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Ladies and Gentlemen of the media, the Executive Chairman, Mr. Samuel Amo Tobbin, Management and the entire staff of Tobinco Pharmaceuticals Limited, wish to appreciate your presence here at a rather short notice. We are extremely grateful. We called you here to brief you about the latest development on the impasse between TOBINCO Pharmaceuticals Limited (TPL) and the Food and Drugs Authority (FDA) thereby setting the records straight. Re- Assurance on Public Health and Safety TOBINCO Pharmaceuticals Limited would like to seize this opportunity to reassure and guarantee the public that it will continue to maintain the quality, safety and efficacy of its products beyond its thirteen years in the pharmaceutical industry. We therefore wish to assure the general public that TOBINCO is committed to ensuring public health and safety and have never and will not compromise on this. Anti-Malarials TOBINCO has been one of the main distributors of pharmaceutical products in the country. The company has been the largest distributor of high quality, efficacious, affordable and accessible anti-malaria medicines in the country. Not only do TOBINCO's anti-malarials compete in quality, it is affordable and distributed to the remotest part of the country. TOBINCO has the widest pharmaceutical distribution network in Ghana. For instance, TOBINCO is the only pharmaceutical company that goes as far as Tumu for doorstep delivery. TOBINCO has contributed immensely towards the reduction of malaria prevalence in the country. The consistent increase in the patronage of TOBINCO�s anti-malarials over the years corresponds with the reduction of malaria mortality and mobidity in the country by approximately 50% as at 2010(reference to National Malaria Control Programme Report 2009). This reduction would contribute to Ghana�s achievement of the Millennium Development Goals (MDG - 6) by 2015. In spite of our contribution to this success we are being restricted by the FDA. What Brought TOBINCO Here? What has led to the recent state of affairs about registration of products with the Food and Drugs Authority is a misjudgment and delayed action on our part, and has nothing to do with the integrity of our products. A penalty imposed by the Authority in connection with the registration issues has been duly paid. The issues have been as follows: 1. The "Apology Letter" - The importation of Gsunate plus suppository (anti-malarial � Artesunate/ Amodiaquine) without clinical trials being conducted by the manufacturer which led to the writing of the "apology" letter. 2. Registration of Medicines - The importation of some medicines pending registration and re-registration status The "Apology Letter" The letter came about through the insistence of Dr. Stephen Opuni that the CEOs of TOBINCO and Bliss GVS should write a letter apologizing for bringing in medicinal products without registration. He assured them that this letter and the paid fine would be sufficient to facilitate the process of regularizing the registration protocols. Whilst they were on their way to prepare the letter and seek legal advice, they were abducted and taken to the BNI office. The letter was prepared, but before they could submit it, Dr. Stephen Opuni sent his officers to insist that an additional statement "I sincerely apologize for importing fake (Gsunate plus) anti-malarial into the country" must be included. By this time, the abduction and the continuous stay at the security agency premises had had its toll on the two CEOs. To gain their freedom and to allow the CEO of BLISS GVS to take his medication and return to his home country, they were made to sign the letters under duress. Whilst admitting that the CEOs of the companies involved should not have signed the letters, it is the duty of the regulator (FDA) to determine the efficacy of the products but not to depend on statements from anybody. If a company writes to FDA stating that the efficacy of its product is good, would that be enough evidence to declare to the public that the company's products are good? Wouldn't the public expect the regulator to undertake an independent test of the products to attest its efficacy? Why then would the FDA declare that a letter written by a pharmaceutical company stating that the products are "fake" is enough to warrant causing panic and mayhem to the public and the subsequent banning of the company illegally. Under section 116 of the Public Health Act 2012, Act 851, it is only the Minister who may, by executive instrument, prohibit the importation, manufacture, exportation, advertisement or sale of a drug. Can we say that, if the FDA has been relying on only written evidence rather than scientific analysis to determine the efficacy of medicinal products distributed in Ghana then the public health is at risk? This is regulation based on writing rather than testing. So far, FDA has not brought any scientific proof on the assertions that it has made regarding TOBINCO's products. This leads us to the conclusion that there is no scientific basis for FDA's declaration of TOBINCO's medicines "fake". The mere fact that TOBINCO has distributed millions of doses of anti-malaria medicines over the last three years without any reported treatment failures, does to some extent, attest to its efficacy, safety and customers trust. This TOBINCO FDA impasse is adversely affecting the poor, rural dweller whose only hope for efficacious, quality and affordable medicines is through TOBINCO's effective and extensive distribution network. Our contribution to the reduction of malaria mortality and mobility in Ghana cannot be ignored. Whilst FDA is flexing its regulatory muscles against Tobinco and locking up warehouses, it is depriving many citizens of their right to affordable efficacious medicine through Tobinco's distribution network. Market information gathered indicates that certain remote areas in the three Northern Regions and the Northern Volta are out of stock of affordable anti-malarials. Also, there are recent cases of shortages of anti-malarials in some medical facilities in the country. These medicines are available in our warehouses locked by FDA. The shortages can cause an in-flux of counterfeit medicines. This is a national issue and we are calling on the government to intervene. Registration of Medicines Registration of Pharmaceutical products has always been challenging. Some of the bottlenecks include: 1. Undue delays of the process 2. Lack of transparency 3. Inadequate communication with the applicant TOBINCO wrote to FDA to seek approval for extension of the re-registration of its medicines in view of the planned opening of ultra-modern pharmaceutical manufacturing plant in the ensuing year. Being fully aware of the progress of the manufacturing plant, FDA granted TOBINCO a waiver and extension on the re-registration until the factory is completed. [See attached FDA letter on local manufacture waiver as annex 1] Unfortunately, the planned date for commissioning the plant has been delayed due to our quest to meet international quality standards. It also worth noting that for these registration issues, a fine of GH 40,000.00 was imposed on TOBINCO which was duly paid. For medicines whose registration with FDA was not current, TOBINCO duly submitted appropriate documents and samples. It is worth referring again to the fact, mentioned above, that one of our suppliers (GVS BLISS) had made payment of USD 57,000 for re-registration of 28 medicines in 2011 directly to FDA account. Unfortunately, a communication gap between FDA and ourselves around that time delayed our submission of the supporting documents and sample relating to the re-registration process. The registration status of these 28 products had been pending until now. TOBINCO has since provided dossiers (documents) for registration and re-registration of its products. Over 35 dossiers have so far been submitted with a corresponding payment of $105,000 for re-registration. All the dossiers submitted have been deferred by the FDA. In addition, dossiers submitted for new registration were rejected. TOBINCO�s Actions Tobinco Pharmaceuticals Limited complied with all the directives of the FDA regarding Gsunate Plus suppositories and paid a fine of GHC40, 000.00 for the importation of Gsunate Plus. We have done a very comprehensive recall of the medicine from the market and submitted the recall forms and products to the FDA. With respect to an issue of certain condoms having failed tests done by FDA laboratory, the supplier of the condoms retested their retained samples in an ISO- certified laboratory and found them compliant with all test parameters. These results have been shared with the FDA and we have not had any response yet. Is the TOBINCO/FDA Impasse a Personal Attack? TOBINCO has reasons to revise its initial thoughts that the CEO of FDA was acting in the interest of public health without any personal vindictiveness and would like to share these thoughts with the public. � Dr. Opuni�s Statement (Threats and Abuse) Ladies and Gentlemen of the press, it will interest you to know that, basking in the full glory of his position, Dr. Stephen Opuni in peacock style, openly told the CEO of TOBINCO; �You wait, I am not done with you yet, if you do not know, I am a merciless being and will bring TOBINCO down�. He continued, �if you do not know, go and ask Semanhyia, I harassed her until her husband committed suicide and she went mad dying in a shrine�. Are Dr Opuni�s subsequent actions fulfilling his threats to the CEO of TOBINCO? � FDA Tactics The CEO of FDA, Dr. Stephen Opuni has been using communist inferior tactics to frustrate the efforts of TOBINCO in resolving the issues at stake. On several occasions, when Dr. Opuni has requested cease fire from media, he has gone ahead to harass the company in many ways including the media. In like manner, when TOBINCO was compelled to sue FDA, Dr. Opuni lured TOBINCO to withdraw the case from court as a condition for submitting to mediation. On Monday, 18th November, 2013 a high powered four member Management Team from Tobinco went to see the CEO of FDA in his office to try and resolve the matter. Sadly he refused to see them. The team had to sit down till close of day when the receptionist told them to leave because they had closed. Following the withdrawal of the court case, Pharmacists, Regional Medical Stores, Teaching Hospitals, Pharmacies, Clinics and Chemical Shops in Ghana came under severe attacks from the FDA, For example: � Goaso Pharmacist � The DDPS at Wa Regional Health Directorate � Costa Pharmacy in Kumasi � Kama Health Services in Kumasi � Aseda Pharmacy in Kumasi As if that was not enough, FDA with the support of EOCO embarked on a further onslaught on TOBINCO through the locking up of its warehouses and in the process TOBINCO staff members were severally assaulted. � A Security Officer on duty was assaulted, arrested and placed in police custody overnight. � Staff Members were harassed. Doors and windows to the official residence for staff members at Alajo were forcibly opened and the occupants (family of TOBINCO staff) were asked to get out of their rooms to allow them (FDA/EOCO) official conduct search in their rooms. � A driver was also arrested and handcuffed at Entrance Industries & Research Centre We will like to clarify that contrary to the assertion of EOCO and FDA all Tobinco�s warehouses are known and have always been accessible to the regulatory authority. Goods at the Port Ladies and Gentlemen of the media, currently TOBINCO has about 30 containers of our products at the port suffering the adverse effects of the sun because the FDA has refused clearance even though the medicines were imported before this impasse. We would like to correct the erroneous impression given by the FDA that TOBINCO has imported goods after this impasse. These medicines were either at the port or on the high seas before October 1 i.e. the banning of GVS BLISS. Moreover, most of these products are from other manufacturing partners of TOBINCO including but not limited to CIPLA, IPCA, ALLY PHARMA, OSAKA, who equally manufacture for other pharmaceutical companies in Ghana. The FDA has refused TOBINCO to clear the goods at the port. Furthermore, it has come to our notice that the FDA has written to port authorities to prevent re-exporting of the products back to the manufacturers and rather strangely, is asking that we move the medicines in the containers to State Warehouse, where they will remain at the mercy of the weather and TOBINCO to continue incur cost in demurrage and other incidental charges. [Attached as annex 5: List of the imports and their shipment and arrival date] Ladies and Gentlemen, we wish to emphatically state that every product of TOBINCO came to the country through the approved ports of entry for medicines which is Tema port and Kotoka International Airport. Clearance is only done after inspection and issuance of clearing permit by the FDA. Without the approval of the FDA, medicines cannot be cleared from the port. Entrance Industries Ltd & Research Centre Ladies and gentlemen of the media, the health and wellbeing of the nation are our priority concerns and we will continue to contribute our quota through the provision of quality medicines. In line with this objective, Tobinco Pharmaceuticals Limited has established Entrance Industries Ltd & Research Centre, a cutting - edge ultra- modern manufacturing facility with quality standards that meet that of the World Health Organization. The FDA and University of Ghana School of Pharmacy are third parties to the joint project by TOBINCO, German Technical Cooperation, GIZ and 1A Pharma, Germany, to set up the first Pharmaceutical Research Centre incorporated in the manufacturing facility. [Attached as annex 6: Developpp.de Concept for Research Centre] It therefore comes as a huge surprise to TOBINCO that this facility which is a separate entity could be described and called a warehouse and come under attack by officials of FDA and EOCO on 21st November, 2013. Conclusion Ladies and Gentlemen of the media having not being distributing our products for the past three months has brought a heavy toll on us, physically, mentally and financially since we have been paying our workers all this while for fear of letting them become redundant. We want to know whether it is part of the FDA�s agenda to stifle, strangulate, suffocate and chase a local pharmaceutical company like ours out of business. We are therefore appealing to the President of Ghana, His Excellency John Dramani Mahama to use his good office to intervene in this matter. He should take it as his personal agenda to protect the sustenance of local industries or private capital in Ghana. We know the President to be very peaceful, affable and respectable gentlemen who will not condone the use of government machinery, to harass innocent citizens much less intimidate indigenous entrepreneurs out of business. We therefore wish to once again assure the general public that TOBINCO is committed to ensuing public health and safety and have never and will not compromise on this. Thank you very much Dr. Peter Tobbin Member, TOBINCO Communication Team Editor�s Note: About TOBINCO Pharmaceuticals Limited (TPL) TOBINCO Pharmaceuticals Limited (TPL) is currently one of the leading pharmaceutical marketing and distribution company in Ghana and looking forward to producing other products locally and for the Sub- Regional Market TPL seeks to gain a significant share of the African market with its own brand in the first year of manufacturing operations. It has historically focused more on marketing and distribution of ACT�s and in recent times increased its range to cover over the counter drugs (OTC�s) Mission To consistently deliver the safest, high quality and most potent pharmaceutical and other healthcare products, using highly motivated and competent human capital with an incredible passion for innovation, excellent and superior customer care Vision Aspire to be the market leader in the provision of high quality pharmaceuticals and other health care products in Ghana and the African sub-region Values � Customer focus � Integrity � Innovation � Excellence � Teamwork � confidentiality � commitment � people development