The document provides a detailed summary of amendments included in Edition 18 of the Medicines Australia Code of Conduct. Key changes include: capping the maximum cost of meals provided to healthcare professionals at $120; requiring transparency reporting of payments/transfers of value to individual HCPs; and clarifying rules around the provision of information on unapproved products/indications and disease education activities. Administrative changes were also made to committees established under the Code and various definitions in the Glossary.
UCPMP guidelines pharma marketing code by http://www.dailyrounds.org/blog/ucp...Siddhartha Dash
Uniform code for pharmaceutical marketing Practices UCPMP Guidelines, Codes and Impact on Industry by DailyRounds.org (Largest network of doctors 200000+ & counting).
http://www.dailyrounds.org/blog/ucpmp-uniform-code-of-pharmaceuticals-marketing/
New Indian pharma policy and its impact on Pharmaceutical Industry, Benefits to people, Impact on Imports, employment, skill development, marketing practices and impact of policy in ease of doing business.
UCPMP guidelines pharma marketing code by http://www.dailyrounds.org/blog/ucp...Siddhartha Dash
Uniform code for pharmaceutical marketing Practices UCPMP Guidelines, Codes and Impact on Industry by DailyRounds.org (Largest network of doctors 200000+ & counting).
http://www.dailyrounds.org/blog/ucpmp-uniform-code-of-pharmaceuticals-marketing/
New Indian pharma policy and its impact on Pharmaceutical Industry, Benefits to people, Impact on Imports, employment, skill development, marketing practices and impact of policy in ease of doing business.
Piacenza, October 14, 2011
"Innovating Food, Innovating the Law"
Conference
Iacopo Berti (Autorità Garante della Concorrenza del Mercato, Italy)
Informing or advertising? The blurring boundaries
video: http://vimeo.com/31026695
Financing Options for Antiretroviral ProcurementHFG Project
This presentation contains proposals to local partners to present policy options for centralized reimbursement and co-payment. In this way, HFG provides much needed technical support to the Ministry of Health and other government agencies in Vietnam. Furthermore, this proposal illustrates the means by which HFG, through the Sustainable Finance Initiative (SFI), is facilitating domestic revenue generation and strengthening public financial management in support of HIV/AIDS treatment and care.
As FDA begins to restart on-site inspections of domestic and foreign sites, Health Canada on the other hand has all of its on-site domestic and foreign inspections for drug good manufacturing practices postponed until further notice...
Regulatory requirements for drug approval in Saudi ArabiaSridhar S
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
Sanitizer & Disinfectants During COVID 19 – A Brief StudyJohn William
In the ongoing pandemic, the demand for disinfectants and sanitizers has grown manifold. To meet the increasing requirements, the WHO has recommended two formulations based on 75% Isopropyl alcohol and 80% Ethanol separately for local manufacturing. Know more here!
Sfee press release_disclosure_code_20141009_2Market iT
EFPIA Member Association SFEE (The Hellenic Association of Pharmaceutical Companies) last week introduced a new code of industry self-regulation, in line with the EFPIA Disclosure Code
MTBiz is for you if you are looking for contemporary information on business, economy and especially on banking industry of Bangladesh. You would also find periodical information on Global Economy and Commodity Markets.
Piacenza, October 14, 2011
"Innovating Food, Innovating the Law"
Conference
Iacopo Berti (Autorità Garante della Concorrenza del Mercato, Italy)
Informing or advertising? The blurring boundaries
video: http://vimeo.com/31026695
Financing Options for Antiretroviral ProcurementHFG Project
This presentation contains proposals to local partners to present policy options for centralized reimbursement and co-payment. In this way, HFG provides much needed technical support to the Ministry of Health and other government agencies in Vietnam. Furthermore, this proposal illustrates the means by which HFG, through the Sustainable Finance Initiative (SFI), is facilitating domestic revenue generation and strengthening public financial management in support of HIV/AIDS treatment and care.
As FDA begins to restart on-site inspections of domestic and foreign sites, Health Canada on the other hand has all of its on-site domestic and foreign inspections for drug good manufacturing practices postponed until further notice...
Regulatory requirements for drug approval in Saudi ArabiaSridhar S
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
Sanitizer & Disinfectants During COVID 19 – A Brief StudyJohn William
In the ongoing pandemic, the demand for disinfectants and sanitizers has grown manifold. To meet the increasing requirements, the WHO has recommended two formulations based on 75% Isopropyl alcohol and 80% Ethanol separately for local manufacturing. Know more here!
Sfee press release_disclosure_code_20141009_2Market iT
EFPIA Member Association SFEE (The Hellenic Association of Pharmaceutical Companies) last week introduced a new code of industry self-regulation, in line with the EFPIA Disclosure Code
MTBiz is for you if you are looking for contemporary information on business, economy and especially on banking industry of Bangladesh. You would also find periodical information on Global Economy and Commodity Markets.
MTBiz is for you if you are looking for contemporary information on business, economy and especially on banking industry of Bangladesh. You would also find periodical information on Global Economy and Commodity Markets.
Case 13340B Drug Pricing Program OversightSection 602 of the Vet.docxketurahhazelhurst
Case 13340B Drug Pricing Program Oversight
Section 602 of the Veterans Health Care Act of 1992 was titled “Limitations on Prices of Drugs Purchased by Certain Clinics and Hospitals.”It amended the Public Health Services Act by adding a new section, Section 340B, to that act. Section 602 of the Veterans Health Care Actread in part:
Part D of title III of the Public Health Service Act is amended by adding the following subpart: “SUBPART VII – DRUG PRICINGAGREEMENTS” LIMITATION ON PRICES OF DRUGS PURHASED BY COVERED ENTITIES “Sec. 340B (a) Requirements for Agreement withSecretary – “(1) In general. The Secretary shall enter into an agreement with each manufacturer of covered drugs under which theamount required to be paid … to the manufacturer for covered drugs … does not exceed an amount equal to the average manufacturerprice for the drug under title XIX of the Social Security Act in the preceding quarter, reduced by the rebate percentage described inparagraph (2). “Rebate percentage defined. – (A) In general. For a covered outpatient drug … the ‘rebate percentage’ is the amount equalto – “(i) the average total rebate required under Section 1927(c) of the Social Security Act … for a unit of the dosage form and strengthinvolved during the preceding quarter divided by “(ii) the average manufacturer price for such a unit of the drug during such quarter….”
Section 340B applied Medicaid drug discounts to drugs purchased for clinics that served many outpatients who were not eligible forMedicaid at qualified safety-net institutions. For the most part, eligible clinics were associated with hospitals receiving disproportionateshare payments under Medicare, pediatric hospitals, and community health centers. Also included were specialized clinics and projects forHIV/AIDS, hemophilia, black lung, tuberculosis, and family planning, as well as those serving Native Americans and Native Hawaiians.Hospitals were required to be governmental or nonprofit with a contractual commitment to provide services supported by governments,have a disproportionate share percentage greater than 11.75, and not obtain the covered drugs through a group purchasing agreement. Thedrugs had to be used for patients of the covered entity and could not be resold.
A key provision of Section 340B read “(10) No prohibition on larger discount. Nothing in this subsection shall prohibit a manufacturer fromcharging a price for a drug that is lower than the maximum price that may be charged under paragraph (1).” The Patient Protection andAffordable Care Act (ACA or PPACA) increased the 340B discount to 13% on generic drugs and 23.1% on branded drugs. Specific discountshave been reported to range from 15–60% on prescription drugs. The law prohibits getting both a state Medicaid rebate and a 340Bdiscount on a drug.
BACKGROUND
In the 1980s, Congress established a discount drug purchasing program for the Veterans Administration. In 1990, it extended this discountprogram to Medicaid purchases on beh ...
HIGHLIGHTED: Dissemination of Patient-Specific Information from Devices by De...NextWorks
This is the highlighted version of FDA's Guidance for Industry: Dissemination of Patient-Specific Information from Devices by Device Manufacturers from June 2016.
When these guidances come out, I typically go through them and highlight the most relevant portions for those who need to skim through or refresh their memory.
Regulatory updates from the TGA Medical Devices Branch - Part 2TGA Australia
Presentation on the regulation of software including software as a medical device, proposed regulatory scheme for personalised medical devices, including 3D Printed Devices, proposed changes to the Essential Principles, Conformity Assessment Procedures, and the requirements for devices used in clinical trials, and clarifying the requirements for systems and procedure packs
October 24, 2011 CMS published changes to many of the hospital Conditions of Participation (CoP) requirements. In March 2012, CMs provided an “Advanced Copy” in a Transmittal of the new Appendix A. Although no changes were made to the CMS CoP under “Patient Rights-Advance Directives” §489.102, significant changes were made to the “Interpretive Guidelines” and “Survey Procedures.” CMS took the opportunity to expand patient’s rights related to advance directives, (AD). The focus of the changes to advance directives centered on the incapacitated patient and the designation of a representative for decisions related to healthcare matters. The Interpretive Guidelines indicate that the decision maker need not be the same person as the designated representative. Additionally, if the patient does not have an AD designating a “representative for decision making,” the hospital follows state rules for designation of a decision maker, i.e. spouse, parents, children, siblings, etc.
- This Circular provides for the activities relating to production, trading, product declaration, labeling and provision of instructions for use of functional foods such as
supplemented foods, health supplements and medical foods, including foods for special dietary uses.
- This Circular does not apply to nutritional formulas for children. Production, trading,
product declaration, labeling and provision of instructions for use of these products shall
comply with corresponding technical regulations and regulations of law on trading and use of nutritional products for children
Key additions and amendments introduced under the CPRAVISTA InfoSec
On November 3rd, 2020, the California Privacy Right Act was passed as the latest version of the California Consumer Privacy Act which recently came into effect on the 1st of July, 2020. CPRA brings significant amendments and additions to the rules of Data Privacy outlined in the CCPA Compliance. Declaring its enforcement in 2023, the CPRA introduced some new concepts to Data Privacy in California. With new additions and amendments, the CPRA bridges certain potential loopholes in the previous version of CCPA, making the law stringent. Further, introducing the amendments and new additions to the provision has taken this Data Privacy law closer to the EU’s GDPR standard. Let us today through this article take a look at the new provisions introduced and understand the amendments in the Data Privacy Standard.
ABBREVIATED NEW DRUG APPLICATION (ANDA),INVESTICATION OF MEDICINAL PRODUCTS D...GOKULAKRISHNAN S
Introduction to ANDA
Regulations applied to ANDA process
Format and content of ANDA
ANDA approval process
Exclusivity
Hatch-Waxman amendments & 180 days exclusivity
Introduction to IMPD
Contents of IMPD
Introduction to IB
Contents of IB
The Center for Medicare and Medicaid Innovation released a Request for Information (RFI) in late 2013 entitled the “Evolution of ACO Initiatives at CMS.” These are the first of two batches of responses received by the Center for Medicare and Medicaid Innovation to the RFI.
- - -
CMS Innovation Center
http://innovation.cms.gov
We accept comments in the spirit of our comment policy:
http://newmedia.hhs.gov/standards/comment_policy.html
CMS Privacy Policy
http://cms.gov/About-CMS/Agency-Information/Aboutwebsite/Privacy-Policy.html
News Flash – On June 18, 2010, the Office of the National Co.docxhenrymartin15260
News Flash – On June 18, 2010, the Office of the National Coordinator for Health Information
Technology (ONC) issued a final rule to establish a temporary certification program for electronic health
record (EHR) technology. To see the press release related to this rule, visit
http://www.hhs.gov/news/press/2010pres/06/20100618d.html on the Internet.
MLN Matters® Number: SE1022 Related Change Request (CR) #: N/A
Related CR Release Date: N/A Effective Date: N/A
Related CR Transmittal #: N/A Implementation Date: N/A
Medical Record Retention and Media Formats for Medical Records
Provider Types Affected
This is an informational article for physicians, non-physician practitioners,
suppliers, and providers submitting claims to Medicare contractors (carriers, fiscal
intermediaries (FIs), and Medicare Administrative Contractors (MAC)) for services
provided to Medicare beneficiaries.
Provider Action Needed
STOP – Impact to You
This Special Edition is informational in nature. There are no additions or changes
to current policies and procedures.
CAUTION – What You Need to Know
This article provides guidance for physicians, suppliers, and providers on record
retention timeframes.
GO – What You Need to Do
Review the information in this article and ensure that you are in compliance. Be
sure to inform your staff.
Disclaimer
This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to statutes, regulations, or other
policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to
review the specific statutes, regulations and other interpretive materials for a full and accurate statement of their contents.
Page 1 of 3
http://www.hhs.gov/news/press/2010pres/06/20100618d.html
MLN Matters® Number: SE1022 Related Change Request Number: N/A
Disclaimer
This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to
statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either
the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statement
of their contents.
Page 2 of 3
Retention Periods
State laws generally govern how long medical records are to be retained.
However, the Health Insurance Portability and Accountability Act (HIPAA) of 1996
(HIPAA) administrative simplification rules require a covered entity, such as a
physician billing Medicare, to retain required documentation for six years from
the date of its creation or the date when it last was in effect, whichever is
later. HIPAA requ.
Similar to The Medicines Australia Code of Conduct : Summary of the changes included in Edition 18 (20)
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
The Medicines Australia Code of Conduct : Summary of the changes included in Edition 18
1. Detailed Summary of Amendments included in Code of Conduct Edition 18 1
Detailed Summary of Amendments
Included in Code of Conduct Edition 18
The following summarises the amendments included in Edition 18 of the Code.
All references to other publications, such as TGA guidelines, have been updated.
Introduction
Inclusion of proactive statement about commitment to transparency and how the
industry interacts with healthcare professionals.
Amendment of description of the relationship between the Code and Medicines
Australia’s Constitution.
1. Nature and Availability of Information and Claims
1.1 Responsibility
Additional information on achieving balance by inclusion of safety and precautionary
information in relation to efficacy or other promotional claims.
1.4 Unapproved Products and Indications
Inclusion of a mechanism to permit companies to make information available about
unapproved products and/or indications via a medical information website. This
website may not be promoted to HCPs. It cannot include advertising or promotional
information.
1.7 New Products
Clarification that promotion that a product will be available via the PBS, RPBS, NIP or
LSDP may only occur after written advice is received from the Department of Health
stating the listing date.
2. Promotional material directed at healthcare professionals
Primarily editorial changes.
2.2 Electronic and Audiovisual Media including electronic Detail Aids (e-Detail Aids)
A new requirement that text that is given prominence in printed forms of promotional
materials, such as PBS information, qualifying statements and referring the prescriber
to review the Product Information, should be similarly prominent by text size and
location in electronic and audio-visual media.
2.4.1 Advertisements for healthcare professionals on Company controlled websites and in
independent e-journals and e-Newsletters
Equivalent requirement to that made in Section 2.2 (above) relating to prominence of
text in electronic forms of advertisements.
3. Types of Product Information
3.2 Minimum Product Information
A new explicit requirement, reflecting current practice, that the Minimum Product
Information must be reviewed and, where necessary, updated in a timely manner
following a change to the Product Information.
2. Detailed Summary of Amendments included in Code of Conduct Edition 18 2
3.3 Changes of clinical significance
Removal of the requirements for the manner in which a change of clinical significance
is communicated to HCPs
Addition of a requirement, consistent with TGA requirements, that companies must
communicate a change to the Product Information in accordance with any direction
from the TGA.
4. Educational Material directed at Healthcare Professionals
Editorial changes only proposed.
5. Company Representatives - Roles and ethical conduct
No changes proposed
6. Company Representatives - Training
No changes proposed.
7. Product Starter Packs
Editorial amendments to ensure the Code is consistent with State and Territory
requirements for distribution of starter packs, including retention of records for supply of
starter packs for a minimum of 2 years unless a longer period is required by State or
Territory legislation.
Section 7.8 – addition of requirement that the Company should supply pre-printed
adhesive labels that comply with the Standard for the Uniform Scheduling of Medicines
and Poisons, Appendix L, and which provide sufficient space for the relevant details to
be entered by the dispensing healthcare professional.
8. Product Familiarisation Programs (PFP)
Addition of a requirement for the patient information document (a current requirement
of the Code) to include a section for the patient to sign indicating their consent to
receive the product under the terms described in the patient information document.
This consent is to be retained by the healthcare professional and is not to be returned
to the company.
New provision to allow trade packs to be supplied for patients enrolled in a PFP if the
product is dispensed through a pharmacy or other authorised dispensary or dispenser.
New provision to allow the collection of individual patient data under a PFP IF the PFP
is set up in a manner that enables the rigorous collection of individual patient data
under a formal protocol. The protocol should be reviewed within the company to ensure
that patient data collection complies with all relevant guidelines and legislation,
particularly with respect to patient consent and data de-identification.
Addition of a requirement, consistent with current practice, that on request, companies
must promptly accept the return of their products supplied under a PFP. Returned
stock must be disposed of in an environmentally sound manner according to the
requirements in each State or Territory.
9. Relationship with healthcare professionals
9.3 – Educational Events
A new requirement that Companies must have policies and procedures in place that
will ensure that educational events for healthcare professionals comply with the Code,
and in particular, the maximum cost of a meal stated in Section 9.4.3.
3. Detailed Summary of Amendments included in Code of Conduct Edition 18 3
9.4.3 Meals and beverages & 9.7.7 Sponsorship of Healthcare professionals to attend
Educaitonal Events (Australasian and International)
Inclusion of a maximum limit of $120 (excluding GST and gratuities) for the cost of a
meal (including beverages) provided by a company to a healthcare professional
within Australia. This maximum would only be appropriate in exceptional
circumstances, such as a dinner at a learned society conference with substantial
educational content. In the majority of circumstances, the cost of a meal (including
beverages) should be well below this figure. For hospitality in association with
overseas educational meetings this maximum and/or local guidelines should be
used as a guide.
9.4.4 Travel & 9.7.5 Sponsorship to attend an Educational Event (equivalent provisions)
New requirement that travel to attend a company organised educational meeting, or
to attend an international, third party educational meeting, may only be provided in
direct association with the educational event/s. Any air travel provided must be by
the most practical direct route to and from the educational event/s.
9.6 – Trade Displays
New requirement that the amount paid to the educational meeting organiser for a
trade display is regarded as sponsorship and must be reported in the current
educational event reports (until 30 September 2015) (section 41.2.2) and then from
1 October 2015, in the new Sponsorship of Independent Educational Meetings
report(section 41.3.5).
9.10 - Reporting Payments to Healthcare Professional Consultants and Advisory Board
Members
Section deleted – all reporting requirements moved to Section 41.
11. Ghost writing
Definition of ghost writing amended to recognise that professional medical writers, who
disclose their involvement in writing and their funding source, are acceptable, whereas
ghost writers are not acceptable.
12. Market research with HCPs
Deletion of sections relating to reporting payments, which are now included in Section
41.
13. Relationship with the general public
13.1 General Principles
New requirement for materials for members of the general public are consistent with
Section 1.3 of the Code: all information, claims and graphical representations provided
to members of the general public must be current, accurate, balanced and must not
mislead either directly, by implication, or by omission. All statistics or analyses
provided to the general public by companies must be referenced to their source.
13.7 Materials for use with patients (Patient aids)
Moved from position as Section 17, and a definition included. Patient aids specifically
includes mobile media applications.
4. Detailed Summary of Amendments included in Code of Conduct Edition 18 4
13.8 Disease Education Activities in Any Media
Addition of clarifying statement that the linking of a disease education activity to a
specific prescription product, such as linking to the Product Information or Consumer
Medicine Information, would breach Section 13.3 of the Code and the Commonwealth
Therapeutic Goods legislation.
13.9 Use of the Internet
Revision of the definition of ‘advertisement’ to ensure consistency with the Therapeutic
Goods Act 1989.
Addition of text from the Code Guidelines to make it clear that a company website must
not directly link disease specific education to the company’s prescription products for
that condition. Such linkage would be considered to be advertising the prescription
medicine, which would be in breach of Section 13.3 of the Code and the Therapeutic
Goods legislation.
Inclusion from the Code Guidelines that a company disease education website must
use a product name for its URL.
13.11 Market research with the general public
Inclusion of recognition that market research undertaken with patients who have been
prescribed a particular prescription medicine may include specific questions about the
product as long as the market research is not promotional.
14. Relationship with HCOs and patients
Deletion from this section of the requirement for disclosure of HCO support, which is
now included in Section 41.
15. Sponsorship of Individual Patients/HCO Representatives to Attend Third Party
Educational Events
No changes
16. Access to Company Trade Displays at Third Party Conferences
No changes
17. Patient Support Programs
Addition of explicit requirement, consistent with current practice and TGA requirements,
that suspected Adverse Drug Reactions noted during monitoring of a Patient Support
Program must be reported to the TGA in accordance with the relevant guidelines.
18. Access to Dispensary Data & 19. Discredit to and Reduction of Confidence in the
Industry
No changes
20 – 24 Administration of the Code
This section of the Code has been extensively revised in order to clarify and make
explicit the relationship between the Code of Conduct and the Medicines Australia
Constitution; and the Medicines Australia Board and the three Committees established
under the Code – the Code of Conduct Committee, Appeals Committee and Monitoring
Committee.
5. Detailed Summary of Amendments included in Code of Conduct Edition 18 5
20.1 Acceptance of Complaints
Inclusion of a discretion to either not accept a complaint, or accept a complaint and
defer referral to the Code Committee where substantially the same subject matter
is, at the same time, the subject of legal proceedings between the same parties in
an Australian court or Administrative Tribunal.
Sections 21 to 24 – Membership of the Code of Conduct and Appeals Committees &
Sections 32 to 34 Membership of the Monitoring Committee
These sections describing the membership of the Code of Conduct, Appeals and
Monitoring Committees have been revised, in consultation with Medicines
Australia’s legal counsel, to improve their clarity and robustness.
The only change to the membership of the Committees is the addition of a senior
compliance officer as one of the member company representatives that may
participate on either Committee.
31.2 – Monitoring procedures
Clarification of the different types of reviews undertaken by the Monitoring
Committee.
Modification of the number of reviews that a company must respond to in a calendar
year: A Member Company will only be required to provide promotional materials or
information associated with other activities for review by the Monitoring Committee
on no more than three occasions within a calendar year. If a Member Company
responds to a Monitoring Committee request that it had not distributed any
promotional materials or undertaken any activities that are specified in the request,
this response will not be counted as one of the three occasions for that company.
A Member Company will nevertheless be required to respond to a request from the
Monitoring Committee for further information concerning a particular educational
meeting, Advisory Board meeting, Health Consumer Organisation support or
consultancy arrangement.
37.4 Educational Event reporting
Section deleted – all transparency reporting requirements have been moved to
Section 41.
41. Transparency Reporting
All transparency reporting requirements now included under this Section.
The introduction provides an affirmative statement about transparency.
The sections preserve the reporting requirements of Edition 17 of the Code until
30 September 2015.
From 1 October the new requirements for reporting transfers of value to individual
healthcare professionals come into effect, as follows:
The following activities would be reported by companies for individual healthcare
professionals, by name, with the amount of the payment or transfer of value:
Consulting fees and/or speaking fees.
Sponsorship of a healthcare professional to attend an educational event: airfares,
accommodation and/or registration fees (whether held within or outside Australia).
Fees paid to healthcare professional consultants in Australia, or to their employers
on their behalf, for specific services rendered by them: consulting fees,
accommodation and airfares (whether within or outside Australia).
6. Detailed Summary of Amendments included in Code of Conduct Edition 18 6
Fees paid to healthcare professionals in their role as Advisory Board members:
sitting fees, accommodation and airfares (whether within or outside Australia).
Fees paid to healthcare professionals for the purpose of market research ONLY
where the identity of the healthcare professional is known to the company.
Payment of an educational grant or sponsorship to a specific healthcare
professional
The following would not be required to be reported:
Hospitality (food and beverages): The cost of any meal (including drinks) provided
by a company must be below the defined limit set in the Code ($120 for food and
beverages, exclusive of GST)
Airport ground transfers, taxis, parking fees
Venue costs (e.g. room and/or audio-visual equipment hire)
Companies will be required to report transfers of value in accordance with the template
provided in the Code of Conduct Guidelines for Edition 18. Reporting of all individual
transfers of value for each healthcare professional is required, indicating the following
information:
o date of the event or provision of service;
o healthcare professional’s name,
o type of healthcare professional (i.e. medical practitioner, pharmacist, nurse
practitioner)
o healthcare professional’s principal practice address.
o description of the service (i.e. speaker, Advisory Board member, Chairperson
at educational meeting etc)
o description of the event (i.e. company sponsored meeting in Australia;
independent meeting held in Australia; independent meeting held overseas;
etc)
o whether the payment was made to the healthcare professional or a third
party
o the amount of the payment or transfer of value, subdivided into (where
relevant) registration fees, travel and accommodation, and fees for service.
If a healthcare professional does not agree to the information being disclosed with
their name, the expenditure will be reported in aggregate with the number of
healthcare professionals it relates to.
Companies will provide healthcare professionals for whom they have collected
information about payments and transfers of value the opportunity to review and
submit corrections to the information. The period provided for review and
verification or correction must be at least six weeks
The reporting cycle is a six monthly cycle, except for the initial report, which would
cover seven months from 1 October 2015 to 30 April 2016.
The report must be published within 4 months following the end of each reporting
period.
Companies must publish the data about payments and transfers of value on
companies’ own websites. Medicines Australia will provide hyperlinks from its
website to each Member company’s report.
7. Detailed Summary of Amendments included in Code of Conduct Edition 18 7
41.3.5 - Reporting of Sponsorship of Third Party Educational Meetings and Symposia
This new report will provide a report of sponsorships of third party educational
meetings, where a company has provided monetary sponsorship of a meeting
The report will include purchase of space to provide a trade display at an
educational event (including if this is the only sponsorship of the event).
If a company only directly provides hospitality (food and beverages) for an
educational meeting, that is the company brings in sandwiches and drinks or similar
modest hospitality, this is not reportable.
Appendix 1 Guidelines for Complaints – Non-industry Generated Complaints
The Secretariat will (always) offer the service of an Independent Facilitator to a non-
industry complainant.
If the offer of an Independent Facilitator is declined the Secretariat will have the
discretion to refer the complaint to the Monitoring Committee (permanent members)
and request the Committee to advise whether all relevant Sections of the Code
have been identified in the complaint. The Monitoring Committee will only identify
additional Sections of the Code if there is an obvious omission by the Complainant.
Appendix 2 Medicines Australia Constitution
Changes included to ensure consistency with the revised Medicines Australia
Constitution.
Appendix 6 Health Consumer Organisation Support Report Format
Inclusion of the HCO Support template as an Appendix
Glossary
Addition of a definition of ‘adverse effect’, consistent with relevant TGA guidelines
Addition of a definition of an ‘advisory board’
Deletion of definition of ‘clinical tool’ (no longer mentioned in the Code)
Addition of a definition of ‘clinical research’
Addition of a definition of a ‘consultant’
Revision of the definition of ‘a healthcare professional’, by reference to HCPs being
registered to practice in Australia
Addition of a definition of a ‘medical information website’, in relation to the additions to
section 1.4 of the Code
Addition of a definition of ‘transfer of value’.