSD won the men’s

championship and the women’s division championship went to Ms. Irene

Tai of Roche. Over 200 members and their family joined the event and

cheered for their colleagues and enjoyed the exciting tournament.

Results of the Bowling Cup

Men’s Division

Champion: Jonan Kwong, MSD

1st Runner up: Sunny Wu, Pfizer

2nd Runner up: Nixon Nip, A. Menarini

Women’s Division

Champion: Irene Tai, Roche

1st Runner up: May Ng, Merck Pharma

2nd Runner up: Doris Fung, MSD

Dr. Sian Ng, President of HKAPI (Middle), Mrs.

Margaret Runpf (Right), HKAPI Vice President

and Ms. Caroline Johnson (Left), General

Manager of AbbVie, kick-started the tournament.

The Team's Champion goes to MSD, Dr.

Sian Ng presented the award to the team.

Ms. Michelle Kehily, Managing Director of

MSD, presented the prize to Men’s

Champion, Mr. Jonan Kwong of MSD.

Ms. Caroline Johnson, General Manager of

AbbVie, presented the prize to Women’s

Champion, Ms. Irene Tai of Roche

25 teams competed for the championship in the Bowling Cup this year.

HKAPI Cup (Basketball) 2015 Finals (Click here for more

photos)

A total of 11 basketball teams participated in this year’s tournament, after several

rounds of competitions that started in early September, the top six basketball

teams that won the most number of matches entered into the finals and the plate

championship which was held on 3rd December.

Pfizer and Sanofi competed for the championship while Janssen and LF Asia

competed for the second runner up. The competitions were very excited with

many colleagues from our member companies cheering for their basketball

teams. The champion finally goes to Pfizer and the second runner-up goes to

Janssen.

Results of the Basketball Cup

Champion: Pfizer

1st Runner up: Sanofi

2nd Runner up: Janssen

3rd Runner up: LF Asia

Plate Champion: Roche

Plate 1st Runner-up: Boehringer-Ingelheim

The Champion goes to Pfizer, Mr. Stephen

Leung, Country Manager of Pfizer

presented the award to the team.

The 1st Runner-up goes to Sanofi, Ms. Kelly

Lam, HKAPI Board of Director presented the

award to the team.

The 2nd Runner-up goes to Janssen, Ms.

Sabrina Chan, Executive Director of HKAPI

presented the award to the team.

The 3rd Runner-up goes to LF Asia, Ms.

Sabrina Chan presented the award to the

team.

Highlights in the Finals: Pfizer vs Sanofi

Highlights in the Finals: Janssen vs LF Asia