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Thursday, 24 February 2011
Page: 1363


Ms KING (Parliamentary Secretary for Health and Ageing and Parliamentary Secretary for Infrastructure and Transport) (9:39 AM) —I move:

That this bill be now read a second time.

When prescription and other higher risk medicines are approved for marketing in Australia by the Therapeutic Goods Administration, a document known as ‘product information’ is approved for the use of health professionals. This bill amends the Copyright Act 1968 to ensure the long-standing practice of the TGA of approving product information that is in a similar form for all brands of a registered medicine can continue.

These amendments reflect the government’s concern that the important public health objectives of accurate, consistent information for prescribers and consumers might be jeopardised if some pharmaceutical companies claim infringement of copyright in the approved product information of their registered medicines in an attempt to delay market entry of their competitors’ generic versions of those medicines.

While this is only a recently emerging phenomenon, the use of copyright for this purpose has been identified as an issue that needs to be addressed.

Product information contains technical information about the medicine such as the characteristics of the active ingredient, its indications and contraindications, a description of clinical trials that support the indications, precautions, possible adverse reactions, dosages and storage, and other information relating to the medicine’s safe and effective use. Its purpose is to assist medical practitioners, pharmacists and other health professionals to prescribe or dispense the medicine appropriately and safely, and to assist them to provide patient education about the medicine in support of high quality and safe clinical care.

It is critical that doctors and pharmacists receive the same information when prescribing and dispensing all brands of the same medicine. It is, therefore, the Therapeutic Goods Administration’s practice to approve a text for the product information of a generic medicine that is in a similar form to that approved for the product information of the original medicine. This avoids any perception that differences in the text of the approved product information for the different brands of a medicine reflect clinical or pharmacological variations in the medicine itself.

Brand substitution policy was introduced in Australia in 1994 to encourage the use of generic medicines. The policy makes it possible to substitute, where appropriate, the prescribed drug brand at the time of dispensing in the pharmacy. This practice is a vital component of pharmaceutical policy in Australia as it contributes directly to improved access and affordability of pharmaceuticals to both the government and health consumers. Timely availability of generic medicines is an essential feature of this policy.

Any barriers that have the effect of preventing or delaying market entry of new brands of medicines will have significant financial implications for both government and consumers by reducing the effectiveness of the further reforms to the Pharmaceutical Benefits Scheme implemented under the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2010. Members will be aware that under these reforms the first listing of a generic version of a medicine now triggers a 16 per cent reduction in the price the Commonwealth pays for the medicine. The reforms will provide an estimated $1.9 billion in savings to government and an average savings over 10 years to consumers of $3 per general PBS prescription. These savings will contribute to the sustainability of the scheme and maintain access to quality medicines at a lower cost to the taxpayer.

Action by pharmaceutical companies based on a claim of copyright in product information can substantially delay savings to the government and Australian consumers because the price reduction trigger of the first listing of a generic version of a listed medicine on the PBS is absent. It can also artificially prolong any market exclusivity that the company may have had under patent law.

Recently a number of pharmaceutical companies have taken, or threatened to take, legal action alleging that the use by another company of product information approved by the TGA for a generic version of a medicine is an infringement of copyright. In 2008 an interlocutory injunction was granted by the Federal Court to a pharmaceutical company sponsor of a registered medicine partly on the basis of an argument that copyright in the approved product information for that medicine would be infringed by a competitor’s use of the approved product information for a generic version. The Federal Court hearing on this matter, scheduled for early March 2011, will consider the issue of copyright in the approved product information of a registered medicine. This consideration will be the first time by an Australian court.

In December 2010, in an apparent attempt to avoid the risk of similar litigation, the first generic version of a medicine was marketed without its approved product information being made available. While this is not in breach of any existing requirements under the Therapeutic Goods Act, it is not conducive to the quality use of medicines and is not a desirable outcome for public health. If the marketing of this medicine had been prevented by an injunction, the PBS statutory price reduction would not have been triggered.

Pharmaceutical companies currently receive appropriate patent protection for their medicines under Australian law. Apart from the market exclusivity conferred under the Patents Act, the Therapeutic Goods Act includes measures that require a person applying to register a generic medicine to certify either that they believe on reasonable grounds that a patent will not be infringed by the marketing of the medicine, or that the relevant patent holder has been notified of the application. Data protection provisions also prevent information provided to the Therapeutic Goods Administration in relation to a medicine containing a new chemical entity from being used to evaluate a generic product for a period of five years from the day on which that medicine was registered. The government believes these measures safeguard a fair return for the efforts of companies bringing medicines to market. The use of copyright injunctions to prevent generic medicines being marketed has the potential to provide the patent owners with a substantial additional period of market exclusivity after the patent has expired as copyright has a duration of at least 70 years from publication.

This issue is not unique to Australia. Similar issues have arisen in the United States in relation to federal drug administration’s ‘same-labelling’ requirements for medicines under the Hatch-Waxman amendments to the Federal Food, Drug and Cosmetic Act. These amendments were designed to facilitate the introduction of generic competitors once the originator’s drug patent term and exclusivity periods ended by allowing the generic producers to ‘piggyback’ upon the originator’s successful FDA application. The same labelling requirement was upheld by the Second Circuit, United States Court of Appeal in 2000 in the SmithKline Beecham consumer healthcare case in which the court commented that the purpose of the Hatch-Waxman amendments would be severely undermined if copyright concerns were to shape the FDA’s application of the requirements. The court found as a consequence that the same-labelling requirements prevailed over copyright laws.

I now turn briefly to the amendments themselves.

The bill will insert a new section 44BA into the Copyright Act 1968. The effect will be that actions under the Therapeutic Goods Act for the purposes of approving product information for prescription and other higher risk medicines, or of approving variations to approved product information will not be an infringement of copyright subsisting in any product information previously approved by the Therapeutic Goods Administration. This will ensure, for instance, that an applicant for the registration of a generic version of a registered medicine will not infringe copyright if it provides a draft product information document that contains text similar to the product information already approved for that medicine. This exemption would apply irrespective of when the product information was approved, that is, whether it was approved before or after the amendments come into effect.

Secondly, the supply, reproduction, publication, communication or adaptation of any approved product information of a registered medicine will not be an infringement of copyright in any other approved product information where such an act is done for a purpose related to the safe and effective use of the medicine concerned. This exemption would apply to such acts irrespective of when the product information was approved. It would cover, for instance, acts of the Commonwealth (including by the Therapeutic Goods Administration), pharmaceutical companies and healthcare professionals and all those involved in making product information available to health professionals.

The infringement exemption will only apply to acts done after the commencement of the amendments.

The bill includes a so-called ‘historic shipwrecks clause’ which ensures that if the amendments would result in the acquisition of property from a person otherwise than on ‘just terms’, the Commonwealth must pay ‘reasonable compensation’ to that person. This provision has been included as a precautionary measure to ensure constitutional validity and does not indicate that such a result is likely.

Exempting particular acts from infringement action under the Copyright Act is not done lightly. The proposed amendments reflect the importance the government places on ensuring the highest levels of health consumer safety through the provision of accurate information to prescribers and other health professionals about higher risk medicines. The only other exemption of this kind in the Copyright Act relates to the use of approved labels on containers for agricultural and veterinary chemical products.

The amendments go no further than is necessary to ensure that the TGA can continue to approve product information that is in a similar form for all versions of the same registered medicine.

The government believes that these amendments will restore the appropriate balance between ensuring safe and timely access to medicines for all Australians and encouraging research and development in the pharmaceutical industry through appropriate protection of intellectual property.

I commend the bill to the House.

Debate (on motion by Mr Pyne) adjourned.