September 20, 2007

By Laura MacInnis

GENEVA, Sept 20 (Reuters) - Improving access to medicine could save 10 million lives a year globally, a U.N. health envoy said on Thursday, recommending that drugmakers support research for neglected diseases and cut prices in poor countries.

Paul Hunt, an independent U.N. expert on the right to health, estimated that 2 billion people worldwide cannot get the essential drugs they need.

In about 50 recommendations released by the Office of the U.N. High Commissioner for Human Rights, Hunt urged drugmakers to charge less for medicines in poorer markets and allow developing states flexibility in accessing cheaper generics.

“It is time to identify what pharmaceutical companies should do to help realise the human right to medicine. How can we expect pharmaceutical companies to respect human rights if we fail to explain what they’re expected to do?” he said.

“The price of medicine in a low-income country should be less than the price of the same or equivalent medicine in a middle-income country, which should be less than the price of the same or equivalent medicine in a high-income country.”

Just 15 percent of the global population consumes more than 90 percent of the world’s pharmaceuticals, he added.

On patents, one of the most contentious issues in public health, Hunt said it was important pharmaceutical companies respect World Trade Organisation (WTO) rules and ease off lobbying for stricter patent protection in poorer states.

“The company should not extend patent duration, or file patents for new indications for existing medicines, in low-income and middle-income countries,” his guidelines said.

Read more on the need for better access to medicine.

Article Date: 04 Jun 2008 - 3:00 PDT

Secretary of State for International Development (UK), Douglas Alexander, has launched a powerful new health alliance which could save the lives of 10.5 million people in developing countries each year by 2015.

International institutions, the World Health Organization, the World Bank, governments, civil society and business have joined together to form the Medicines Transparency Alliance (MeTA) to improve the health and lives of millions of people. Currently one in three people around the world still don’t have access to the basic medicines they need to fight illness and ten million children die each year for want of cheap and effective drugs.

Up to a third of medicines on the market in developing countries are fakes and a recent study published by the American Enterprise Institute found that a third of malaria drugs sold in six African cities either did not contain high enough levels of active ingredient, or did not dissolve properly.

Douglas Alexander said:

"Too many people die needlessly because they can’t get the medicines they need. There are currently 2 billion people around the world who do not have access to affordable medical services. A lot of medicines are not affordable, they are of poor quality, or they are simply not available.

"The problems of price, quality and availability can be tackled by improving transparency and access to information. MeTA will provide citizens, health care workers and others with information to challenge corruption, excessive pricing and waste. We now have a common approach and by working together millions of lives could be saved."

In Ghana, the lowest paid government worker - who still earns more than half of their fellow countrymen and women - would have to work for a week simply to afford a course of malaria treatment.

Read the rest of this article on providing access to medicine for developing countries.

By Monica Lafon
Published: March. 16, 2009 at 1:37 PM

In 1998, Dr. James Orbinski was at a Doctors Without Borders clinic in the slum settlement of Kibera outside Nairobi, Kenya. He was part of a team offering treatment for malaria and diarrhea, and was also setting up an HIV prevention program. He sat in the clinic examining a 5-year-old girl with malaria who, after three days of standard chloroquine treatment, was still vomiting and running a fever. “Her malaria was clearly resistant to the medicine. Drug resistance is a natural phenomenon, and all infectious diseases eventually develop resistance. New drugs must constantly be found,” Orbinski recounted in his book, “An Imperfect Offering.” “Every year, worldwide, almost two million people die of malaria; 90 percent of these deaths occur in Africa, and because children have more delicate immune systems, 800,000 of those who die are children,” he wrote.

When Orbinski gave a lecture at Concordia University in Canada on “Global Health and Humanitarianism” on Sept. 25, 2008, he spoke about his experiences as president of DWB in Rwanda and about his work on HIV/AIDS, encouraging the audience to take action.

After DWB was awarded the Nobel Peace Prize in 1999, Orbinski dedicated the money toward the development of drugs for the “neglected” diseases. This was how the Drugs for Neglected Diseases initiative was born. He announced the release of two new anti-malaria drugs.

In an interview, he explained that because malaria develops drug resistance, it is not simply cured with one treatment. In 1999, a public-private partnership, the Medicines for Malaria Venture, was set up to develop new drugs for malaria, but the process could take up to 10 years. “In the short term, there is an enormous need for drugs,” he said. “500 million people can’t wait for what may come.”

In his book, he explained that the Neglected Diseases Working group thought that by combining two existing anti-malaria drugs into one tablet, they might be able to develop an effective treatment in the short term.

“The problem was real and immediate, but there seemed to be no way to get anyone to do anything about it,” he said. “With no viable alternatives on the landscape, we decided to do it ourselves.”

In Oslo, when he gave his Nobel Prize address in 1999, he spoke of injustice outside the context of war. “Ninety percent of all death and suffering from infectious diseases occurred in the developing world,” he wrote in his book. “Around the world, two billion people had no access to essential medicines. Poverty is a driving force behind poor health, and that was not a problem we could solve. But as doctors, the lack of access to medicines was an injustice we could do something about.”

The fight for essential medicines was DWB’s next challenge. A global campaign was launched, drawing in more than 100 different non-governmental organizations as well as the World Health Organization. It was led by Dr. Bernard Pecoul, former general director of DWB in Paris, and Daniel Berman, a former marketing executive in the pharmaceutical industry.

In 2001, when Orbinski finished his term as DWB president, he worked as chairman of the Neglected Diseases Working Group. The question was, why was there so little drug research for diseases that affect those in the developing world?

“Returns on investment are not good enough for pharmaceutical industry and they are driven by profit,” he wrote in his book. “Governments have failed to ensure that wealth created by patent monopolies is directed towards global health needs.”

Thus DNDi was born. It was launched in 2003 as a not-for-profit pharmaceutical research and development organization that focused on four neglected diseases: sleeping sickness, chagas disease, leishmaniasis and malaria, all of which are neglected because their manifestation occurs in developing countries, where patients are too poor to attract investment for drug research.

Neglected diseases can be cured. The DNDi Web site defines malaria as the single largest cause of death for children under 5 in Africa, killing one child every 30 seconds, or 3,000 children every day.

A group of 40 scientists, drug policy analysts and drug development specialists as well as the WHO got involved in the DNDi. They surveyed the top 20 pharmaceutical companies in the world with Harvard University, and found that among the 11 companies that responded, eight spent nothing on research and development for diseases like African sleeping sickness.

They also found that only 0.2 percent of the $60 billion spent globally every year on drug research and development went towards tuberculosis, malaria and other diseases, which account for 18 percent of global mortality from all diseases.

Over the course of two years, they established a network of 15 African research centers linked with DWB, the Pasteur Institute and medical research councils in India, Malaysia, Brazil and South Africa.

Read the rest of this article on Dr. Orbinski’s access to medicine fight.

If companies want to cut into sales of counterfeit products, they need to understand why consumers buy them in the first place

By  PEGGY E. CHAUDHRY And  STEPHEN A. STUMPF

As the counterfeit trade booms, companies are rolling out massive campaigns to get people to stop buying fakes. But the messages they use are often off the mark.

Companies have tried everything from threatening prosecution to linking phony products with organized crime. But marketers often don’t pay attention to what actually drives people in particular markets to buy counterfeits and what messages will actually work to curb demand of fake goods.

Companies, for instance, might roll out ads in a country stressing that fake products are of poor quality. But those ads might ignore the fact that local consumers have little disposable income and consider knockoffs a bargain—so they are willing to accept a price-quality trade-off. A better approach might be to stress that the phony goods, such as fake cigarettes, are funding terrorism or, in the case of counterfeit pharmaceuticals, are actually killing people.

To figure out how companies can improve their antipiracy marketing, we surveyed consumers in five large markets—Brazil, Russia, India, China and the U.S.—to see what would make them opt for knockoffs. Then we used that information to figure out what messages might get people to stop buying the illegitimate goods.

WHY CONSUMERS BUY

We presented consumers in each market with five possible motivations for buying counterfeits in two categories—movies and drugs—and asked them to rank the factors on a seven-point scale of importance. Here’s what they said about each.

1. Quality and performance. Consumers would buy a fake if they thought it was just as good as a legitimate product.

Only U.S. consumers ranked this as an important factor that would influence them. Elsewhere, this attribute was just "somewhat" important—and Russian consumers ranked it not important at all. Astonishingly, consumers in these country markets valued the quality of the fake medicine less than they did factors such as reduced price and availability.

On the other hand, the quality of bootleg movies was ranked as very important for Russian, Brazilian and Chinese consumers, and less so for people in the U.S. and India.

2. Cost. Consumers would buy a fake because they cannot afford a genuine product.

Not surprisingly, almost all consumers ranked this as a very important motivation for pursuing fake drugs and bootleg movies alike. The two exceptions: Chinese consumers said this factor was only somewhat important when it came to drugs; U.S. consumers said the same about movies.

3. Sentiment. Consumers would buy a fake because they do not like the big businesses that make the authentic products.

We expected some resentment here, since drugs and movies are usually produced by large corporations, and the people who buy counterfeits may believe that the industry is price-gouging consumers. But only in China did consumers express disapproval of the large movie studios as a significant motivator for buying bootlegs. And only U.S. consumers showed an anti-big-business sentiment for both the movie and drug industries.

Their Brazilian, Russian and Indian counterparts did not concur, and rated this as an unimportant justification.

4. Ethics. Consumers would buy a fake because they do not think it is illegal or immoral to do so.

In this area, consumers had very different attitudes about movies and drugs.

In Brazil, India and the U.S., consumers said that consumption of fake pharmaceuticals was an unethical behavior. In Russia and China, it was not important at all—in effect, consumers would buy the fake pharmaceuticals even if they realized it was an immoral or illegal act.

With movies, on the other hand, consumers in all markets but Brazil said that ethical behavior was unimportant when it came to obtaining counterfeit movies. (In Brazil, it was just somewhat unimportant.) These consumers simply do not see bootlegged movies as illegal or morally wrong, perhaps because of the ease and anonymity of Internet downloads and the widespread consumer acceptance of obtaining fake movies. In our survey, 50% of 1,910 consumers readily admitted to obtaining a bootleg movie.

5. Ease. Consumers would buy a fake because it is easy to obtain.

As with ethics, this factor brought up a big divide between movies and drugs. The ease of obtaining fake movies was a very important motivation in each market. However, with drugs, ease was an important factor only in the U.S., just somewhat significant in Brazil and India, and not significant at all in China and Russia.

Consumers, in other words, face different degrees of easy market access to counterfeit drugs and may pursue counterfeit drugs even if they are tougher to obtain.

Read the rest of this article on counterfeit products and fake medicine on the Wall Street Journal Web site.

By David E. Rogers, Squire, Sanders & Dempsey L.L.P. and Amy L. Hartzer, IsoPatent
Aug. 12, 2009

International competition is increasing daily. Competitors are nimble and quick to copy, and customers are demanding and looking for the best price. Brand name and personal relationships still carry some weight, but not as in years past. One way for U.S. manufacturers to compete effectively in today’s marketplace is by controlling innovation through intellectual property ("IP"). Given the international nature of business, IP protection should also be international and, to the extent cost effective, coextensive with a business’ current and future market presence.

We suggest a three-step approach to creating an international IP portfolio. First, regardless of location, always utilize contracts and trade secrets with employees and business partners, such as suppliers, distributors and contractors. Second, if practical, use patents to both (i) fortify the protection provided by contracts and trade secrets, and (ii) protect your technology from entities with which you have no contractual relationship. Third, select the countries in which you desire patent protection, which are usually those in which your products are sold or will be sold, and then implement your IP strategy.

Below we explain the IP protection mechanisms, how to select the countries in which patent protection should be obtained, and two case studies that apply these principles.

(1) The IP Protection Mechanisms: Contracts, Trade Secrets and Patents.

(a) Contracts: Whether or not your technology is protected by a patent, it may still be protected by contract. Contracts should always be used with employees and your direct business partners, such as suppliers, distributors and contractors. Contractual protection may even be suitable for customers (for example, if you already enter into contracts with customers to sell industrial machinery.)

The contracts should require your employees and business partners to (i) maintain the confidentiality of business information (such as your technology, designs, marketing plans, costs, selling prices, and the identity of vendors and customers), (ii) not compete with you during the term of the contract and for a reasonable period of time (usually one to five years) thereafter, and (iii) assign improvements to your technology to you.

You can usually select the law that governs a contract and the locale for resolving contract disputes. Select the law of one of the United States that is likely to uphold the contract’s provisions (particularly the non-compete clause) and require any dispute to be resolved in a U.S. court or in arbitration in the U.S. If your employee or business partner is outside of the U.S., check with an attorney in the country where your employee or business partner is located to ensure the contract provisions are enforceable there.

The costs to enter into contracts are the legal fees associated with preparing and negotiating them. Depending on a contract’s complexity and the length of negotiations, plan on about $3,000 - $10,000 per contract with each business partner. The costs for employee contracts are usually negligible.

(b) Trade Secrets: A trade secret is information that both: (1) derives actual or potential economic value from not being generally known and not being readily ascertainable to others by proper means, and (2) is the subject of reasonable efforts to maintain its secrecy. Trade secrets cost nothing to obtain, although maintaining them requires some expense because each person or business exposed to the trade secret should execute a contract with an appropriate confidentiality provision (also called a non-disclosure provision).

Here, all persons and businesses that executed contracts in the preceding Section (a) would be bound to maintain the confidentiality of your business information. By using contracts and other reasonable efforts to maintain the secrecy of your information, trade secret protection protects against the misappropriation of your information by anyone, even persons with whom you have no contractual relationship. That is the added benefit of trade secrets as compared to contracts.

Information that cannot be maintained as a secret includes (1) publicly-available product designs, and (2) things that can be reverse engineered, such as (i) internal components that can be discovered through disassembly of a product, and (ii) material compositions that can be ascertained through laboratory analysis.

Trade secrets have at least one advantage over patents. In many countries, including the U.S., trade secret life is potentially indefinite whereas a patent’s life is typically 20 years from the original patent application filing date.

A major disadvantage of trade secrets is that they do not protect against independent development by a competitor, whereas patents do. Further, once a trade secret has been disclosed to numerous people, even with the proper confidentiality agreements in place, it can be misappropriated without you knowing who was responsible.

Read the rest of this article on pharmaceutical patent and other intellectual property issues on IndustryWeek.com.