Session for Industry Feedback and Suggestions on Proposed Bill on Temporary Measures to Reduce the Impact of Covid 19 - 3rd June 2020
The Ministry of International Trade and Industry sent out a communication to associations and professional bodies last week to provide feedback on said proposed bill. MAPS sent a list of proposals on 30th May. Many associations also sent in their proposals. A session was called to discusss the gathered feedbacks scheduled on 3rd June 2020 at 2.30 - 4.30 PM. As expected this session as in previous meetings overshot the allocated time.
|Above - the queue registering to enter the ballroom at MITI|
This meeting chaired by the Deputy Secretary General of MITI, had representatives from various government agencies and departments
- Department of Legal Afffairs, PM's Department
- Procurement Department, MOF
Delegates of 95 Associations from industrial sector and 33 from professional sector were invited to this meeting. It was disclosed at this meeting that a total of 220 proposals were submitted by the industrial sector and 61 were from the services sector. The major proposals fall into 6 categories
The delegates were informed that such issues will not be covered under the proposed bill
- Contractual Obligations, with general provisions which extends to force majeure principals to Covid-19 situations
- Allowance for online meetings and declarations
- Extension and relaxation of statutory requirements, including winding-up and bankruptcy
- Sustainability of employers through relaxation of Labor Law requirements, tax measures and cash rebates
- Review of insurance coverage to make available temporary short term coverage of those facing increased risk of Covid-19
- Mediations initiative to resolve disputes post Covid-19
The delegates voiced opinions on the various exclusions mentioned above and urged the government agencies to look at ways, for example if possible to harmonise state and federal legislations.
- Under state jurisdiction
- Can be resolved by the powers of respective Ministers by way of subsidiary legislation
- Can be resolved administratively by their respective Ministries / Agencies / Departments
- Contractual issues that can be resolved by contracting parties (freedom of contract)
While the purpose of this meeting was to discuss the bill, some discussions strayed into the area of SOPs as there remains lack of clarity resulting in frustrations to the business community.
Finally, if you have any proposal or feedback on the Covid 19 bill, it is not too late to send them to the Ministry. Please provide it via this
Session for the clarification of SOPs for industrial sectors during MCO period - 19th May 2020
This meeting was chaired by the Secretary General of the Ministry of International Trade and Industy, Y Bhg Dato' Lokman Hakim Ali at the Dewan Perdana of the Menara MITI. This meeting was attended by 11 government agencies/ministries, including the DG Health, Perkeso, KPDNHEP, KDN, BNM and MKN. The private participants were from 130 associations and professional bodies.
This session saw the DG Health Datuk Seri Dr. Noor Hisham bin Abdullah, updating the delegates on the situation in the country. It was highly interactive, started on time and went into overtime by more than an hour. Even then there were still some pressing issues that needed to be raised via the WhatsApp group for further consideration.
It was acknowledged by the government representatives that while Covid-19 affects health, it has also affected wealth via its impact on the economy. Tacitly the virus is already in our community and will be here to stay. The planning to manage the crisis was started in December 2019 when the first cases broke. The first case in the country was recorded on 25 Jan 2020, mostly imported cases from China and Malaysians related to Chinese contacts. Whle there was a 11 day lull towards late February, the storm of patients came following that. The government was advised to close the borders to stem the tide, resulting in the implementation of the MCO.
There are new things being learnt about the virus, as what was initially thought to be an infection that affected the airway, has now shown to also affect other systems like the vascular and immune systems. It is also learnt that the virus is evolving, and the prospects of a vaccine remains elusive due to that. As such Malaysians must be prepared to change our way of interacting to maintain the flattening of the curve. In the time since the CMCO, the cases have started to decline, and at some points even reached single digit infections, barring the imported and foreign worker clusters. The situation at the hospitals have improved. Of the 7 Covid-only hospitals, ventilator utilization has fallen to below 5%.
The meeting discussed many issue related to screening, testing, the implementation of SOPs, funding and dealing with the conflicting statements from various bodies. The delegates requested that there be more clarity and unity on the policies to allay fears of the industry.
Finally, Selamat Hari Raya Puasa, dear members. Even if we have to do things differently this year, the same spirit of love and respect for life and each other should prevail. We may be physically distant, but let us keep each other close in our thoughts and hearts.
Meeting to Discuss Operation of Industry Sectors during MCO period - 28th April 2020
A meeting was called by the Ministry of International Trade and Industry on April 28th, chaired by the Deputy Secretary General (Industry) of MITI, Y Bhg Dato' Sri Norazman Ayob. This meeting saw representations by over 30 associations.
Among the key highlights of the meeting included the presentation by Dr Mahesh of the Cricis Preparedness Response Center of the Ministry of Health, on the MySejahtera app. Members are strongly encouraged to have staff and visitors to their premises instal this app. The MAPS secretariat has sent out the circular on this matter. The implementation of similar apps has been taken up in many countries helping the countries manage the pandemic.
On the technical matters relating to the approval to continue operations, MITI has highlighted that the process involves multiple agencies. MITI is cognisant of the need for industry to operate, but there are limitations set by other agencies, such as town or municipal councils and city halls.
Moving forward both the EPU and Ministry of finance are working towards measures to help the economy recover. The meeting was told to anticipate some imminent good news. (Post-meeting press release, ie the good news) it has been announced that limitations on number of staff and operation hours have been lifted. But with this relaxation, companies are expected to be self-policing to ensure that the SOPs are rigidly adhered to. Companies who abuse the relaxation will have their operations shut down.
First BOD meeting of 2020
MAPS had its first Board of Directors meeting at the Secretariat on 18 February 2020. This also marks the first meeting for the decade. We hope that with the turn of the decade more good things will come.
One important matter discussed is the upcoming dialogue with the NPRA scheduled for March.
We also look forward to meeting our members in the Annual General Meeting scheduled for 10.30 am March 19th. We hope to have a participative meeting. Lunch will be served.
NPRA Engagement with the Private sector
MAPS represented by TF Heng, Mathew John and Christine Yim participated in the "NPRA Engagement with the Private sector" on 14th February 2020. There were 2 parts to the presentation viz:
Part 1: New Amendments for the Fee Schedule under CDCR 1984. This was also uploaded to the Unified Public consultation website
www.upc.mpc.gov.my for public feedback and comments by 14th April 2020. , and
Part 2: Regulatory Updates 219-2020 & Strategic Plan 2021-2024
MAPS raised its concerns for the hefty increase in the fees proposal.
Pharmaceutical Industry Pharmacists Insight 21 Dec 2019
MAPS was invited to be on the panel for the topic "A Paradigm Shift in Profession Landscape?: Saturation, Juxtaposition, Empowerment". The panel was a program within the Pharmaceutical Industry Pharmacists Insight organised by the Young Pharmacists Chapter of MPS.
MAPS was represented by the President Mr Lim together with panelists from Pharmacy Board, MPS, MOPI and Phama.
MAPS presented views on the opportunities within the industry relevant to our members' business, such as GDP, regulatory and entrepreneurship, amongst others.
MAPS 8th Anniversary Dinner
MAPS celebrated her 8th anniversary at the Holiday Inn Glenmarie, Shah Alam with nearly 300 participants from member companies and invited guests on 18 October 2019.
We had, as Guest-of-Honor, Dr Ramli Bin Zainal, the Senior Director of the Pharmaceutical Services Programme, Ministry of Health represented by Datin Dr Faridah Aryani Binti Md Yusof, Director of the National Pharmaceutical Pharmacy Regulatory Agency.
The photos have been posted at this link
Click for Datin Dr Faridah's speech
Click for President's speech
Good Governance in Medicines Seminar - 30th October 2019
The Pharmacy Services Program, MAPS, MPS, MOPI, PhAMA and MCPG co-organised the Good Governance for Medicines (GGM) Seminar on the 30th October 2019 at the Grand Dorsett Hotel, Subang. The theme was: “Governance and Integrity, The Way Forward”.
The Seminar was to increase the awareness of professional and stakeholders in the healthcare industry on the importance of good governance in medicines. Among issues covered were the National Anti-corruption Plan, MoH Policies on Corruption, Code of Conducts of the Trade Associations and professionals.
Mr TF Heng, Vice President, represented MAPS at the Panel discussion.
Hologram Dialogue Session - 17th August 2019
The Enforcement Unit of Pharmacy Division of the Ministry of Health and the Industry Stakeholders on the new Supplier for the “Hologram” labels held a dialogue on 17th August. Techno Secure Print Sdn Bhd (TSP), will be the new Supplier for the “Hologram” labels effective 1st September 2019 – 31st August 2023. Purchases of the “Hologram” will be effective this date. However, the use of the existing Meditag Hologram will be allowed to continue in order to “finish” the stock or within a 1-year period.
CONFERENCE FOR PREPARATION OF MALAYSIA STRATEGIC 12TH PLAN PAPER AKA RANCANGAN MALAYSIA (RMKe-12)
A conference was held at the brand new National Institute of Health, Setia Alam for the purpose of preparing the 12th Malaysia Plan (RMK12) on the 15th of August. Many stakeholders from both the public and private sector was invited to listen to the varous presentations before the participants were divided into 14 focus groups to prepare the 5 year paln for the Health sector. MAPS was represented by the President.
A very important presentation by the Minister who himself spent over an hour on the topic of National Health Reform drew the major attention in addition to 3 more lectures by eminent luminaries. Members have the privilege of logging in to the members section to view the Minister's presentation.
Datuk Dr Christopher Lee, Deputy DG Health(Research & Technical Support)
Representative from Ministry of Economic Affairs
Dato' Dr. Chong Chee Kheong, Deputy DG Health(Public Health)
Datuk Dr Hj. Rohaizat bin Hj Yon, Deputy DG Health(Medical)
Dato’ Seri Dr Chen Chaw Min, Secretary General, MOH
Datuk Seri Dr. Dzulkefly Ahmad, Minister of Health
FOCUS GROUP PUBLIC PRIVATE PARTNERSHIP (PPP) FOR PREPARATION OF MALAYSIA STRATEGIC 12TH PLAN PAPER AKA RANCANGAN MALAYSIA (RMKe-12)
A multi stakeholder meeting was called by the Bahagian Perkidmatan Farmasi was chaired by the Senior Director Dr Ramli Zainal on August 2nd. MAPS was represented by the President at this focus group.
Notable participants were from
A follow up meeting is planned for 9th August
- Bahagian Perkhidmatan Farmasi
- National Pharmacutical Registration Agency
- Bioeconomy Corporation Malaysia
- Association of Private Hospitals Malaysia(APHM)
KOTRA Courtesy Call - 27 Jul 2019
KOTRA is the Korea Trade Investment Promotion Agency. Mr Ryu Youngkyu and Ms Ong Shu Yi from KOTRA paid a courtesy call on 31st July 2019 at MAPS Secretariat inviting MAPS members to attend the upcoming trade event hosted by KOTRA (27th August). The MAPS Secretariat has sent out the invitations to members on 18th July. Members who are interested are advised to respond directly to KOTRA.
MAPS shared with KOTRA some of the experiences of member companies who are working with Korean companies. Some major challenges for Korea products highlighted are
- high pricing
- registration dossiers
- product categorization between the Malaysia and Korea Regulatory Authorities
- minimum batch purchase/order quantity
- product dosage availability
Dialogue: Medicine Price Control - 21 Jun 2019
The Malaysian Cabinet approved “Medicine price controls” in early part of the year. The MoH together with the Ministry of Domestic Trade and Consumer Affair (KPDNHEP) will be utilising the Price Control and Anti-Profiteering Act 2011 to regulate the medicine prices.
MAPS participated in a Dialogue – “Can price controls ensure affordable and quality healthcare in Malaysia?” organised by the “Galen Centre for Health and Social Policy” on 21st June 2019 at the PJ Hilton.The dialogue provides a platform for stakeholders to discuss the Govenment’s intent to impose price controls. Participants were from relevant government ministries, pharmaceutical and healthcare technology industry, insurance and academia.
Dialogue Cash Usage by Consumers for purchase of goods and services - 13 Jun 2019
A dialogue session on “Cash Usage by Consumers for purchase of goods and services” was held on 13th June 2019 with delegates from Bank Negara Malaysia (BNM). BNM's intent was to explore and drive the increased utilisation of digital/internet banking payment platform for trade transactions in the private sector. BNM has noted that our industry is highly compliant with the rules such as Know Your Customer (KYC) due to our highly regulated environment. We also gave feedback on the difficulties faced by our customers in switching to e-banking, and the team will look into this.
(L to R): TF Heng, Choe Tong Seng, Rahman Krishnan, John Leng, TC Lim, Subramaniam, Shamsul, Muhamad Izzat, Normasita Sidek
MPS Medicine Price Forum - 27 April 2019
As a program within the Malaysian Pharmaceutical Conference 2019, a panel discussion on the captioned subject was held at the Istana Hotel. MAPS President was one of the invited panelists for the forum. For more coverage, please visit the report which was reported in the Star on 16 June 2019.
Photo by S.S.Kanesan/The Star
Townhall Session Hon Health Minister with Pharmaceutical Stakeholders - 2 Apr 2019
A Townhall session with all stakeholders in pharmaceutical industries led by YB Datuk Seri Dzulkefly, Minister of health was held in the afternoon of 2nd April 2019 in Putra Jaya. The Minister was accompanied by the Ministry's Secretary General, Director General, Deputy Director General (Medical) and Senior Director of Pharmaceutical Services to take questions and discuss matters. MAPS President led a team of 10 to the Session. It was a very lively session and many issues were raised and discussed on policy and technical matters. The Session was informative and much was discussed.
Broadly summarizing, although 24 proposal papers were submitted and presented, the main discussions focused on "Medicine Price Control" over and above other issues like the the "Retrospective application of directives by NPRA for product registrations renewal", "Track-and-Trace" 2D barcode as alternative to Hologram, all of which are very relevant to MAPS members. The Ministry noted that this is certainly a good beginning, working together as a team to embrace the calm & stormy challenges of the pharmaceutical and health industries.
We hope to be able to engage our members to share in greater detail what transpired, in due time.
Pharmacy Renaissance Summit - 24 Mar 2019
MAPS was invited to the 'Pharmacy Renaissance Summit', organised by the Malaysian Community Pharmacy Guild (MCPG), on 24th March 2019. The President was invited to be one of the Speakers of the Summit.
Watch the panel session on Medicine Price Control
MAPS 8th AGM - 21 Mar 2019
There were 28 participants from 22 member Companies (representing 78.6% of the total membership) attending the AGM. Members were briefed on the activities and the financials for the Year, 2018. There was also a better clarity and understanding of the challenges and issues that the Association, together with the other stakeholders, will be addressing in the immediate year ahead.
Mechanism of Drug Pricing Engagement session 27 Feb 2019
A session was called involving the 3 industry Associations, MAPS, PhAMA and MOPI together with the Bahagian Perkhidmatan Farmasi on the subject. The event inculuded several activities where paticipants not only heard the proposed mechanism, but views were expressed and shared with all via the 'Gallery Walk' (picture below) session at the end of the meeting.
NPRA-MAPS Dialogue - 16th November 2018
The NPRA met with MAPS for a dialogue regarding issues and challenges, chaired by the new Director of NPRA, Dr Kamaruzaman bin Saleh. Among the topice covered were
- BE comparator unavailable in Malaysia
- BE study report evaluation for registered products
- BE centre accreditation status
- Stability study report for additional primary repacker/additional packer
- Local Zone IVB stability study laboratories
- Zone II stability study results if the Zone IVB study failed
- Restriction of 2 years shelf life of Traditional Medicine/Health Supplements (TMHS) for the stability study conducted outside Malaysia
- Assay requirement for every active ingredient in TMHS
- Zone IVB stability study requirement for TMHS
- API submission implementation on 1 Jan 2020
- Migration history of variation from Quest 2 to Quest 3+
- Data Cleaning in Quest 3+
- New product submission timeline for correspondences
- Auto logout in Quest 3+
- Stability study requirements for inverted and upright conditions
- Compounding products on sale without regiistration
- Product Registration Renewal of Not Commercially Viable Medicines
- Foreign GMP inspection application
The minutes of the dialogue will be sent to all members once confirmed by the participants.
Malaysian Community Pharmacy Business Forum 3.5 10 Nov 2018
A roundtable dialogue was officially conducted by the Malaysian Community Business Forum (MyCPBF), in collaboration with the Pharmacy Board of Malaysia to scrutinize the pharmacy specialization efforts made and its future. Themed 'The Future of Pharmacy Specialization in Primary Healthcare Services and Community Pharmacy', the dialogue discovered the reality, implementation, and conceptualization of pharmacy specialization following the success of MyCPBF 3.0, themed "Be a Part of the Future: Specialisation in Community Pharmacy"- the previous installment of MyCPBF which consolidates pharmacists and public's perceptions towards pharmacy specialization.
Representatives from organisations include Malaysian Pharmaceutical Society (MPS), Academy of Pharmacy Malaysia, Malaysian Community Pharmacy Guild (MCPG), and Malaysian Dietary Supplement Association (MDSA) and MAPS with with Dr Ramli bin Zainal, Senior Director of Pharmaceutical Services Pharmaceutical Services Division. MAPS President was a guest dialog panellist
For more, please visit the post by MyCBPF
MESYUARAT MAJLIS TINDAKAN SARA HIDUP PERINGKAT KLUSTER KESIHATAN
The Cabinet has reactivated this National Cost of Living Action Council (see News). The executive Committee is chaired by the YAB Deputy Prime Minister. The Council has established 6 clusters of priority focus areas, of which one is the Health Cluster.
One of the oservations was the worrying trend of the rakyat resorting to processed foods which are high in fats, salt and sugar, which have effects on the health of the consumers .
The first meeting of the Health Cluster was held on the 7th November, and was jointly chaired by the Secretary General and Director General of Health.
Engagement on Non-Tariff Measurements (NTMs) with Malaysia Productivity Corporation (MPC)
The Malaysia Productivity Blueprint (MPB) is a national strategy to drive productivity growth over the next three years towards 2020. National Productivity Council (NPC) is the steering committee for MPB and its various initiatives and is chaired by the Prime Minister of Malaysia. NPC leads and provides the right direction at the national level. One of the key thrusts of the MPB is to forge a robust ecosystem for businesses in the country. One of the immediate intiatives was to to review non-tariff measures (NTM) and its procedural requirements that impede business growth, including accelerating the improvement of Malaysia’s logistic performance.
NTMs are policy measures, other than ordinary customs tariffs, that can potentially have an economic effect on international trade in goods, changing quantities traded, or prices, or both. NTMs instruments are any permits, licenses and certificates for export and import of goods imposed by the Ministry and relevant government agencies.
A study showed that 70% of all NTMs in Malaysia was under the Ministry of Health, and this was a clear matter of concern. MAPS had a very lively and honest engagement session with the MPC on this subject on the 24th October.
DISCUSSION ON SETTING UP OF TASK FORCE ON PRP GUIDELINES AT TRAINING PREMISES
A meeting was called by Malaysian Pharmaceutical Society to discuss the subject matter with stakeholders at Wisma MPS on 28th August 2018. This meeting was graced by the Director of Lembaga Farmasi, Tn Hj Mohd Yunos bin Shaari with a contigent of LFM staff. Stakeholders included various Council Members of MPS, Welfare commitee of th Young Pharmacist Chapter, University representatives and industry representatives.
Due to the liberalisation of Provisionally Registerd Pharmacist training, some previously unforeseen issues have surfaced. The lively discussion looked at the need for and the actual working of setting up the said task force.
Stakeholders Consultation on the Proposed Revision of General Practitioners' Charges
Christine Yim representing the MAPS Board, attended a town hall session on "Stakeholders Consultation on the Proposed Revision of General Practitioners' Charges", held at the Health Ministry, on 27th August 2018. It was reported that a visit to the doctor at private clinics nationwide could cost a patient at least three times as much next year.The general practitioners' charges of between RM10 and RM35 are to be increased to between RM35 and RM125.
Meeting with Institute for Biotechnology and Medicine Industry 1st Aug 2018
A delegation of 3 from Institute for Biotechnology and Medicine Industry (IBMI) called on MAPS to explore possible partnership. Resulting from the meeting, MAPS members have been invited to visit the 2018 Taiwan Healthcare+ Expo. Further details can be obtained from 2018 Taiwan Healthcare+ Expo. An email to CEO's will ensue
White Paper on SelfCare in Malaysia 13th July 2018
MAPS members were invited to a discussion on the white paper by PhAMA. PhAMA has done a preliminary study to understand behaviors from key stakeholders in understanding SelfCare in Malaysia and are embarking on next step to work on a strategic road map and action which will lead to this White Paper.
MAPS members received a brief report on the study and were invited to be stakeholdes in future endeavours towards SelfCare
MAPS 7th Annual General Meeting 20th March 2018
The 7th AGM was held on 20th March 2018. The Board of Directors for the term 2018 (20th March) – 2021 was also elected. Members present received and approved the Annual Report and Statement of Account, 2017. Issues and challenges affecting the Industry were also discussed. Moving forward, the President urged members to continue to be active as the “strength of MAPS is as strong as the members’ engagement and contribution. Please visit the About MAPS page and scroll down for the latest board members.
Dialogue: 19th March 2018
MAPS President, Mr Lim Teng Chyuan presided in a dialogue on 19th March 2018
Pharmacy Revolution 4.0
On 11th March 2018, the President, Mr Lim Teng Chyuan and the Executive Director, Dr Choe Tong Seng participated in a Seminar with the Theme: Pharmacy Revolution 4.0. It was organised by the Malaysian Community Pharmacy Guild (MCPG). Industry Revolution 4.0 is expected to challenge and disrupt the business model of tradition business and the competitive landscape.
Draft: Code of Ethics for Pharmacists 2018
MAPS, led by the President and four other members, attended the Session on “Draft: Code of Ethics for Pharmacists 2018”, organised by the Lembaga Farmasi, on 2nd March 2018 in the NPRA meeting room. It was a lively discusiion on the contents of the draft. This draft once approved by the Lembaga Farmasi will replace the existing Code of Conduct for Pharmacist.
DUNas 2018 Steering Committee Terms of Reference meeting
The objective of the National Medicines Policy (Dasar Ubat Nasional -DUNas) is to promote equitable access and rational use of safe, effective and affordable essential medicines of good quality
to improve health outcomes of the people. It is a five year policy implementation involving government and private stakeholders aimed at achieving positive outcomes and transformation such as establishing a comprehensive regulation system, strengthening of the laws and regulations, creating a robust pharmaceutical industry as well as developing an extensive pharmaceutical distribution network.
This steering committee is for the monitoring and evaluation of the progress in achieving the initiatives of the framework established in the DUNas Core Action Plans. A meeting for this committee was chaired by the Director General of Health, Malaysia Datuk Dr. Noor Hisham bin Abdullah at Putrajaya on 26th February. The President of MAPS represented the association in this meeting of stakeholders.
The Associated Chinese Chambers of Commerce and Industy Malaysia Chinese New Year Grand Dinner
The Associated Chinese Chambers of Commerce and Industry of Malaysia (ACCCIM) is the national level organisation of the Chinese chambers of commerce in the country. MAPS has had engagements with the organisation on matters of national importance. ACCCIM invited MAPS for its Chinese New Year Grand Dinner Feb 24 2018 at the Setia City Conventon centre, with the YAB Prime Minister as guet of honour.
Workshop: Updates on API, BE and LAB on 18th January 2018
A 1-day Workshop Updates conducted by 6 Regulatory Officials from the NPRA attracted 39 participants from 23 member Companies. This Workshop was very profitable and many had learnt from the knowledge shared and definitely would enhance successful dossiers submission at the first attempt. Congratulations to all participants. Heartfelt thanks to GS Beh, SM Chong and Tammy Lim for successfully organised this Workshop.
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