Introduction
In recent years, approximately 30 Internet Pharmacies have been set up in New Zealand. Some of those are taking advantage of a loophole in s 33 Medicines Act 1981, which allows any person to export prescription medicines for the purposes of sale without requiring a prescription from the buyer. The Ministry of Health is intending to have s 33 amended to eliminate this loophole.

This article will discuss the effect of the Internet on medical practices, the effect of s 33 Medicines Act and of the proposed amendments to s 33.
The Internet is playing an increasingly important role in medical practice. At present, the Internet is used for:
- Obtaining and distributing medical information;
- Establishing global communication between health professionals and patients to discuss illnesses, diseases, and available treatments;
- Diagnosing and treating patients around the world, sometimes without the patient ever being physically examined by a doctor; and
- Obtaining and distributing medicines around the world.
These uses are creating both benefits and problems for the world of medicine.

Medical Information Over the Internet
Although the global exchange of medical information over the Internet is a positive development for medicine, the Internet does not have a system in place to warn or protect Internet users of poor quality or misleading medical information that is not from a credible source. This raises concerns for patient safety.

A benefit of the Internet is that it allows health professionals to stay in close contact with their existing patients. For example, if a patient is travelling and needs to be notified of results, the Internet can be an invaluable tool. However, this type of activity does raise concerns regarding security and confidentiality. Health professionals must secure their terminals and be aware of who has access to a patient's computer terminal before sending information. Sensitive information should not be sent over the Internet without specific permission from the patient concerned.

Medical Advice Over the Internet
The ability of doctors to diagnose patients anywhere in the world over the Internet, without physically examining the patient, does raise concerns regarding patient safety and standards of practice. However, diagnosis or treatment without a physical examination is not a new concept. Doctors often treat patients over the phone, especially in emergency situations. The key is to ensure that doctors meet accepted standards of practice when undertaking such activities. The Medical Council of New Zealand and the Ministry of Health have suggested the following minimum standards for Internet consultations:
- The patient is an established patient of the doctor and they have met at least once;
- The patient and doctor both live within the licensure jurisdiction of the doctor;
- The doctor is confident a physical examination would not add useful information and is prepared to defend that position, with evidence, in the event of a subsequent complaint;
- The charges are appropriate for the time taken for the electronic consultation and are in keeping with normal charging prices; and
- The doctors do not supply medication themselves and are not in special arrangements with suppliers of medication or laboratory services.

A flow-on effect from medical information being available over the Internet is that many patients will be more informed on medical matters concerning them. However, there is the risk of patients being misinformed. Doctors need to be aware of the increased exposure of their patients to medical information that may not be correct, and must be ready to cope with patients who are not willing to accept a doctor's opinion because of the information they have obtained.

Sale of Medical Products Over the Internet
The sale, promotion, and advertising of medical products over the Internet are raising concerns for patient safety, licensure, and health economics. Medical products sold over the Internet can be fraudulent, unapproved, unsafe, and ineffective with misleading product information, and it is possible for patients to obtain these products without any individual counselling from a qualified doctor. It is also a concern that it can be very difficult, if not impossible in some cases, to contact purchasers of medicines over the Internet in the event of a medicine recall.

New Zealand is one of the most popular suppliers of medicines over the Internet, with about $50 million of products being sold in 1999, mainly overseas. At present, approximately 30 Internet Pharmacies have been set up in New Zealand. New Zealand is an attractive market because of the relatively low price of our medical products and because s 33 Medicines Act 1981 allows an overseas resident to buy medicine from a New Zealand website without a prescription.

Section 33 of The Medicines Act 1981
Section 33 of the Medicines Act is headed:
33. Exemption in respect of procuring and exporting medicines:
The relevant part of section 33 states:
(b) Any person may export, in the course or for the purpose of sale, any medicine that, at the time when it is exported, might lawfully be sold by a pharmacist to a person in New Zealand, whether pursuant to a prescription or otherwise.

The full effect of this section was made clear in the District Court decision in Bell v Med Safe New Zealand Medicines and Medical Devices Safety Authority [2000] DCR 60.

The case involved an appeal by Kerry Bell, an Auckland pharmacist, against the Ministry of Health's decision to seize medicines that Mr Bell had been supplying to overseas buyers over the Internet. Some of these buyers did not have prescriptions for the prescription medicines they were purchasing. Over 1,000 original packs of prescription medicines were seized, which included medicines for hair loss, impotence, weight loss, antidepressants, diabetes, hormone replacement, fluid retention, prostate, high blood pressure, antibiotics, oral contraceptives, epilepsy, and asthma.

MedSafe argued that s 33 required a purposive reading considering the scheme of the overall Act, and that Mr Bell's activities was the very type of mischief that s 18 Medicines Act was intended to stop.

Judge Gittos adopted the general approach to statutory interpretation considering s 5 Interpretation Act 1999 (the meaning of an enactment "must be ascertained from its text and in the light of its purpose"). The Judge concluded that it was not possible to take a purposive approach towards interpreting s 33 because the text was already totally clear and unambiguous. The Judge found that the fair reading of the plain words of s 33, authorised the export in the course of sale or for the purpose of sale of any medicine that may lawfully be sold by a pharmacist. The authority extends to "any person" and includes "prescription medicines" which are specifically mentioned.

Although the provision may have been intended only to allow for the wholesale export of limited shelf life prescription medicines to countries in need of medical aid, its effect was to also allow activities such as Kerry Bell's.

The decision in Bell has prompted the Ministry of Health to seek an amendment to s 33 Medicines Act, to prohibit the export of prescription medicines for retail sale without a prescription.

Proposed Amendment to Section 33 of The Medicines Act
In "Proposed Amendments to the Medicines Regulations 1984 - A Consultation Document", March 2000, the Ministry of Health set out reasons for a proposed amendment to s 33. It identified the following reasons for amending s 33 Medicines Act to prohibit the export of prescription medicines for retail sale without a prescription, to:
- Bring New Zealand legislation in line with the rest of the world by stopping prescription medicines being sold to overseas consumers where the medicines have not been prescribed by an authorised prescriber either in New Zealand or the consumers' own country;
- Reduce the uncontrolled levels of sale, promotion, and advertising of medical products over the Internet;
- Stop sales of prescription medicines to consumers outside the authorized chain of distribution within New Zealand who may be impossible to locate in the event of a medicine recall; and
- Limit s 33 but still allow for the wholesale export of limited shelf life prescription medicines, by licensed pharmaceutical manufacturers and licensed wholesalers, to countries in need of medical aid.

In support of these reasons, the Ministry of Health has proposed to make a new regulation, under s 105(e) Medicines Act, to the effect that:
Section 33 shall not authorise any person to export, or supply in circumstances corresponding to retail sale, or distribute by way of gift, loan or sample, or in any other way, any prescription medicine otherwise than pursuant to a prescription (written by any person authorised to prescribe in New Zealand).

The proposed regulation will remove the existing anomaly and require New Zealand pharmacists (and anyone else) to obtain a prescription in all cases where prescription medicines are being exported or supplied from New Zealand.

At present, the proposed regulation is still a Cabinet paper but the Ministry of Health intends the new legislation to be in force by August or September 2000.

This is a general summary only and should not be taken as a substitute for specific advice

Russell McVeagh, law firm
Web site:Russell McVeagh
March 2001