86-10-65907696About Legal Working Group
A) The Portfolio of the Legal Working Group:
The PORTFOLIO of the Legal WG has developed for the past few years to cover the following three areas:
1. IP Policies – This is an area where the current laws/regulations either are not clear/specific enough to ensure meaningful protection of IP relevant to our Industry, or as we see it, are not strong enough to stimulate pharmaceutical R&D in China. Issues in this area are sometimes referred to as the “lifeline” of our Industry. Data exclusivity, patent linkage and Patent Law revision (Patent Term Restoration) for example, fall under this category of the portfolio.
2. Law enforcement – Our main concern over law enforcement in China relates to the anti drug-counterfeiting initiative, including actions to support the updating of laws, regulations or judicial interpretations in the field, or enforcement-related campaigns against drug-counterfeiting launched by the government. The J.I.s on the Anti Drug Counterfeiting provisions of the Criminal Code and the bulk chemical issue are currently under the category of “law enforcement”.
3. Code of Promotional Activities – This new area of focus is receiving more and more attention from the Member companies, both from legal and internal compliance point of view. The consensus is that Industry has to take actions to enhance its self-regulation standard and level the playing field across the Industry in order for our Industry to further distinguish itself in the eyes of the key stakeholders.
4. Other legal policy issues – affecting our Industry, including mainly legislative initiatives that have significantly implication on our Industry such as the issuance or revision of the Drug Administration Law, the Anti Monopoly Law, the Labor Contract Law etc.
B) The Structure of the Legal Working Group:
The STRUCTURE of the Legal Working Group has developed accordingly to include the following constituents:
Supervisors: Executive Committee (EC), Allan Gabor (Regional President/Pfizer as the EC Advisor of the WG; and James Liu, Managing Director of RDPAC.
Legal WG (or “WG”), consisting of the Legal Directors (or its delegate approved by the GM) of the Member Companies. In principle, each and every Member Company should assign one (1) representative to the Legal WG.
Sub-WGs under the Legal WG:
1. IP Policy – Legal WG Members plus volunteered GA Directors.
2. Anti Counterfeiting Taskforce – Legal WG Members plus Global Security Officers.
3. Code Taskforce – Legal WG Members plus Compliance Officers.
4. A proposed group of “Core Members” is to be established, which consists of eight (8) Legal Directors and three (3) compliance officers with each representing one (1) company, and which routinely convenes and makes decisions/proposals, as appropriate, on the projects or action plans undertaken by the Legal WG.
Member Qualifications – A Legal WG or Sub-group Member is required to:
1. represent his/her Company in the (Sub-)WG;
2. consistently participate in and contribute to the discussion and/or decision-making process of the (Sub-)WG; and in order to be an active participant;
3. make the best effort to fully understand the background of the issues and help explore the best possible positions/solutions for the WG/Industry;
4. contribute or help secure resources necessary to advance the (Sub-)WG agenda;
5. be committed to seeking consensus and alignment among the (Sub-)WG, and if applicable, within the Industry.
