Bringing the latest veterinary medicine to Japan
Keeping animals healthy is a critical job, not just for the sake of the animals, but for us humans too. Healthy livestock means a safe food supply, while healthy pets enhance the lives of their owners.
The welfare of animals is underpinned by a market for animal health products, which in Japan is worth more than ¥80 billion a year. This market consists of products that fall into two main categories: pharmaceutical (conventional veterinary drugs) and biological (products based on biotechnology, such as vaccines).
Although the market for animal health products in Japan has seen steady, consistent growth in recent years, the EBC Animal Health Committee continues to try to convince the Ministry of Agriculture, Forestry and Fisheries (MAFF) to harmonise and streamline its approval requirements so that farmers and pet owners can get access to the best and latest European products.
“We’ve made a lot of progress over the past 10 years or so,” says committee chairman Dr Tadashi Nagata. He also notes, however, that foreign products can require extensive testing – even after they’ve been proven safe and effective in Europe and elsewhere.
A related issue is industry’s good manufacturing practice (GMP). This means that MAFF must accredit factories in Europe that produce veterinary drugs for export to Japan before the product is approved.
“Normally, we assume that if a product has been approved by a European authority, then it’s going to be OK. However, that doesn’t mean it’s going to be approved automatically by Japan,” says Nagata, who is a director at Merial Japan.
That’s why the committee advocates harmonisation of Japan’s regulatory requirements with those of Europe, the United States and other developed countries. Efforts to accomplish this are taking place through the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), a programme made up of government agencies and industry associations from Japan, the United States and the EU.
One committee member, who prefers not to be named, believes that MAFF officials could move more quickly to bring their requirements in line with those of other countries and predicts that eventually they will. “The standards have existed for some years,” the member says. “They have investigated the issue intensively, and I believe the time is right now to make a positive decision.”
Yet, at heart the issue isn’t protectionism, according to the member. Rather, it’s Japanese regulators and other bureaucrats who prefer to remain in their comfort zone, shying away from bold action that could potentially disrupt Japan’s existing regulatory system.
The committee points out that unique requirements here often mean that the latest innovative veterinary drugs never make it to Japan.
For example, the committee member points to minor formulation changes that improve product stability or ease of application. In such cases, studies are required to prove the new formulation is as effective as the previous one.
In a typical case, a foreign manufacturer will gain approval for the changes based on internationally accepted trials in their home markets. However, Japanese regulators don’t recognise the results, and so the manufacturer is sometimes forced to redo the trials in Japan.
How does this block the product’s entry into Japan? Because many companies simply don’t bother selling the newer formulations in Japan. The cost and time aren’t worth it. “They would have to go through a lengthy process – sometimes including unnecessary animal trials, and that for many is not acceptable, not from an animal welfare point of view and not from a business point of view,” says the committee member. “There isn’t much gain for the industry, although there would be a lot of gain for the farmer.”
Globally, the market for veterinary medicines, vaccines and related products is split roughly between livestock (65%) and pets (35%), which industry people call “companion animals”. In Japan, the ratio is skewed somewhat toward pets, which account for 40% of the total. The main reasons for the difference are Japan’s “pet boom” of the last decade or so, and the fact that the country’s small-scale farming isn’t well suited to handling large herds of livestock.
Japan’s market for animal health products is extremely stable. “The market grows at maybe 1 or 1.5% over the long term, as opposed to a world market growth of maybe 3%, or 3% to 4%,” says Eberhard Baehr, a committee member who serves as country division head of the animal health division of Bayer Yakuhin. “But, then, we don’t have to deal with any drastic downturns either,” he adds.
The committee holds face-to-face meetings with Japan’s regulatory authorities several times a year. A meeting on 27 April was held with MAFF officials and a joint team of committee members and representatives of United States companies.
As for future trends in Japan’s animal health market, look to human health, advises Nagata. Foreign drugs manufacturers here have long had to jump through the same kind of regulatory hoops as their counterparts in the veterinary field – but have also seen a lot of solid progress in recent years.
Nagata says, “I don’t know how many years we’re behind, but we’re quite optimistic that what has been achieved in human medicine can be done for us in the coming years.”