Merck reviews pricing methods on a regular basis to ensure that our products are competitive and also accessible. In addition, Merck supports a zero-tariff approach to import tariffs, as advocated by WHO, because import tariffs in many countries represent a large portion of the price of medicines.
Merck regularly bids in developing country government tender processes to provide medicines at affordable prices. We offer products to governments at reduced rates in Africa, Latin America, and Southeast Asia, for example: metformin (diabetes) through Farmacia Popular in Brazil and Seguro Social in Mexico and in Guatemala; Eutirox (thyroid disorders) through Caja del Seguro Social in Costa Rica and the Cuban Health System; cefixime (antibiotic) to the South African health authorities; Concor, Concor Cor, Glucophage, Glucophage XR, Glucovance (diabetes), Thyrosol, Levothyrox (thyroid disorders) in government hospital tenders (MoH and SoH) through the official local distributor in Vietnam; and Concor, Euthyrox, Glucovance to the Ministry of Health in Malaysia.
Merck’s portfolio has more than 80 products that are on the WHO Essential Medicines List. They are currently distributed in 65 developing countries including 34 countries in Africa, 19 in Asia and 8 in Central and South America. These products are available in around 50% of Least Developed Countries (LDCs) such as Afghanistan, Benin, Burkina Faso, Ethiopia, Haiti, Mali, Senegal and Sudan. Prices are determined by our subsidiaries, taking local purchasing power into consideration.
Merck believes that local manufacturing is appropriate for particular products in developing countries. Local manufacturing and the transfer of and access to technology, skills and intellectual property are contingent on the guarantee of our quality and safety standards. All our products, whether for developed or developing markets, are produced in manufacturing plants that meet global Good Manufacturing Practices (GMPs).
A number of treatments for chronic diseases are produced in manufacturing plants located in countries such as, India, Pakistan and Indonesia. The drugs are distributed in the country of production and exported to developing countries such as Afghanistan, Maldives, Sri Lanka, Nepal and Kenya. We have initiated, and intend to continue exporting products manufactured in Pakistan and India to a range of African countries through local Merck offices in South Africa and Tunisia. Our manufacturing plant in Indonesia supplies developing countries across Southeast Asia.
Through our qualification program for our contract manufacturers, we support them to develop their quality system via coaching and consultancy where appropriate. We are currently engaged with a partner in Algeria that produces and handles the packaging of Glucophage for local distribution. Merck intends to further develop this local partner to perform further steps along the value chain for us.
We obtain marketing approval for our medicines available in developing countries. When deciding which products to register, we incorporate our patients’ needs for our products into our decision-making process.
Merck continuously works on guaranteeing product availability for its customers. Our requirements for quality and effectiveness of the distribution process are uniform worldwide. We are committed to performing rigorous and frequent checks on our distribution network to ensure that partners adhere to our quality and safety requirements and ensure full compliance with global Good Distribution Practices (GDPs).
Merck has global procedures for product recalls that apply worldwide. Recall responsibilities are clearly defined in contractual technical agreement with all our partners including distribution partners. We have a formal qualification program of partners that includes audits and follow-up.
We apply the international applicable pharmacovigilance standards in all countries. This ensures that patients consistently receive products which comply with Merck’s quality standards. On the African continent, this is mainly achieved via the local affiliates with local drug safety monitoring employees who continuously check the required regulations for pharmacovigilance of the countries of concerns for compliance. The affiliates also interact with third party business partners to ensure compliance for the distribution activities.
Operational local drug safety compliance is monitored via the company's quality assurance systems.
All the results of continuous global monitoring of the drug safety profile are to be followed up and implemented in all countries of product registration. This is to assure that patients worldwide are treated according to the latest therapy recommendations of the marketing authorization holder and the international health authorities.
Merck is committed to supporting initiatives surrounding the implementation of strict anti-counterfeiting measures to protect patient safety.
To operationalize this commitment, Merck is an active member of all major
industry associations including the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), and the Pharmaceutical Security Institute (PSI). Merck supports these institutions by providing research, policy support, technical advice and financial contributions in their fight against counterfeiting. We work in partnership with the relevant law enforcement and regulatory authorities around the world to ensure that counterfeiting laws are fully enforced.
In 2008, Merck founded the “
Merck Anti-Counterfeiting Operational Network (MACON)”. This cross-functional group comprises experts from different divisions including: legal/trademarks, product security, supply chain and quality assurance. It is managed and led by Corporate Security. It is the responsibility of MACON to supervise and implement anti-counterfeiting measures across all products at a global level. The group works to pool resources within Merck to detect and prevent the sale and use of counterfeits of all our products. It monitors world markets, internet activity, legislative developments and promptly reports any incidences of counterfeiting to the relevant law enforcement and regulatory bodies. The overriding aim is to secure “patient safety” worldwide.
Regarding technical operations, Merck is working on three product security layers:
Tamper-evidence, with the development, testing and introduction of tamper-proof seals.
Authentication, most notably with Merck-proprietary color-shifting pigment.
Identification, for which we have launched a Track & Trace program on selected products worldwide.
Merck works with a supplier to help detect anti-counterfeiting drugs by using a mobile identification system for drugs sold in Nigeria. After sending the scratched bar code encrypted on the package, patients receive a message about the authenticity of the drug. Merck is considering expansion of this program to other countries and for other drugs.
Also, with their characteristic color properties, Merck’s Candurin® pearl effect pigments help customers in the pharmaceutical industry to make tablets and capsules themselves more difficult to counterfeit.
The GPHF Minilab is a portable quality analysis kit that allows the detection of substandard drugs and counterfeit medicines in the field. It provides a rapid, simple and inexpensive test method to verify drug appearance, identity, content and release of 57 drug compounds. The focus is on the most commonly used medicines for treating infectious diseases. Due to the compact nature of the Minilab the tool is well suited for testing in the field. In this way it helps to bridge capacity gaps on drug quality control in developing countries.
More information
