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FDA and the Internet: Advertising and Promotion of Medical Products - Presentations (Day 2)

  

Contents

VOLUME I: Remarks   WWW 101   Group 1 Group 2   Presentations    Group 3
VOLUME II: Remarks Group 4   Presentations   Group 5

 

October 17, 1996

Presentations

J. Idanpaan-Heikkila, M.D.
Cedric Allenou
Manuel Montenegro
Bob Treherne
Heather Simmonds


Presentations

DR. NIGHTINGALE: We are going to have presentations by the five people who are here on this panel. If there is some time at the very end, we would consider taking some questions or comments from the audience, but we are going to try to stay on time.

Our first presenter is Dr. Idanpaan-Heikkila who is a clinical pharmacologist who was appointed Deputy Director of the Division of Drug Management and Policies at WHO in Geneva in 1990 and subsequently was appointed Director of the same Division in 1995.

Before joining WHO, he held the position of Chief Medical Officer for Drug Evaluation and Registration with the Finnish National Board of Health from 1971 to 1990. That is an equivalent organization to FDA. His job was analogous to that of CDER.

For the sake of full disclosure, Dr. Heikkila, in 1982 to 1983, spent a sabbatical year as a visiting scientist with the Food and Drug Administration here. He also spent a year as a Senior Advisor to the United Nations Fund for Drug Abuse Control in Vienna in 1989.

He was a member of the Commission on Narcotic Drugs from 1984 to 1987 and Chair of the Commission in 1986. Since 1990, he has been the WHO observer to the Steering Committee of the International Conference on Harmonization, the ICH.

We are very pleased that he could be here to not only present but to moderate the session this afternoon. It is his division at WHO that handles the information dissemination that is the liaison with the various drug regulatory authorities worldwide. It is his Division that performs the so-called normative functions at WHO that develop the various standards and ethical criteria.

So we are very fortunate to have him with us now.

Dr. Heikkila?

DR. HEIKKILA: Thank you, Mr. Chairman. Thank you, also, for inviting WHO to participate in this extremely important and interesting meeting.

I shall discuss today with you WHO ethical criteria for medicine and drug promotion. First, I should say a couple of words about the World Health Organization. Who is WHO? WHO is an intergovernmental organization and it is aimed to directly coordinate international health work.

It has 191 member states. Apparently, its main forum is the World Health Assembly which is a ministerial summit for ministers of health every year. This organization has a constitution and I have taken one sentence from the constitution which stipulates that, "WHO is to develop, establish and promote international standards for pharmaceutical and similar products."

Based on this constitution, the World Health Organization has drawn up ethical criteria for medicinal drug promotion. And from what we have heard yesterday and today, one can, perhaps, conclude that these criteria are still valid and can be used for any promotional activity.

Based on these criteria, the pharmaceutical industry has published its own code, and we will hear later today some details about this. The difference between these two criteria are that WHO criteria are to the governments to implement. The industry is to pharmaceutical companies to implement.

At the bottom, I have mentioned the World Federation on Proprietary Medicine Manufacturers who don't have any worldwide code. That means that OTC medications don't have today any agreed global criteria.

The WHO ethical criteria are aimed to support and encourage the improvement of healthcare through the rational views of medicinal drugs, as it is understandable that what is ethical might vary in different societies. Anyhow, WHO ethical criteria lay the foundation for proper behavior in promotional medicine and drugs. The promotion should be truthfulness, respect truthfulness, rightfulness and assist in judging what is acceptable.

What is promotion? According to this criteria, it is all informational and persuasive activities by drug manufacturers and distributors to induce the prescription supply, purchase and/or use of drugs. I think this covers all promotional activities including Internet.

Perhaps, one should never say what you should not do. You should be positive. Anyhow, these criteria exclude some things like the promotion should not contain misleading claims, unverifiable statements or contain omissions that might result in unnecessary drug use or undue risks.

The word "safe" should be only used if properly qualified. Whenever one compares different products, this should be factual, fair and capable of substantiation. All promotion-making claims concerning medicinal drugs should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation, in good taste. I think all this is applicable to Internet activities.

I have to pick up something that I feel is applicable to this meeting and from this criteria I have now taken only that part which addresses promotion to the public.

First of all, the criteria say that the promotion should help in making rational decisions on drugs legally available without a prescription. It should not take undue advantage of people's concern for their health. And promotion is not generally permitted for prescription drugs.

As far as I know, there is only one country in the world which actively agrees on promotion on prescription drugs. I think we stay in that country now. According to my knowledge, there are no other countries who actively promote that; further, not to promote drugs for serious conditions treated by qualified health practitioners, not to promote scheduled narcotics or psychotropic drugs, not directly at children, claim that a drug can cure, prevent or relieve only if this can be substantiated.

Finally, what is the format WHO recommends? The name of the active ingredient or ingredients should be mentioned, using an international, non-proprietary names, the international name, therefore, that anyone on the globe can understand what you mean with this active ingredient. Because we have one international name, we should us that.

We can add an approved generic name of the drug. One should have a brand name, major indications, major precautions, contraindications and warnings, and what is important concerning the Internet, once again, the name and address of the manufacturer or distributor.

Of course, the style of the language should be lay language and still it should have a basis on an approved scientific datasheet or other scientific basis for approval. This country talks about labeling. If you go to Europe, labeling is that small piece of paper you affix to the container.

So we prefer, on a global basis, the terminology, "product information data sheet," "approved product information," instead of labeling. But we understand when you talk about labeling and off-and on-labeling.

Finally, it should not cause fear or distress.

I should summarize by saying that WHO ethical criteria do not constitute legal obligations to member states. But they are recommendations to member states for their implementation through their national legislation and regulation. And they promote self-regulatory methods. I think that is what we have heard and, perhaps, agreed on in this conference already in regard to Internet.

Thank you.

DR. NIGHTINGALE: Thank you, Dr. Heikkila.

Our next presenter is Mr. Allenou. He is the Health Attache at the French Embassy in Washington. Before joining the French government, he was a junior product manager at Sandoz Pharmaceuticals in France.

He previously served as a pharmacist in a Paris hospital pharmacology division. He received his pharmacy degree from Paris University and also a Bachelor of Science in Biology and Pharmacology from the same institution. He also graduated from a French business school in Paris.

We will now present Mr. Allenou.

MR. ALLENOU: Good morning, ladies and gentlemen. Today I will present to you the latest development on Internet issues in France. First of all, in France, it is only the beginning but a very fast beginning on Internet. For example, approximately right now there are about 200,000 or 300,000 webservers in France.

Why this very low number? Because, basically, of two principle reasons; the low computer equipment rent in France but increasing. Last year, for example, the computer manufacturers sold more computers than car manufacturers sold cars.

Another reason, especially in France, is that we have a kind of a national Internet that is called the Militaire. It has been implemented by France Telecom. It is a network used by everybody, but not an international network.

Also in France, as in the United States, there is a lack of regulation on Internet promotion and distribution. But those issues will be soon discussed first of all by the French government, by regulatory agencies, the counterpart of the FDA in France--that is called the French Medicine Agencies--and, also, by manufacturers. The SNIP, which is the French Pharmaceutical Drug Manufacturers Association, has created a task force, a kind of think-tank on Internet issues.

So it is a very big concern for all the health professionals in France. Promotion and advertising are far more restrictive in France than in the U.S.A. In France, you are not allowed to do direct promotion to consumers. It is forbidden; only for small, specific classes of OTC in France, you can advertise. But for drugs, you can only advertise to health professionals, not consumers.

This is very important because this is a very big difference between France and the United States. But because of the lack of regulation, we don't know, really, what is going to happen to providers who are going to implement websites or who are going to advertise and promote their drugs.

For example, to advertise a drug in France, you need a visa, an authorization from the French Medical Agency that has regulated lots of things in drugs but also advertising. If you are not following these rules, you can get a penalty.

Distribution, also, is very regulated in France. There are not mail-order services. Mail-order services are not authorized to sell drugs. Drugs are only sold by pharmacists in retail pharmacies or in hospitals pharmacies. We don't have discount stores. You can get only drugs if you ask a pharmacist in France.

For example, on distribution and mail-order services, melatonin was a big concern and a big problem for French customs because lots of webservers in France had heard about providers that can send them, that can mail them, melatonin.

Right now, there is a big problem in France because lots of people, a lot of consumers, want to get melatonin from the United States, from other countries where it is available. It is not in France because the only drugs that are sold in France are drugs that are approved in France.

So, basically, we have the same problem as you right now, a lack of legislation, but a big concern for all the health providers from the government, from the regulatory agencies, from the pharmaceutical industry, and also from M.D.s, from pharmacists.

The Board of Pharmacy in France is very concerned because the distribution of drugs is very regulated and you cannot get drugs, only in retail pharmacies and in pharmacies in hospitals, as I told you. So it is a big concern in France.

We are going to soon implement laws or regulations. But right now, there is nothing we can tell you about a specific regulation in Internet issues, promotion and advertising in France.

Thank you. If you have any questions.

DR. NIGHTINGALE: Thank you. I would like to hold the questions until the end, depending on how we do in terms of the time.

Next is Mr. Montenegro who is Head of the Science and Technology Section of the Brazilian Embassy in Washington since January of 1994. Apart from his specific responsibilities there, Mr. Montenegro also designs and maintains the Embassy's webpage.

His previous experience includes five years at the Science and Technology Division of the Ministry of External Affairs in Brasilia, Brazil from 1989 to 1993. During that period, he was involved in introducing the use of the Internet as a resource for the Division.

At the same time, he was put in charge as Executive Secretary of the Latin American Technology Information Network of implementing that intergovernmental organization which is now based in Rio de Janeiro and of expanding its membership.

Before joining the Diplomatic Service in 1986, Mr. Montenegro was a book editor for the University of Brasilia press which he joined in 1979. He headed the editorial services section of the press from 1994 to 1995. Mr. Montenegro holds a B.A. and M.A. in international relations from the University of Brasilia as well as a degree in diplomacy from Brazil's Instituto Rio Branco Diplomatic Academy.

From 1990 to 1993, he was a lecturer in international theory at the University of Brasilia. He is presently enrolled in a Ph.D. program of the Political Science Department at George Washington University here.

Mr. Montenegro.

MR. MONTENEGRO: Good morning. Thank you for inviting me to this meeting. I must confess I was expecting a smaller meeting, but I am really glad that the impact of the Internet is so huge nowadays, that it involves so many people, so many professionals.

As you learned recently, I am not involved in the pharmaceutical area or the medical area. But what I would like to tell you about is the structure of registration of pharmaceutical products in Brazil, very briefly, then our use of the Internet and, lastly, about the efforts we are doing to regulate the Internet as much as is needed.

In Brazil, the Ministry of Health is responsible for keeping the registry of pharmaceutical products. Most of the industry in Brazil, the pharmaceutical industry, is controlled by transnational corporations so that we have had to devise a system to register products that are developed elsewhere.

In order to do that, we use our own standards, our own labs. However, we also find that FDA regulations as well as regulations from other countries provide useful information and guidelines. That is one of the things I do hear. I keep Brasilia informed of the latest FDA regulations which, of course, is a constant effort.

As to distribution in Brazil, it is similar to France, as you can only get drugs through pharmacists. But that is not to say that self-prescription is not a problem. The government has been actively involved in trying to keep that to a minimum or eliminate the problem.

However, as in the U.S., Brazilians are very concerned about their health. We have a long tradition of natural products. We have a very good market for that. People kind of make a jump from having teas and herbal potions to pharmaceuticals which, of course, work faster.

That is what tightly controlled in Brazil, via labeling. We have a similar system to the U.S. with labeling by color. We also have the same, or very similar, regulations concerning what should be displayed on the outside and what should be displayed in the information that goes to the consumer which is packaged along with the drug.

As to the Internet, as elsewhere, it has been growing explosively. The National Research Network which introduced the use of the Internet into Brazil and started out as the NSF with the academic sector is installing about 2,000 new servers a week.

We have about a half a million users, an estimated number, of course. Within less than a year, we will probably reach the 1 million mark. Commercial backbones are being established in Brazil in addition to the National Research Network, but the National Research Network, even though it is government funded, is open to commercial access providers.

The idea is to create a new industry for small and medium-sized firms that establish themselves throughout our territory to provide access via the National Research backbone and future backbones that may be established.

Of the growth of Internet use, one may say that it is mainly the commercial growth today, about 300 to 400 percent in growth a month, starting, of course, from a very low base. Meanwhile, the academic growth has sort of leveled and is now 100 percent which, for the Internet in Brazil, is slow growth.

I read somewhere that Brazil has become the second largest user in terms of hits in the world. It is just behind the U.S. This might reflect our very healthy computer market which is in the $7 billion to $9 billion a year range.

So the Internet is going to grow. It is going to become more commercial. We have strong content providers, strong technical on the technical side. And we are working to overcome our infrastructure problems with telephone lines. Basically, that is known as the "last hundred yard" problem here in Brazil. It is the "last hundred kilometer" problem.

As to the regulation of the Internet, the legal implications of the use of the Internet we see as just an extension of the coverage of domestic legislation so that the trend in Brazil is to apply existing legislation adapting it rather than writing new codes or new laws.

That is apparent in the current bill about hackerism. So one may say, safely, that Internet promotion, when it comes, of pharmaceutical products, when it comes to the Internet in Brazil, it will probably be dealt with by the Minister of Health Regulations and also by the Consumer Rights Code.

In recent years, this Consumer Rights Code has been used very extensively, very effectively, to protect the rights of Brazilian citizens and consumers. That is a big development over the last ten years in Brazil.

As to the adaptation of the Internet to domestic legislation, a big help is coming from the Internet Steering Board which is a body that was established over a year ago and that has representatives not only from government but also from the academic side, from business. It has an ombudsman and representatives from what we call "civil society."

This Internet Board is precisely in charge of charting this new territory, these new questions and issues that arise from the use of the Internet. They meet often. They are meeting today in Brasilia. They supervise a number of task forces.

The task forces have been designed to foster the growth of Internet use. One of them has been directed specifically for medical applications. We have examples of that at our website which is has a long address, www.brasil.emb.nw.dc.us, which is sort for the geographical location.

I brought a few pages that I will leave with the organizers and maybe they will be able to copy them if anyone is interested. One of the major applications that I find is the group of electronic publications in medicine, biology and health.

Another one is the Brazilian Virtual Hospital Project and other avant garde applications including a mirror site for the Visible Human Project which is one of the three international mirror sites of this project--I am sure you are familiar with it--out of the National Library of Medicine.

This task force is composed of the medicine applications. It is composed of people with experience in both the medical and the technical aspects. And they provide the input for the Internet Board recommendations. Of course, these will be taken into account when this issue of regulating promotion of pharmaceutical products on the Internet comes to the Brazilian Congress.

DR. NIGHTINGALE: Thank you very much.

Our next speaker is Mr. Treherne. He is a principal investigator with Australia's Therapeutic Goods Administration and is responsible for the investigation and prosecution of breaches of the Therapeutic Goods Act.

He spent 18 years as a police detective serving in the Australian federal police, South Australian police, and the Northern Territory police. He has considerable experience in the area of undercover drug operations, criminal investigation and criminal intelligence.

In 1990, he was head of the Plantation Unit of the Northern Territory Police Drug Enforcement Unit. Between 1992 and 1994, he represented the Northern Territory police at the Australian Bureau of Criminal Intelligence in Canberra.

During his time at the ABCI, he coordinated a national intelligence probe into organized crime in Australia. In February of this year, he represented the TGA at the National Police Research Unit's International in Melbourne on the Worldwide Web of Crime; Who is Controlling the Traffic.

Mr. Treherne.

MR. TREHERNE: Thank you and good morning. First, would you let me thank the FDA for their invitation to speak at this very important conference. The Australian experience, in relation to the Internet, is not dissimilar to the outline you have heard from my friends on the right.

Australians have a history of embracing new technology and the Internet is certainly no exception to that. There is currently an estimated 10 million computers permanently interconnected in this network of networks, plus myriads of small computers. There is an estimated 30 million users of which up to 700,000 are Australians. Its rate of growth is said to be doubling in less than a year so our neighbor is now anywhere in the world.

As with all new technology, the Internet opens up opportunities and presents us with new challenges. These challenges are particularly evident in the area of law enforcement and government regulatory agencies.

As you have heard, the Internet has no boundaries. It does not recognize geographical jurisdictions so even if we determine who is responsible for a particular activity, they might be out of our reach. While governments and law-enforcement agencies are confined by jurisdictional boundaries, criminals are not and they often attempt to use these boundaries to frustrate law-enforcement efforts.

Jurisdictional boundaries are quite transparent to the information infrastructure. A person can use it to commit a crime anywhere in the world and be quite insulated by those boundaries from the appropriate consequences.

The Australian government is committed to making available to all its citizens the fullest possible access to the information superhighway and to be sure that it enhances our lives rather than detracting from them.

In terms of Australia's regulatory system for therapeutic goods, the system is controlled by statute, the principal instrument being the Therapeutic Goods Act of 1989, which contains provisions for the evaluation and approval of drugs and devices which are either registered or listed on the Australian Register of Therapeutic Goods.

This legislation also includes a number of criminal offenses amongst which is the offense of advertising products with indications other than those that are approved. Every drug and device used in Australia is approved for particular indications and, under the Therapeutic Goods Act, it is an offense to advertise a product that is not approved.

Subordinate to the Therapeutic Goods Act are the Therapeutic Goods Regulations. These regulations contain an entire section specifically dealing with advertising. These regulations also give statutorywise a supporting code known as the Therapeutic Goods Advertising Code.

That code contains prohibitions in relation to prescribed claims that are made for therapeutic goods. Those claims cannot be made for any goods whatsoever regardless of whether the goods are approved or unapproved. For example, in Australia, it is illegal to advertise a product that claims to cure cancer, alcoholism or age, for instance.

The regulations also prohibit totally the advertising of prescription drugs. Having said that, the regulations also contain an exemption for the advertising of such products to healthcare professionals.

The basis of that legislation obviously recognizes that the healthcare professionals, because their experience and training, are able to make a determination as to the validity of the claims. It recognizes that the general public or the consumer does not have that ability and, hence, the advertising controls contained in the regulations apply to advertisements directed to members of the public, only.

Those exemptions only apply to offenses contained in the regulations and not to those contained in the Act. There is no such exemption for advertising an unapproved product or for advertising a product with indications other than those approved to either healthcare professionals exclusively or to members of the general public.

Under Australian legislation, it is an offense to import, export, manufacture or supply unapproved product. It is regarded as a serious criminal offense in our country. There are, however, a number of exemptions to this one of which is the personal-import scheme. The personal-import scheme is a procedure whereby the government allows members of the public to consume unapproved non-prescription medicines in Australia.

The scheme limits the importation of such medicines to three-months supply at the manufacturer's maximum recommended dosage for use by the importer or the importer's immediate family. Once imported under this scheme, the medicines cannot be sold or supplied to any other person.

There have been cases in Australia of multilevel marketing companies who sought to use the personal-import scheme as a means of importing commercial quantities of unapproved medicines and marketing them in Australia.

In order to overcome this difficulty, the Therapeutic Goods Regulations were amended effective as of the 31st of January of this year to prescribe the specific advertising offense for the advertising of unapproved medicines under the personal-import scheme.

This, in no way, detracts from the scheme. People can still import unapproved medicines for their own personal use. What the Amendment does, in effect, is prevent organizations from abusing that scheme. It prevents them from commercially exploiting it or bringing in commercial quantities and advertising unapproved medicines in our country.

The difficulty, of course, is that that legislation is confined to Australia. For example, if someone in Australia places on the Internet promotional material in relation to an unapproved product, or promotional material for a product which contains prescribed claims or promotional material for products for an indication other than those that have been approved, they clearly fall within the Australian jurisdiction.

The regulatory difficulty is that this legislation only applies to Australia. We are finding that multilevel market companies in the United States are placing a plethora of promotional material on the Internet that contravenes Australian legislation.

Generally, this material does not relate to prescription drugs but to over-the-counter non-prescription drugs and, invariably, the promotional material contains outrageous claims.

In reality, it is generally the multi-level marketing scheme that is being sold. It is the get-rich scheme, selling the product and building a downline. Quite often, the therapeutic goods or medicines are merely the vehicle for the scheme.

When that is the case, they usually claim to be cures for incurable diseases, or the "miracle product," a cure for AIDS, cancer or leukemia. And they are products that offer a solution to personal esthetics problems such as weight loss, baldness, that sort of thing.

Those groups--that is, the people suffering from incurable diseases or whose loved ones are suffering from such diseases and those people who are concerned with their appearance--are particularly vulnerable to this sort of advertising.

The products are generally promoted in an evangelical way and those vulnerable groups provide a good client base for multi-level marketing schemes. The types of products concerned are natural-base products such as ground up pelican meat to cure cancer, with some new extract from a plant or leaf.

The material will usually contain a lot of quasi-technical gobbledy-gook in relation to questionable clinical trials that have been conducted in relation to the product and, as such, the activity could be classed with more of a consumer fraud on a lot of occasions.

Finally, there are also provisions contained in the Customs Act and their subordinate regulations, in particular the Customs Prohibitive Imports Regulations which contain a number of schedules that determine things are prohibited imports.

For example, it determines that narcotic drugs, steroids and cocaine are prohibited imports. It determines that certain firearms and explosives are prohibited imports and it also determines the promotional material for therapeutic goods containing false or misleading statements to be a prohibited import into Australia.

In conclusion, the Commonwealth Government of Australia is committed to developing strategies which incorporate an effective self-regulatory scheme including a Code of Practice and Complaints procedure, a comprehensive education strategy and the introduction of offense provisions to provide sanctions against persons who deliberately breach community standards.

Thank you.

DR. NIGHTINGALE: Thank you very much.

Our final presenter on the panel is Heather Simmonds. Heather Simmonds is the Secretary of the Prescription Medicines Code of Practice Authority which was established by the Association of the British Pharmaceutical Industry, ABPI, at the beginning of 1993 to take over the administration of the ABPI Code of Practice for the pharmaceutical industry. ABPI is analogous to the Pharma in the United States.

She has a degree in pharmacology and joined ABPI in 1984. She has been working full time on the Code of Practice over the past seven years.

MS. SIMMONDS: Thank you very much. Thank you first to the FDA for inviting me to this meeting. I have certainly learned a lot and got a lot of important messages to take back to the U.K..

It is also a long time since I have had a gold star on any of my materials and I would thank the FDA for that on my badge.

My brief is to discuss the experiences and promotion of prescription medicines on the Internet in the U.K. and the thoughts that went behind the guidance that we at the Code of Practice Authority have issued. The guidance, I should stress right at the outset, is for discussion purposes and to raise awareness of the appropriate clauses of the Code. It is by no means written in tablets of stone.

The ABPI is the trade association in the U.K.. It stands for the Association of the British Pharmaceutical Industry. And, as the Chairman has said, it set up the PMCPA in 1993 to administer its Code.

This is a picture of the 1996 edition of the Code. It was established in 1958. We have a long history of self-regulation in the U.K.. It covers all the legal requirements in the U.K. and goes beyond. It covers the international code that was referred to earlier as well as the European code. We also cover the majority of the WHO ethical criteria referred to by a previous speaker.

We are dealing with the promotions of medicines to healthcare professionals for prescribing purposes. We don't cover the promotion of OTC medicines. That is dealt with by another system.

So where are we as far as the Internet is concerned. There is no reference to the Internet in the U.K. code or in the U.K. advertising regulations. As of last Friday, we haven't received any complaints to date about material on the Internet. If one has come in this week, I do not know about it. It would have spoiled my slide.

The other important point is the PMCPA has limited knowledge about the Internet. And we are not the final arbiter. I should just, perhaps, explain the system in the U.K. is based on complaints and a complaint is considered by three people on a panel to start with.

I am one member of the panel and we make the initial decision. The decision can be appealed to a body known as the Code of Practice Appeal Board, and it is that body that has the last word on complaints. They are, if you like, the equivalent to the House of Lords in the U.K..

So we actually received an enormous number of inquiries about the information on advertising on the Internet. So we decided at the Authority that we should issue some guidance to respond to companies and to advise companies. It was taking a lot of my time discussing these issues on the telephone every day and it was considered easier to have something in writing that we could hand out as a starting point.

It is only guidance. We have been accused of trying to rule the world as far as the Internet is concerned, and I assure you that is not the case. We are going to be developing our guidance based on developments and, obviously, the outcome of meetings such as this.

What we had to do, though, was to issue something so that companies could start. But I am very much talking theory at the moment. So what we did was we took the principles of the Code and tried to see how they would apply to the Internet.

The Guidance was issued in our Code of Practice Review. I don't know if any of you are familiar with this. This is a document which has the principal purpose of giving details at the outcome of all complaints we receive, and we also push in there detailed guidance and helpful tips and, perhaps, problems that have come up over the last quarter.

It is available to anybody. I will leave copies with Ilisa and if you need photocopies, get them, or you can contact me for copies.

The Licensing Authority in the U.K. have seen the guidance and they haven't disagreed with it. I am quite different from the different speakers in that I come from the trade association and not the government. The MCA have not issued anything themselves in the U.K. about the Internet, but they seem to broadly go along with our views.

They are, at the moment--I found a standard prosecuting a company mail-order medicines on the Internet but that is still very much at the early stages, I understand.

So our starting point was that many of the Code's requirements would apply to material on the Internet. The Code deals with communication. In a way, the method of communication is almost seen as being as irrelevant. There are two factors that we needed to take into account, if we ever get a complaint about material on the Internet.

The first is jurisdiction. Do we, in the U.K., have jurisdiction? If we get a complaint, we will always approach the company in the U.K. first. We don't have any jurisdiction over Glaxo Wellcome in the States, for example. We would contact Glaxo Wellcome in the U.K..

Jurisdiction is a very tricky point. Now, the theory we have got so far is that if material is put on the Internet by a company operating in the U.K., it is potentially subject to the U.K. Code. This has been developed from our guidance about international journals.

If an advertisement appears in an international journal and that journal is produced in English in the U.K., and even if only a small proportion is circulated to a U.K. audience, then it is covered by the U.K. Code.

So, as I say, if a company in the U.K. puts information on the Internet, it is potentially subject to the U.K. Code. What about if a company outside the U.K. puts material on the Internet? Well, our thoughts at the moment are if that information refers specifically to the U.K. use of a product, then the U.K. Code might apply. We would have to judge it on its content.

If, however, the material is put out by a company in the U.S.A, and it complies with the U.S.A rules, we wouldn't have any jurisdiction. A good example of this is the Journal of the American Medical Association. It is, of course, very widely available in America. It is aimed at members of the American Medical Association.

It does come to the U.K.. U.K. health professionals see it. They see the advertisements in that journal. Nobody in the U.K. is suggesting that those advertisements need to be in accordance with the U.K. Code and the U.K. law. If they meet the U.S.A requirements, that it fine as far as we are concerned.

If, however, a company decides that they will put things on the Internet via, perhaps, Outer Mongolia or somewhere like that as a means of avoiding any sort of restrictions, we would argue that the U.K. Code might have an application in such a situation depending on the content of the material.

The next problem is the audience. As some of our speakers have mentioned, in the U.K. and in Europe, you cannot advertise prescription-only medicines and certain pharmacy medicines to the general public. That is a European-directive prohibition.

So anything that is put on the Internet is open-access format needs to comply with the rules relating to information to the general public. Obviously, in the U.S.A, you can have direct-to-consumer advertising but in the U.K., you can't. So if a company in the U.K. wants to put up open access information, there are certain types of information that has been put on the Internet.

The first is disease-area information. The second are what we call summaries of product characteristics or datasheets. Now, somebody explained earlier that this actually means labeling in the U.S.A, although I see a label as a little thing that gets stuck on the outside of a packet or something.

But what they are; they are very detailed product particulars and they are approved by the regulatory authorities and they are issues as a prime document, if you like. All your promotion has to be in accordance with your SPC.

The SPC is a sort of European term. All products in Europe will be moving towards having summaries of product characteristics. So a company could put that up on the Internet. They could put up their patient-pack information leaflets on the Internet.

The basis for this is the patient-pack information leaflet is also approved by the regulatory authorities before it can be placed in the pack. These two documents are actually incorporated in compendia released by the ABPI. We have a datasheet compendium or an SPC compendium, and a compendium of patient information leaflets.

These compendia are available in reference libraries. Members of the public can go and consult them so it seems logical that this sort of information could be put up on open access in the U.K. for the general public. The other sorts of things might be annual reports and such like.

Moving on to closed access, this is becoming a little bit more popular in the U.K.. A number of companies are spending some time sorting out closed user groups for information on the Internet. If your user group is health professionals, you can promote and advertise as you would in print media or any other type of advertising.

You need to have some sort of secure system. It wouldn't be sufficient just to say, "Are you a health professional? Click on here yes or no," because, of course, anybody can access that information. Companies are looking at passwords and this sort of thing to give health professionals access to more information that complies with the U.K. Code.

So, to conclude, I am afraid contrary to what people were saying yesterday, we were of the view when we wrote the guidance that the Internet is merely another means of communication with the principles of the Code applying. In time, case precedence will clarify the issues and provide further guidance.

Thank you.

DR. NIGHTINGALE: We are right on time, but I guess I would ask are there one or two questions for the panel? Is there any burning desire to ask one or two questions? Do any of the panelists wish to ask any other panelist a question?

MR. SCOTT: Mike Scott, CoMed Communications. Does the FDA have any view whatsoever at the moment on attempting to restrict people from outside the U.S. trying to look at Internet sites within the U.S.? I have been asked this question by a number of my clients.

On the sites we are building, we are attempting to do that, but I would be curious as to whether there was any view on that whatsoever at the present time understanding that this is not a final comment.

DR. NIGHTINGALE: I would like to save that question for the panel that comes up in our discussion after lunch.

Then, let's meet back here at 1 o'clock and we will continue then. Thank you to the panel.

[Whereupon, at 12 o'clock p.m., the proceedings were recessed, to be resumed at 1 o'clock p.m.]