Five major problems of pharmaceutical exports to be solved

Pharmaceutical Network November 22 hearing this year, the global economy continued to maintain a mild recovery, the growth rate of international trade has accelerated in the field of medicine, although the traditional foreign trade competition weakened competition, industry and price competition, but with the effect of national policy The new momentum of supporting the development of foreign trade in pharmaceutical products is accelerating the accumulation of quality and efficiency, the structure of foreign trade continues to be optimized, and the stable and prosperous medical trade throughout the year has already been formed.

In the first three quarters of 2017, China's total foreign trade in medicine was 84.953 billion U.S. dollars, up 10.71% over the same period of 2006. Of this total, the exports were 43.678 billion U.S. dollars, up by 5.61% over the same period of last year; the import was 41.275 billion U.S. dollars, up 16.66% over the same period of 2006. The surplus was 2.403 billion U.S. dollars, down 59.8% Subdivided into three major categories of commodities, the export value of Chinese medicine was 2.6 billion U.S. dollars, down 0.27% on a year - on - year basis while the exports of western medicine were 25.395 billion U.S. dollars, up 8.44% on a year - on - year basis. medical instruments The export volume reached 15.684 billion U.S. dollars, up by 2.29% on a year-on-year basis.

January to September, China's import of medical products 41.275 billion US dollars, almost balanced with the export volume, import growth rate higher than the export 11.05 percentage points, among which, the prices of traditional Chinese medicine and medical equipment increased at a lower price, while that of western medicine doubled.

At present, China's imports are dominated by high-end medical equipment, pharmaceutical equipment and western medicine and are highly complementary to the domestic industries. They can improve domestic supply and help industrial restructuring, upgrading and livelihood improvement.

The first three quarters of China's pharmaceutical exports to 225 countries and regions, Asia, Europe and North America are the major export markets, exports were 179.25 billion, 114.2 million and 8.568 billion US dollars, accounting for up to 86.8%. Europe and North America China's import of pharmaceutical products is the main source of imports from North America, an increase of 17.73%, imports from Europe increased 18.05%, reflecting the advantages of European and American products is still solid.

In addition, the country's import and export of pharmaceuticals along the Belt and Road rose by 19.95% and 5.75% respectively over the same period of last year with a 144.32% increase in imports from Iran and a 94.72% increase in imports from Turkey. The Belt and Road initiative is underway in medicine Solid progress in mutually beneficial cooperation in the field.

Private and foreign capital enterprise Is the two main force of the foreign trade of medical insurance products in our country.The operation teams of the two are steady and increase, the performance increase is more obvious.

From January to September, private-owned enterprises accounted for 79.62% of the total exporters, accounting for 67.72% of the total exports and 53.69% of the total exports, an increase of 8.05% over the same period of last year.

In the area of ​​imports, foreign-funded enterprises have obvious advantages. The number of importers accounts for 37.36% of the total imports, and the import amounts to 68.77% and 61.05% respectively. The import volume has increased by 19.34% over the same period of last year.

From January to September, the top five exports accounted for Jiangsu, Zhejiang, Guangdong, Shanghai and Shandong, with the growth rate of 14.95% in Jiangsu, the largest export province among the three northeastern provinces And the central and western provinces are in contrast: Ningxia grew by 28.32% and Xinjiang increased by 18.18%, while Guizhou and Yunnan also dropped by 54.68% and 26.83% respectively from the first quarter of this year to 4.8% and 2.89% at present; the three northeastern provinces fell across the board While the exports of Heilongjiang, Jilin and Liaoning decreased by 19.98%, 12.58% and 2.76% respectively, and the pattern of weakening of the east, the west and the west would not change much in the short term.

In recent years, the state has made great efforts to promote supply-side structural reforms and made progress, but the problem of overcapacity of bulk raw materials is hard to be solved in the short term. Facing the fierce market competition, the export prices of bulk raw materials are dropping all the time, , Profit margins continue to be squeezed.At the same time, some domestic minority pharmaceutical raw materials due to fewer manufacturers, low output, there is a monopoly price increase or circulation, the preparation of the exclusive purchase of pharmaceutical companies, resulting in other formulations manufacturers have to get high prices And then pushed up the export price of the formulation.Many preparation companies because of the goods out of stock, such as cimetidine, lidocaine, oxytocin and other niche products directly to the market.

First, a large number of raw material drug companies are facing the dilemma of limited production due to environmental problems such as Taizhou, Zhejiang Province, there are already many pharmaceutical intermediates have been shut down, Beijing requires raw material drug manufacturers in November heating season all discontinued production, Beijing, Tianjin and Hebei require the pharmaceutical industry to implement peak-shifting production during the heating season.

Second, the pharmaceutical industry pollution standards gradually improved.Revised version of the "emission standards for air pollutants in the pharmaceutical industry," with reference to the experience of Europe, the United States and Japan and other countries, the implementation of the sewage permit system, some of which indicators more stringent than the more developed countries.

Third, long-term suspension of production led to a shortage of domestic products related products, some international orders can not be implemented normally, directly facing the risk of economic compensation and loss of the market.

For example, some leading pharmaceutical enterprises in Hebei Province have invested heavily in environmental upgrading and upgrading, although the relevant requirements have been met, they are treated as "non-discriminatory" with respect to non-compliance with environmental protection measures before the stop-limiting measures are implemented.

Recently, the Health Insurance Chamber of Commerce investigated some economic and technological development zones, pharmaceutical industrial parks and related enterprises.Although more attention has been paid to scientific and technological innovation in various places, there are still some problems such as insufficient input and serious homogeneity of enterprise products, etc. Some enterprises even have R & D costs less than Some of the ETDZs and industrial parks are located in the Midwest. R & D resources at a high level are relatively scarce, high-level R & D personnel are relatively scarce, science and technology innovation bases are relatively weak, lack of attraction High-end talent, venture capital and other high-quality elements gathered platform for the carrier, corporate innovation and R & D capability is not strong, independent intellectual property rights and less well-known brands, innovative leaders rare.

The long period of reviewing new drugs is a problem that the industry reflects more prominently. At present, the registration of an imported drug still takes 5-8 years. In addition, international registration of drugs requires a lot of manpower and financial resources, and the shortages and high costs of the relevant national registration certificates Is also a hot topic of concern to enterprises, such as Gansu, the United States and near the reflection of Australia (TGA) certification cycle is short, only two years of validity, and certification costs high, each product up 400,000 ~ 500,000 yuan / times; Product registration due to identity, different countries, a single species costs from a few thousand dollars to tens of thousands of dollars.

According to the relevant provisions, commissioned processing of varieties in the production, the FDA in the place of production to be filed, but only in the importing country as a 'drug' to register and obtain the symbol, can be produced at the domestic GMP factory to proprietary Chinese medicines For example, in many countries, the legislation has not yet been implemented. The FDA's management of proprietary Chinese medicines has always been implemented according to the standards of pharmaceuticals but is still classified as 'dietary supplements' and therefore does not comply with China's filing requirements and affects the related companies in the United States In addition, the export of pharmaceutical products in China need to provide a certificate of export sales (CPP certificate), and most of the pharmaceutical specifications in Africa are different with our country, according to foreign specifications in the country to apply for registration and approval difficulties, resulting in Chinese enterprises can not undertake this part Drug orders, have to hand over the international market to Europe and the United States and India companies.

In the first three quarters of this year, the general situation of China's pharmaceutical foreign trade was good, and the restoring growth in the U.S. market, emerging markets such as India and Brazil contributed to the growth of exports in the year, and the export volume of bulk APIs, accounting for nearly half of all pharmaceutical exports, increased by 8.86% %, While the export volume increased by 7.04% over the same period of the previous year. This reflects that the demand for bulk raw materials in China remains strong in the international market. With the tightening of domestic environmental protection laws and regulations, the export prices of bulk raw materials have been pushed up. For example, cardiovascular system drugs rose by 117.6% , While that of raw materials for vitamins increased by 18.38% over the same period of last year. The export price of bulk APIs has risen from 1.56% in the first half of the year to 1.7% at present. However, some enterprises reported that although the market is in need of supply, The number of exports may shrink.

The growth momentum of imported products is good, but domestic encouragement of using large domestic equipment and bidding to reduce drug prices will affect the import of large-scale medical equipment and high-priced proprietary drugs.

With the State Council and the relevant departments in charge of stabilizing trade and promoting growth measures have been gradually implemented, combined with the recent "on deepening the reform of examination and approval system to encourage innovation in medical devices," "on the adjustment of imported drug registration management decisions The implementation of other policies in succession will be conducive to the healthy and stable development of foreign trade in medicine.

Based on a comprehensive analysis, based on the low base of foreign trade last year, the import and export of medicine is expected to increase by 10% to 12% in 2017, 5% to 7% in exports and 16% to 18% in imports.

How to improve the medical trade environment?

Strengthen the regulatory system, increase classification and control efforts

The relevant departments are advised to step up supervision and guidance on the macro-level, improve regulatory measures, and promptly phase out quality-standard non-compliant enterprises by cracking down on exports of counterfeit pharmaceutical products and curbing the vicious competition at low prices.

For the compliance enterprises, normal production during the heating season or normal operation of some production lines may be allowed for the qualified enterprises; stringent measures should be taken for those enterprises that fail to meet the standards to force them to strengthen their environmental protection investment Phase out.

In addition, exclusive varieties involving people's livelihood should be allowed to normal production.The government should formulate a unified pollutant disposal measures and standards, so that enterprises have rules to follow.Scientific institutions should increase research efforts in the field of environmental technology, and guide enterprises to solve the relevant pollution control Problems, reduce costs.

Foster leading enterprises and industrial clusters, pay attention to innovative factors

The government should step up its support to cultivate enterprises with good economic returns, strong driving forces and great potential for development as key leading enterprises. Encourage powerful enterprises to cooperate with each other to enhance economies of scale and build a business with a number of leading enterprises at their core Industrial clusters.

We should guide and encourage innovative resources. While making rational use of the technological advantages of leading enterprises, we should jointly build a joint innovation platform among enterprises and relying on long-term and stable cooperation mechanisms for scientific and technological innovation so as to enhance the technological innovation capability of enterprises under their jurisdiction and effectively promote the transformation and upgrading of enterprises.

Strengthen the standard system, speed up mutual recognition of international standards

For enterprises one by one through the quality certification of different countries, the huge cost of the actual situation, should strengthen the intergovernmental regulatory regulations, technical standards for communication and consultation, to increase foreign diplomacy, and promote international drug Standard docking and mutual recognition. With the international community to carry out regulatory cooperation, the use of multilateral and bilateral mechanisms to eliminate technical barriers to trade.At the same time, actively participate in international standards.If the health insurance chamber of commerce has developed and issued three batches of international standards for plant extracts in the country Outside the industry and get a better response, but also by the relevant government departments and inspection agencies fully affirmed.

Improve the import promotion system and improve the level of trade facilitation

Relevant departments should attach importance to play medicine The role of imports in national import strategies supports the cultivation of specialized imports Exhibition , And through long-term operation, form a brand import exhibition with complete, professional and influential industry chain; further simplify and relax some import management measures and revise and improve the policies that do not conform to the current development so as to enhance customs, commodity inspection and documents To handle the overall coordination of import agencies such as capacity.