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Date: 30 March 2010

GMiA 2nd edition Code of Practice out for consultation

Today the Generic Medicines Industry Association (GMiA) applied to the Australian Competition and Consumer Commission (ACCC) for authorisation of the second edition of the GMiA Code of Practice.

The application by GMiA for authorisation by ACCC of its Code of Practice continues to formalise the high standards of behaviour adhered to by members.

The second edition of the Code of Practice strengthens the first edition by providing stakeholders clearer guidance and transparency of Code processes. In particular, enhancements have been made to the Code complaint processes.

Members of GMiA will continue to adhere to the current (first) edition of the GMiA Code of Practice during the six month ACCC authorisation review period.

GMiA welcomes and encourages feedback from stakeholders. Feedback can be submitted to code@gmia.com.au.

Click here to view draft second edition GMiA Code of Practice

Date: March 1, 2010

GMiA self-regulatory Code of Practice adopted 1 March 2010

A new Code of Practice formalising the high standards of behaviour adhered to by members of the Generic Medicines industry Association (GMiA) has been released today.

Based on a series of principles, the GMiA Code of Practice provides guidance to members and the public on the legislation, regulation and guidelines that sponsors of generic medicines comply with.

GMiA members recognise that their promotional and educational activities can affect the way doctors make decisions about treatments and the particular medicines prescribed. Rigorous standards must be applied to the relationship between members and healthcare professionals to ensure that optimal healthcare outcomes are achieved for consumers

The Code provides a framework for appropriate relationships by providing transparency around the provision by members of hospitality and other benefits to prescribers of medicines. Commencing 1 April 2010, each member of GMiA will provide a report to GMiA on all educational events for prescribers held or sponsored by that member that will be posted on the GMiA website.

GMiA seeks to use all reasonable endeavours to provide healthcare professionals and consumers with a quick, effective and cost free method for redress of complaints against a member with regard to breaches of the Code.

Complaints from stakeholders should, in the first instance, be referred back to the respective member who will use all reasonable endeavours to resolve the complaint quickly and effectively. If the stakeholder is not satisfied with the action or decision of the member, the stakeholder may refer the complaint to the GMiA Code Complaint Committee via the GMiA secretariat at code@gmia.com.au.

GMiA welcomes and encourages feedback from stakeholders. Feedback can be submitted to code@gmia.com.au.

GMiA will lodge the application for authorisation of the Code of Practice by ACCC this month.

Click here to view GMiA Code of Practice

Date: September 10, 2009

Members of GMiA adhere to a high standard of ethical practices

GMiA welcomes the Government's review of the marketing obligations of the therapeutic goods industry.

All members of the Generic Medicines Industry Association operate at a high ethical level. Members supply, market and sell medicines in accordance with the requirements of the:

Trade Practice Act (Cth) 1974
National Health Act (Cth) 1953
Therapeutic Goods Act (Cth) 1989 and associated Regulations 1990
Therapeutic Goods Advertising Code 2007; and
all other relevant laws, codes and guidelines.

GMiA looks forward to the TGA industry consultative committee meeting next week to discuss the respective industry Codes of Practices.

GMiA is well advanced in the process of preparing its Code of Practice. The Code of Practice is being developed following the ACCC “Guidelines for developing effective voluntary industry codes of conduct”. GMiA will forward its Code of Practice to ACCC for review.

GMiA is committed to providing a workable, responsible and evolving framework in the development and implementation of its Code of Practice that strongly contributes to good health outcomes.

Date: July 24, 2009

Australian medicines makers will miss share of $150 billion export market

AUSTRALIAN generic medicine manufacturers will miss a share of the $150 billion export market during the next six years, because the Government will not take steps to secure a part of this important export market.

The Government announced yesterday it has obtained advice from the Solicitor-General who has determined that it is not possible to make the amendments proposed by GMiA to open up this export market.

The Government is not prepared to share the contents of the Solicitor-General advice.

It is disappointing for the development of the generic medicines industry in Australia. The Government's decision will have a detrimental impact on growth of member companies in Australia.

Medicines that could be made in Australia, by Australian workers, to generate export dollars for the Australian economy will not be made. These medicines will need to be made offshore.

GMiA maintains that the proposed changes would never have adversely impacted the patent rights of originators. Unfortunately this decision adversely impacts the employment and trade prospects for Australians.

Kate Lynch
Chief Executive Officer

Date: July 7, 2009

Australian medicines makers set to miss share of $150 billion export market

AUSTRALIAN generic medicine manufacturers stand to miss a share of $150 billion export market during the next six years, unless the government steps in quickly.

Australia's implementation of patent extensions is disadvantaging local manufacturing workers, scientists and future research graduates, against virtually every other location in the world, locking them out of export markets and further investment in Australian jobs.

The issue has united support from the National Union of Workers, the Australian Manufacturing Workers Union, the Generic Medicines Industry Association and AusBiotech.

A simple amendment could enable Australian based manufacturers to compete on a level playing field with generic manufacturers elsewhere in the world without disadvantaging patent holders in Australia or anywhere else.

The recommended changes will preserve the rights of patentees in Australia and also allow Australian manufacturing to make medicines for the massive world market.

Typically patent extensions expire later in Australia compared to other jurisdictions. Existing local laws prevent manufacturing in Australia for export until the local patent extension has expired, even if the destination of the product is to overseas markets where the patent has expired and other manufacturers are supplying these markets from other markets.

Member company, Hospira, is just one timely example of an American owned pharmaceutical company wanting to invest in more manufacturing in Australia. One of Hospira's new generic cancer medicines being developed in Australia aims to tap a global market worth more than $1.5 billion today, but unless the modification is made for our industry Hospira will make it elsewhere. And they are just one of many companies making similar decisions regularly.

This proposal does not:

alter the balance between patent owners and generic companies; it eliminates a self-imposed barrier to trade for Australian generic manufacturers against their generic counterparts around the world and is all about growing jobs and exports for Australia.
dramatically weaken intellectual property legislation: it has been carefully crafted to ensure the commercial return to patent holders is preserved in Australia and elsewhere. These products are going to be manufactured somewhere in the world today and marketed everywhere – but Australian manufacturers won't be chosen because the playing field is not level.

The pharmaceutical sector is the second largest export manufacturer in Australia. The generic medicine industry is the fastest growing segment of the industry. With the ability to manufacture for export there is the potential to increase Australia's pharmaceutical exports by 10%, from $3.9 billion today.

Kate Lynch
Chief Executive Officer

Date: 8th May 2009

Study finds generic medicines in Australia cheaper than in the US

A recent study by Deakin University, Victoria, has found prices of generic medicines in Australia are in many instances well below the levels faced by US consumers.

Bulfone (Australian Health Review May 2009 Vol 33 No 2 p200) considered the prices of the most frequently prescribed 52 generic molecules on the Pharmaceutical Benefits Scheme. Of these, 33 molecules were found to be priced at or below the US price.

Many of these molecules are substantially cheaper in Australia than the US. For example salbutamol 100mcg oral pressurised inhaler (200 doses), a commonly used asthma medication is 385% cheaper in Australia; perindopril arginine 2.5mg tablets, a commonly used medication for blood pressure, is 260% cheaper in Australia; ramipril 5mg tablets, another commonly used medication for blood pressure, is 220% cheaper in Australia.

The study found that some items were more expensive in Australia than in the US. This is most likely due to several outdated assumptions used in the study:

Exchange rate: The study did not use good economic practice by adopting a representative exchange rate. It uses an exchange rate of 0.94 as at Aug '08 where a more representative rate closer to 0.7 should have been used.
Medication prices: The study uses Australian prices as at May '08. This was just prior to the Commonwealth Government's mandated price cuts of 25% on many generic medicines in Aug '08. Hence Australian generic medicine prices are already lower than assumed in the study.

The US generic medicines market is one of the most competitive markets in the world. It is a very positive finding for Australian consumers that the prices of Australian generic medicines in many cases are substantially less than US prices.

The Generic Medicines Industry Association supports and encourages debate and dialogue around the important policy area of generic medicines prices.

Kate Lynch
Chief Executive Officer

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